Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
108
Countries
5
Sites
18
Persistent or Recurrent Rare Epithelial Ovarian Tumors
To evaluate the efficacy of biomarker-driven treatments based on confirmed objective response rate (ORR) as determined by the investigator
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Aug 2021 → ongoing
- Decision date (initial)
- 2024-02-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- F. Hoffmann-La Roche Ltd
External identifiers
- EU CT number
- 2023-508194-89-00
- EudraCT number
- 2020-004936-72
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the efficacy of biomarker-driven treatments based on confirmed objective response rate (ORR) as determined by the investigator
Secondary objectives 4
- To evaluate the efficacy of biomarker-driven treatments based on duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS) as determined by the investigator and by the Independent Review Committee and 6-month PFS rate as determined by investigator
- To evaluate the efficacy of biomarker-driven treatments based on overall survival (OS)
- To evaluate the efficacy of biomarker-driven treatments based on confirmed ORR as determined by the Independent Review Committee
- To evaluate the safety of biomarker-driven treatments
Conditions and MedDRA coding
Persistent or Recurrent Rare Epithelial Ovarian Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061328 | Ovarian epithelial cancer | 100000004864 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Prescreening Patients will be prescreened for biomarker and pathology eligibility
|
Not Applicable | None | ||
| 2 | Treatment Period Patients who have an eligible tumor histology and a tumor biomarker profile that matches an open and enrolling treatment arm will be offered the treatment arm-specific.
|
Not Applicable | None | Ipat-Pac: ipatasertib plus paclitaxel Cobi: cobimetinib T-DM1: trastuzumab emtansine Atezo-Bev: atezolizumab plus bevacizumab Gire-Abema: giredestrant plus abemaciclib Inavo-Palbo: inavolisib plus palbociclib Inavo-Palbo-Let: inavolisib plus palbociclib plus letrozole Inavo-Ola: inavolisib plus olaparib Inavo-Gire: giredestrant plus inavolisib Inavo-Bev: inavolisib plus bevacizumab Atezo-Bev-Cyclophosphamide: atezolizumab plus bevacizumab and cyclophosphamide |
|
| 3 | Post-treatment follow-up After treatment discontinuation, information on survival status and new anti-cancer therapy will be collected until death (unless the patient withdraws consent or the Sponsor terminates the study).
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Persistent or recurrent epithelial ovarian cancer (EOC) that meets the following criteria: a) Histologically confirmed non-high-grade serous, non-high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (including but not limited to low-grade serous ovarian cancer, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma, and small cell carcinoma of the ovary, hypercalcemic type). A primary gastrointestinal carcinoma must have been excluded. b) Disease that is not amenable to curative surgery
- Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Previous treatment with one to four lines of therapy, at least one of which was platinum-based. Hormonal therapy does not count as a line of therapy
- Platinum-resistant disease (defined as disease progression during or within 6 months of last platinum therapy) with the following exception: patients with primary platinum-refractory disease are excluded.
- At the time of prescreening, submission of a representative tumor specimen that is suitable for NGS testing and ER IHC to determine treatment arm assignment and for central pathology review.
