Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
932
Countries
8
Sites
14
KRAS p.G12C Mutant Advanced Solid Tumors
Phase 1 Part 1a and Part 2a Monotherapy Cohorts (Once Daily [QD] Dosing) – Advanced Solid Tumors -To evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors - To estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects w…
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 31 May 2019 → ongoing
- Decision date (initial)
- 2024-04-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Amgen Inc.
External identifiers
- EU CT number
- 2024-511798-31-00
- EudraCT number
- 2018-001400-11
- WHO UTN
- U1111-1303-7010
- ClinicalTrials.gov
- NCT03600883
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Efficacy, Pharmacodynamic, Pharmacokinetic, Safety
Phase 1 Part 1a and Part 2a Monotherapy Cohorts (Once Daily [QD] Dosing) – Advanced
Solid Tumors
-To evaluate the safety and tolerability
of AMG 510 in adult subjects with
KRAS p.G12C mutant advanced solid
tumors
- To estimate the maximum tolerated
dose (MTD) and/or a recommended
phase 2 dose (RP2D) in adult
subjects with KRAS p.G12C mutant
advanced solid tumors
Phase 1 Part 1b and Part 2b Monotherapy Cohorts (Twice Daily [BID] Dosing) –
Advanced Solid Tumors
Phase 1 Part 1d and Part 2d Monotherapy Cohorts (QD) – Advanced Solid Tumors
(Fed State)
- To evaluate the safety and tolerability
of AMG 510 in adult subjects with
KRAS p.G12C mutant advanced solid
tumors
Phase 1 Part 1c and Part 2c Pembrolizumab Combination Therapy Cohorts – Advanced
Non-small Cell Lung Cancer (NSCLC)
-To evaluate the safety and tolerability
of AMG 510 in combination with
pembrolizumab in adult subjects with
KRAS p.G12C mutant advanced
NSCLC
Phase 1 Part 2e Previously Untreated Metastatic NSCLC Monotherapy Cohort (QD)
- To evaluate the safety and tolerability
of AMG 510 in adult subjects with
previously untreated, KRAS p.G12C
mutant metastatic NSCLC
- To evaluate tumor response assessed
by Response Evaluation Criteria in
Solid Tumors (RECIST) 1.1 of
AMG 510 as monotherapy in adult
subjects with previously untreated
KRAS p.G12C mutant metastatic
NSCLC
Phase 2 Part A – NSCLC, CRC, and other tumor types
(AMG 510 monotherapy)
-To evaluate tumor objective response
rate (ORR) assessed by RECIST 1.1
criteria of AMG 510 as monotherapy in
subjects with KRAS p.G12C mutated
advanced tumors (NSCLC, colorectal
cancer [CRC], and other tumor types)
Phase 2 Part B – NSCLC (Dose Comparison Study)
-To evaluate tumor objective response
rate (ORR) assessed by RECIST 1.1
criteria of AMG 510 960 mg QD and 240
mg QD as monotherapy in previously
treated subjects with KRAS p.G12C
mutated advanced NSCLC
-To evaluate the safety and tolerability of
AMG 510 960 mg QD and 240 mg QD in
previously treated subjects with
KRAS p.G12C-mutated advanced
NSCLC.Phase 1 Part 1b and Part 2b Monotherapy Cohorts (Twice Daily [BID] Dosing) –
Advanced Solid Tumors
Phase 1 Part 1d and Part 2d Monotherapy Cohorts (QD) – Advanced Solid Tumors
(Fed State)
- To evaluate the safety and tolerability
of AMG 510 in adult subjects with
KRAS p.G12C mutant advanced solid
tumors.Phase 1 Part 1c and Part 2c Pembrolizumab Combination Therapy Cohorts – Advanced
Non-small Cell Lung Cancer (NSCLC)
-To evaluate the safety and tolerability
of AMG 510 in combination with
pembrolizumab in adult subjects with
KRAS p.G12C mutant advanced
NSCLC."Phase 1 Part 2e Previously Untreated Metastatic NSCLC Monotherapy Cohort (QD)
- To evaluate the safety and tolerability
of AMG 510 in adult subjects with
previously untreated, KRAS p.G12C
mutant metastatic NSCLC
- To evaluate tumor response assessed
by Response Evaluation Criteria in
Solid Tumors (RECIST) 1.1 of
AMG 510 as monotherapy in adult
subjects with previously untreated
KRAS p.G12C mutant metastatic
NSCLC.Phase 2 Part A – NSCLC, CRC, and other tumor types
(AMG 510 monotherapy)
-To evaluate tumor objective response
rate (ORR) assessed by RECIST 1.1
criteria of AMG 510 as monotherapy in
subjects with KRAS p.G12C mutated
advanced tumors (NSCLC, colorectal
cancer [CRC], and other tumor types).Phase 2 Part B – NSCLC (Dose Comparison Study)
-To evaluate tumor objective response
rate (ORR) assessed by RECIST 1.1
criteria of AMG 510 960 mg QD and 240
mg QD as monotherapy in previously
treated subjects with KRAS p.G12C
mutated advanced NSCLC
-To evaluate the safety and tolerability of
AMG 510 960 mg QD and 240 mg QD in
previously treated subjects with
KRAS p.G12C-mutated advanced
NSCLC.
Secondary objectives 5
- Phase 1 Part 1a and Part 2a Monotherapy Cohorts (QD) – Advanced Solid Tumors Phase 1 Part 1b and Part 2b Monotherapy Cohorts (BID) – Advanced Solid Tumors Phase 1 Part 1d and Part 2d Monotherapy Cohorts (QD) – Advanced Solid Tumors (Fed State) -To characterize the pharmacokinetics (PK) of AMG 510 following administration as an oral tablet formulation - To evaluate tumor response assessed by response evaluation criteria in advanced solid tumors (RECIST) 1.1 of AMG 510 as monotherapy in advanced solid tumors with KRAS p.G12C mutation - To evaluate the effect of food on the oral PK of AMG 510 -To evaluate the relationship between changes in corrected QT interval (QTc) and AMG 510 exposure (Part 1a and Part 2a only)
- Phase 1 Part 1c and Part 2c Pembrolizumab Combination Therapy Cohorts – Advanced NSCLC -To characterize the PK of AMG 510 following administration as an oral tablet formulation in combination with pembrolizumab -To evaluate tumor response assessed by RECIST 1.1 and other measures of efficacy of AMG 510 in combination with pembrolizumab in adult subjects with KRAS p.G12C mutant advanced NSCLC
- Phase 1 Part 2e Previously Untreated Metastatic NSCLC Monotherapy Cohort (QD) - To characterize the PK of AMG 510 following administration as an oral tablet formulation - To evaluate the PK of midazolam when administered with and without AMG 510 (substudy of Part 2e only) - To evaluate efficacy of AMG 510 as monotherapy by OS in adult subjects with previously untreated KRAS p.G12C mutant metastatic NSCLC - To evaluate efficacy of AMG 510 as monotherapy by PFS in adult subjects with previously untreated KRAS p.G12C mutant metastatic NSCLC
- Phase 2 Part A – NSCLC, colorectal cancer (CRC), and other tumor types (AMG 510 monotherapy) - To evaluate other measures of AMG 510 efficacy as monotherapy in subject with KRAS p.G12C mutant advanced tumors by RECIST 1.1 (NSCLC, CRC, and other tumor types) -To evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors (NSCLC, CRC, and other tumor types) -To evaluate the PK of AMG 510 following administration as an oral tablet formulation
- Phase 2 Part B – NSCLC (Dose Comparison Study) - To evaluate other measures of AMG 510 efficacy at 960 mg QD and 240 mg QD in previously treated subjects with KRAS p.G12C mutant advanced NSCLC by RECIST 1.1 -To evaluate the pharmacokinetics (PK) of AMG 510 following administration of 960 mg QD and 240 mg QD -To explore the subject experience with AMG 510 treatment using patient-reported outcome instruments
Conditions and MedDRA coding
KRAS p.G12C Mutant Advanced Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase 1 Part 1 - Dose Exploration Phase 1 is a first in human (FIH) dose exploration/expansion study.
The phase 1 portion of the study will be conducted in 2 parts. Part 1 is the Dose Exploration.