Exclusion criteria 6
- Histologic diagnosis of high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer
- Current diagnosis of solely borderline epithelial ovarian tumor (formerly considered tumors of low malignant potential)
- Current diagnosis of non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord-stromal tumors)
- Current diagnosis of synchronous primary endometrial cancer
- Primary platinum-refractory disease, defined as progression during or within 4 weeks after the last dose of the first-line platinum treatment
- History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Confirmed ORR as determined by the investigator according to RECIST v1.1
Secondary endpoints 7
- 1. DOR as determined by the investigator and IRC according to RECIST v1.1
- 2. DCR as determined by the investigator and IRC according to RECIST v1.1
- 3. PFS as determined by the investigator and IRC according to RECIST v1.1
- 4. Overall survival
- 5. Confirmed ORR, as determined by the IRC according to RECIST v1.1
- 6. Six (6)-month PFS rate as determined by the investigator
- 7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 30
Tecentriq 1,200 mg concentrate for solution for infusion
PRD5434939 · Product
- Active substance
- Atezolizumab
- Substance synonyms
- RO5541267
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF05 — -
- Marketing authorisation
- EU/1/17/1220/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
Lynparza 150 mg film-coated tablets
PRD6152234 · Product
- Active substance
- Olaparib
- Substance synonyms
- AZD-2281, AZD2281
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XX46 — -
- Marketing authorisation
- EU/1/14/959/005
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/07/501
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
Lynparza 100 mg film-coated tablets
PRD6163465 · Product
- Active substance
- Olaparib
- Substance synonyms
- AZD-2281, AZD2281
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XX46 — -
- Marketing authorisation
- EU/1/14/959/003
- MA holder
- ASTRAZENECA AB
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/07/501
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
Lynparza 100 mg film-coated tablets
PRD6163467 · Product
- Active substance
- Olaparib
- Substance synonyms
- AZD-2281, AZD2281
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XX46 — -
- Marketing authorisation
- EU/1/14/959/002
- MA holder
- ASTRAZENECA AB
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/07/501
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
Lynparza 150 mg film-coated tablets
PRD6152224 · Product
- Active substance
- Olaparib
- Substance synonyms
- AZD-2281, AZD2281
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XX46 — -
- Marketing authorisation
- EU/1/14/959/004
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/07/501
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
Endoxan 50 mg dengtos tabletės
PRD349513 · Product
- Active substance
- Cyclophosphamide Monohydrate
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- LT/1/97/3087/001
- MA holder
- BAXTER ONCOLOGY GMBH
- MA country
- Lithuania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
Paclitaxel 6 mg/ml Concentrate for Solution for Infusion
PRD2002565 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 80 mg/m2 milligram(s)/sq. meter
- Max total dose
- 80 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- PL 20075/0128
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
Paclitaxel Actavis 6 mg/ml koncentrat till infusionsvätska, lösning
PRD928325 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 80 mg/m2 milligram(s)/sq. meter
- Max total dose
- 80 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 24615
- MA holder
- ACTAVIS GROUP PTC EHF.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
Sindaxel 6 mg/ml concentrat pentru soluţie perfuzabilă
PRD4356093 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 80 mg/m2 milligram(s)/sq. meter
- Max total dose
- 80 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 9154/2016/03
- MA holder
- TEVA B.V
- MA country
- Romania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
PACLITAXEL AHCL 6 mg/ml, solution à diluer pour perfusion
PRD4609805 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 80 mg/m2 milligram(s)/sq. meter
- Max total dose
- 80 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 34009 586 774 9 6
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
IBRANCE 125 mg film-coated tablets
PRD7907865 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/014
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
IBRANCE 75 mg film-coated tablets
PRD7907995 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/010
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
IBRANCE 100 mg film-coated tablets
PRD7907867 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/012
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
PRD9491575 · Product
- Active substance
- Giredestrant
- Substance synonyms
- 3-((1R,3R)-1-(2,6-DIFLUORO-4-((1-(3-FLUOROPROPYL)AZETIDIN-3-YL)AMINO)PHENYL)-3-METHYL-1,3,4,9-TETRAHYDRO-2H-PYRIDO(3,4-B)INDOL-2-YL)-2,2-DIFLUOROPROPAN-1-OL, RG-6171, GDC-9545, RO7197597
- Other product name
- GDC-9545, Giredestrant
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
LETRO-cell® 2,5 mg Filmtabletten
PRD1953066 · Product
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 2.5 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- 68968.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
PRD9859715 · Product
- Active substance
- Ipatasertib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9859714 · Product
- Active substance
- Ipatasertib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Cotellic 20 mg film-coated tablets
PRD3439656 · Product
- Active substance
- Cobimetinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EE02 — -
- Marketing authorisation
- EU/1/15/1048/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
PRD10777046 · Product
- Active substance
- Cobimetinib
- Other product name
- RO5514041
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10784718 · Product
- Active substance
- Cobimetinib
- Other product name
- RO5514041
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10777048 · Product
- Active substance
- Cobimetinib
- Other product name
- RO5514041
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Verzenios 50 mg film-coated tablets
PRD6701102 · Product
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/011
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
Verzenios 100 mg film-coated tablets
PRD6701107 · Product
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/013
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
Verzenios 150 mg film-coated tablets
PRD6701112 · Product
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/015
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
Kadcyla 160 mg powder for concentrate for solution for infusion.