• Part 1a is aimed at evaluating the safety, tolerability, PK, and pharmacodynamics and determining the MTD of repeat daily (QD) dosing for AMG 510 monotherapy in subjects with KRAS p.G12C mutant advanced solid tumors using a Bayesian Logistics Regression Model (BLRM) design
• Part 1b is aimed at evaluating the safety, tolerability, PK, and pharmacodynamics of 480 mg twice daily (BID) dosing for AMG 510 monotherapy when administered with food in subjects with KRAS p.G12C mutant advanced solid tumors
• Part 1c is aimed at evaluating the safety, tolerability, and PK of AMG 510 QD in combination with pembrolizumab in subjects with KRAS p.G12C mutant advanced NSCLC.
• Part 1d is aimed at evaluating the safety, tolerability, PK, and pharmacodynamics of 960 mg QD dosing of AMG 510 monotherapy when administered with food in subjects with KRAS p.G12C mutant advanced solid tumors
|
Not Applicable | None | Phase 1 Part 2 - Dose Expansion: Upon completing the dose exploration part of the study and depending on data obtained, dose expansion may proceed with groups consisting of subjects with KRAS p.G12C mutant solid tumors: • Part 2a subjects with KRAS p.G12C mutant advanced NSCLC, CRC, or other tumor types administered 960 mg AMG 510 monotherapy QD (total approximately n = 20, maximum n = 60). • Part 2b subjects with KRAS p.G12C mutant advanced NSCLC, CRC, or other tumor types administered 480 mg AMG 510 monotherapy BID with food (total approximately n = 40) • Part 2c subjects with KRAS p.G12C mutant advanced NSCLC administered AMG 510 in combination with pembrolizumab (approximately n = 15). • Part 2d subjects with KRAS p.G12C mutant advanced NSCLC, CRC, or other tumor types administered 960 mg AMG 510 monotherapy once daily with food (total approximately n = 9) • Part 2e dose expansion cohort will be aimed at evaluating the safety, tolerability, preliminary efficacy, PK, and pharmacodynamics of 960 mg QD dosing for AMG 510 monotherapy in subjects with previously untreated KRAS p.G12C mutant advanced NSCLC. Dose expansion in these cohorts may be done concurrently. Phase 2 Part A: Phase 2 Part A is a multicenter, non-randomized, open-label study to evaluate efficacy and safety/tolerability of AMG 510 as monotherapy in subjects with KRAS p.G12C mutant advanced solid tumors (NSCLC, CRC, and other tumors). Phase 2 Part B: Phase 2 Part B is a multicenter, randomized, open-label study to evaluate the safety and efficacy of AMG 510 as monotherapy in subjects with previously treated locally advanced and unresectable or metastatic KRAS p.G12C mutant advanced NSCLC. Subjects will be randomized 1:1 to receive AMG 510 at 960 mg QD or 240 mg QD. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Men or women greater than or equal to 18 years old.
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.
Exclusion criteria 3
- Active brain metastases from non-brain tumors.
- Myocardial infarction within 6 months of study day 1.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 9
- Phase 1 Part 1a and Part 2a Monotherapy Cohorts: Incidence of treatment emergent adverse events, treatment-related adverse events, and clinically significant changes in vital signs, physical examinations, electrocardiograms (ECGs), and clinical laboratory tests
- Phase 1 Part 1a and Part 2a Monotherapy Cohorts: Incidence of dose-limiting toxicity (DLT)
- Phase 1 Part 1b and Part 2b Monotherapy Cohorts and Phase 1 Part 1d and Part 2d Monotherapy Cohorts: Incidence of DLTs, treatment emergent adverse events, treatment-related adverse events, and changes in vital signs, ECGs, and clinical laboratory tests
- Phase 1 Part 1c and Part 2c Pembrolizumab Combination Therapy Cohorts: Incidence of DLTs, treatment emergent adverse events, treatment-related adverse events, and clinically significant changes in vital signs, physical examinations, ECGs, and clinical laboratory tests
- Phase 1 Part 2e Previously Untreated Metastatic NSCLC Monotherapy Cohort: Incidence of DLTs, treatment emergent adverse events, treatment-related adverse events, and changes in vital signs, ECGs, and clinical laboratory tests
- Phase 1 Part 2e Previously Untreated Metastatic NSCLC Monotherapy Cohort: Objective response (OR = complete response [CR] + partial response [PR]), duration of response (DOR), disease control (CR + PR + stable disease [SD]), duration of SD, and time to response measured by CT or MRI and assessed per RECIST 1.1. Response will be assessed by BICR. CR and PR require confirmatory CT or MRI repeat assessment at least 4 weeks after the first detection of response.