PRD2154040 · Product
- Active substance
- Trastuzumab Emtansine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 3.6 mg/Kg milligram(s)/kilogram
- Max total dose
- 3.6 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FD03 — -
- Marketing authorisation
- EU/1/13/885/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
Avastin 25 mg/ml concentrate for solution for infusion.
PRD2153902 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 15 mg/Kg milligram(s)/kilogram
- Max total dose
- 15 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/04/300/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeled for Clinical Trial use
PRD9793132 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 9 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793809 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 9 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793811 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 9 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793130 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 9 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Q2q Communications Limited ORG-100041455
|
Richmond, United Kingdom | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Other |
Locations
5 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 3 | 2 |
| France | Ongoing, recruitment ended | 32 | 8 |
| Germany | Ongoing, recruitment ended | 7 | 2 |
| Italy | Ended | 10 | 2 |
| Spain | Ongoing, recruitment ended | 5 | 4 |
| Rest of world
Australia, United States, Russian Federation, Canada, United Kingdom, Turkey, Switzerland, Korea, Republic of
|
— | 51 | — |
Investigational sites
Fakultni Nemocnice Brno
Gynekologicko-porodnicka klinika, Jihlavska 340/20, Bohunice, Brno
Vseobecna Fakultni Nemocnice V Praze
Gynekologicko-porodnicka klinika, Apolinarska 441/18 Nove Mesto, 128 00, Prague
Centre Francois Baclesse
oncologie, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Hospitalier Universitaire De Toulouse
oncologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Saint Joseph Saint Luc
oncologie, 20 Quai Claude Bernard, 69007, Lyon
Institut Gustave Roussy
oncologie, 114 Rue Edouard Vaillant, 94800, Villejuif
Groupe Hospitalier Diaconesses Croix Saint Simon
oncologie, 125 Rue D Avron, 75020, Paris
Centre De Lutte Contre Le Cancer Eugene Marquis
oncologie, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Besancon University Hospital Center
oncologie, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Universitaire De Nantes
oncologie, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Gynäkologie & Gynäkologische Onkologie, Henricistrasse 92, Huttrop, Essen
Universitaetsklinikum Mannheim GmbH
Konservative Gynäkologische Onkologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Unità Operativa Oncologia Medica Uro-Ginecologica, Via Mariano Semmola 52, 80131, Naples
Ospedale San Raffaele S.r.l.
Ginecologia oncologica, Via Olgettina 60, 20132, Milan
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario La Paz
Oncology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2021-10-14 | 2025-01-02 | 2021-11-22 | 2023-04-22 | |
| France | 2021-10-22 | 2021-10-22 | 2024-04-22 | ||
| Germany | 2021-10-29 | 2021-11-03 | 2024-04-22 | ||
| Italy | 2021-10-12 | 2025-07-01 | 2021-10-21 | 2024-04-22 | |
| Spain | 2021-08-30 | 2021-11-03 | 2024-04-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 208 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol Clarification Letter 2023-508194-89-00 | NA |
| Protocol (for publication) | D1_Protocol 2023-508194-89-00 Redacted.pdf | 1 (EEA) |
| Protocol (for publication) | D1_Protocol Clarification Letter 2023-508194-89-00 dated Dec 2023_Redacted | N/A |
| Protocol (for publication) | D1_Protocol Clarification Letter 2023-508194-89-00 dated Sep 2023_Redacted | N/A |
| Protocol (for publication) | D4_Patient Facing Documents_Dosing Instructions_Cobi_CZ | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Dosing Instructions_Cobi_DE | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Dosing Instructions_Cobi_ENG | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Dosing Instructions_Cobi_ES | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Dosing Instructions_Cobi_FR-FR | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Dosing Instructions_Cobi_IT | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Glucose Diary_all Inavo_CZ | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Glucose Diary_all Inavo_DE | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Glucose Diary_all Inavo_ENG | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Glucose Diary_all Inavo_ES | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Glucose Diary_all Inavo_FR-FR | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Glucose Diary_all Inavo_IT | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Glucose Diary_Ipat+Pac_CZ | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Glucose Diary_Ipat+Pac_DE | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Glucose Diary_Ipat+Pac_ENG | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Glucose Diary_Ipat+Pac_ES | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Glucose Diary_Ipat+Pac_FR-FR | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Glucose Diary_Ipat+Pac_IT | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Cyclophosphamide_CZ | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Cyclophosphamide_DE | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Cyclophosphamide_ENG | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Cyclophosphamide_ES | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Cyclophosphamide_FR-FR | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Cyclophosphamide_IT | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Gire+Abema_CZ | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Gire+Abema_DE | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Gire+Abema_ENG | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Gire+Abema_ES | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Gire+Abema_FR-FR | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Gire+Abema_IT | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Bev_CZ | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Bev_DE | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Bev_ENG | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Bev_ES | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Bev_FR-FR | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Bev_IT | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Gire_CZ | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Gire_DE | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Gire_ENG | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Gire_ES | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Gire_FR-FR | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Gire_IT | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Ola_CZ | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Ola_DE | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Ola_ENG | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Ola_ES | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Ola_FR-FR | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Ola_IT | 2 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Palbo_CZ | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Palbo_DE | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Palbo_ENG | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Palbo_ES | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Palbo_FR-FR | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Palbo_IT | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Palbo+Len_CZ | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Palbo+Len_DE | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Palbo+Len_ENG | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Palbo+Len_ES | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Palbo+Len_FR-FR | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Inavo+Palbo+Len_IT | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Ipat_CZ | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Ipat_DE | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Ipat_ENG | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Ipat_ES | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Ipat_FR-FR | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient Diary_Ipat_IT | 1 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient ID Card_CZ | 3 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient ID Card_DE | 3 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient ID Card_ENG | 3 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient ID Card_ES | 3 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient ID Card_FR-FR | 3 |
| Protocol (for publication) | D4_Patient Facing Documents_Patient ID Card_IT | 3 |
| Recruitment arrangements (for publication) | K_Recruitment arrangement | NA |
| Recruitment arrangements (for publication) | K_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Document additionnel_redacted | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_WO42178_CZ | 1 |
| Recruitment arrangements (for publication) | K1_Recuritment arrangements | NA |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Principal_Inavo_Beva_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_General Atezo_Bev_Cyclo_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_General Inavo_Beva_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_General Inavo_Gire_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_General_Atezo_Beva | NA |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_General_Cobimetinib | 3 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_General_Gire_Abema | NA |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_General_Inavo_Ola_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_General_Inavo_Palbo | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_General_Inavo_Palbo_Letro | NA |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_General_Ipat_Pacli | 3 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_General_Kadcyla | 3 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Optional biopsy Atezo_Bev | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Optional biopsy_Atezo_Bev_Cyclo | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Optional biopsy_Cobi | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Optional biopsy_Gire_Abema | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Optional biopsy_Inav_Ola | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Optional biopsy_Inav_Palbo | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Optional biopsy_Inav_Palbo_Letro | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Optional biopsy_Inavo_Bev | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Optional biopsy_Inavo_Gire | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Optional biopsy_Ipat_Pacli | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Optional biopsy_Kadcyla v2_2021_04_05 | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Prescreening_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_RBR_Atezo_Bev | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_RBR_Atezo_Bev_Cyclo | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_RBR_Cobi | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_RBR_Gire_Abema | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_RBR_Inav_Ola | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_RBR_Inav_Palbo v1_2022_05_12 | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_RBR_Inavo_Bev | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_RBR_Inavo_Gire | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_RBR_Inavo_Palbo_Letro | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_RBR_Ipat_Pacli | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_RBR_Kadcyla | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF RBR Ipat_Pacli | NA |
| Subject information and informed consent form (for publication) | L1_privacy consent form other subjects | 1Nov23 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _Inavo Palbo Let_TC | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Atezo_Bev_REDACTED | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Atezo_Beva_Cyclophosphamide | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cobimetinib | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Gire_Abema | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Inavo_Beva | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Inavo_Gire | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Inavo_Ola | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Inavo_Palbo | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Inavo_Palbo_Let | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Ipat_Pacli | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Kadcyla | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Inavo and Gire_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF prescreening | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF prescreening_Final_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Principal_Atezo bev_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Principal_Atezo bev_TC_Not redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF principal_Atezo_Beva_Cyclo_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Principal_Gire_Abema_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Principal_Gire_Abema_TC_Not redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR Atezo_Bev | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR Atezo_Beva_Cyclophosphamide | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR Cobimetinib | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR Gire_Abema | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR Inavo_Beva | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR Inavo_Gire | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR Inavo_Ola | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR Inavo_Palbo | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR Inavo_Palbo_Let | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR Kadcyla | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Disease Worsening_Atezo and Bava and CFA_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Disease Worsening_Atezolizumab and Bavacizumab_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Atezolizumab and Bevacizumab and CFA_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Atezolizumab and Bevacizumab_WO42178_CZ | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Cobimetinib_WO42178_CZ | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Giredestrant and Abemaciclib_WO42178_CZ | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Inavolisib and Bevacizumab_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Inavolisib and Giredestrant_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Inavolisib and Olaparib_WO42178_CZ | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Inavolisib and Palbociclib and Letrozol_WO42178_CZ | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Inavolisib and Palbociclib_WO42178_CZ | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Ipatasertib and Paclitaxel_WO42178_CZ | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Kadcyla_WO42178_CZ | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional biopsies_WO42178_CZ | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening_WO42178_CZ | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_principal_Inavo Palbo | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_principal_Inavo_Gire_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_principal_Inavo_Palbo_TC | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and ICF Inavo_Palbo v4 | 4 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF principal_Atezo_Beva_Cyclo_TC Not redcated | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_principal_Inavo_Ola_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_principal_Inavo_Palbo_Let | 3 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF Prescreening_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF_MAIN_Atezo and Bev and Cyclo_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF_MAIN_Atezo and Bev_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF_MAIN_Cobi | 4 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF_MAIN_Gire and Abema_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF_MAIN_Inavo and Beva_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF_MAIN_Inavo and Gire_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF_MAIN_Inavo and Ola_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF_MAIN_Inavo and Palbo | 2 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF_MAIN_Inavo and Palbo and Letro | 2 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF_MAIN_Ipat and Pac | 4 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF_MAIN_TrastuzumabEmtansin | 3 |
| Subject information and informed consent form (for publication) | L1_WO42178_DEU_ICF_RBR | 1 |
| Subject information and informed consent form (for publication) | L2_other SI materials_Patient ID Card_WO42178_CZ | 3 |
| Subject information and informed consent form (for publication) | L3_other SI material_Pt diary_Atezo and Beva and CFA_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_other SI material_Pt diary_Giredestrant and Abemaciclib_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_other SI material_Pt diary_Inavolisib and Bevacizumab_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_other SI material_Pt diary_Inavolisib and Giredestrant_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_other SI material_Pt diary_Inavolisib and Olaparib_WO42178_CZ | 2 |
| Subject information and informed consent form (for publication) | L3_other SI material_Pt diary_Inavolisib and Palbociclib and Letrozol_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_other SI material_Pt diary_Inavolisib and Palbociclib_WO42178_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_other SI material_Pt dosing instructions_Cobimetinib_WO42178_CZ | 2 |
| Subject information and informed consent form (for publication) | L3_other SI material_Pt glucose diary_all Inavolisib arms_WO42178_CZ | 2 |
| Subject information and informed consent form (for publication) | L3_other SI material_Pt glucose diary_Ipatasertib and Paclitaxel_WO42178_CZ | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Endoxan 50 mg dengtos tabletes | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ibrance | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ibrance redline | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC LETRO-cell | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lynparza | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paclitaxel | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paclitaxel redline | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ 2023-508194-89-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2023-508194-89-00.pdf | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2023-508194-89-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR-FR 2023-508194-89-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT 2023-508194-89-00 | 4 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-19 | Germany | Acceptable 2024-02-08
|
2024-02-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-27 | Germany | Acceptable 2024-07-08
|
2024-07-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-29 | Germany | Acceptable 2025-02-17
|
2025-02-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-07 | Germany | Acceptable 2025-07-01
|
2025-07-01 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-03 | Germany | Acceptable 2025-12-21
|
2025-12-22 |