- Phase 2 Part A – NSCLC, CRC, and other tumor types (AMG 510 monotherapy): Objective response (OR = CR + PR), measured by CT or MRI and assessed per RECIST 1.1. Response will be assessed by BICR. Complete response and PR require confirmatory CT or MRI repeat assessment at least 4 weeks after the first detection of response.
- Phase 2 Part B – NSCLC (Dose Comparison Study): Objective response (ORR = CR + PR), measured by CT or MRI and assessed per RECIST 1.1. Response will be assessed by BICR. Complete response and PR require confirmatory CT or MRI repeat assessment at least 4 weeks after the first detection of response.
- Phase 2 Part B – NSCLC (Dose Comparison Study): Treatment emergent adverse events (TEAE), grade greater/equal to 3 TEAE, serious adverse event (SAEs), and events of interest (EOIs)
Secondary endpoints 19
- Phase 1 Part 1a and Part 2a Monotherapy Cohorts (QD), Phase 1 Part 1b and Part 2b Monotherapy Cohorts (BID), and Phase 1 Part 1d and Part 2d Monotherapy Cohorts (QD): PK parameters of AMG 510 including, but not limited to, maximum plasma concentration (Cmax), time to achieve Cmax (tmax), and area under the plasma concentration-time curve (AUC)
- Phase 1 Part 1a and Part 2a Monotherapy Cohorts (QD), Phase 1 Part 1b and Part 2b Monotherapy Cohorts (BID), and Phase 1 Part 1d and Part 2d Monotherapy Cohorts (QD): OR, DOR, disease control, progression free survival (PFS), duration of stable disease, and TTR measured by CT or MRI and assessed per RECIST 1.1. Response will be assessed by BICR. Complete response and PR require confirmatory CT or MRI repeat assessment at least 4 weeks after the first detection of response.
- Phase 1 Part 1a and Part 2a Monotherapy Cohorts (QD), Phase 1 Part 1b and Part 2b Monotherapy Cohorts (BID), and Phase 1 Part 1d and Part 2d Monotherapy Cohorts (QD): Overall survival (OS)
- Phase 1 Part 1a and Part 2a Monotherapy Cohorts (QD), Phase 1 Part 1b and Part 2b Monotherapy Cohorts (BID), and Phase 1 Part 1d and Part 2d Monotherapy Cohorts (QD): PK parameters of AMG 510 including, but not limited to, Cmax, tmax, and AUC in the fed and/or fasted state
- Phase 1 Part 1a and Part 2a Monotherapy Cohorts (QD), Phase 1 Part 1b and Part 2b Monotherapy Cohorts (BID), and Phase 1 Part 1d and Part 2d Monotherapy Cohorts (QD): AMG 510 exposure/QTc interval relationship
- Phase 1 Part 1c and Part 2c Pembrolizumab Combination Therapy Cohorts: PK parameters of AMG 510 including, but not limited to, Cmax, tmax, and AUC
- Phase 1 Part 1c and Part 2c Pembrolizumab Combination Therapy Cohorts: OR, DOR, disease control, PFS, duration of stable disease, and TTR measured by CT or MRI and assessed per RECIST 1.1. Response will be assessed by BICR. Complete response and PR require confirmatory CT or MRI repeat assessment at least 4 weeks after the first detection of response.
- Phase 1 Part 1c and Part 2c Pembrolizumab Combination Therapy Cohorts: OS
- Phase 1 Part 2e Previously Untreated Metastatic NSCLC Monotherapy Cohort: PK parameters of AMG 510 including, but not limited to Cmax, tmax, and AUC
- Phase 1 Part 2e Previously Untreated Metastatic NSCLC Monotherapy Cohort: PK parameters for midazolam including, but not limited to: Cmax, AUC, clearance, and t1/2
- Phase 1 Part 2e Previously Untreated Metastatic NSCLC Monotherapy Cohort: - OS - PFS
- Phase 2 Part A – NSCLC, CRC, and other tumor types (AMG 510 monotherapy): - Duration of response (DOR) - Disease control - Time to response (TTR) - Progression-free survival (PFS) - Overall survival (OS) - 6-month PFS and 12 month PFS - 12 month OS
- Phase 2 Part A – NSCLC, CRC, and other tumor types (AMG 510 monotherapy): Incidence and severity of adverse events
- Phase 2 Part A – NSCLC, CRC, and other tumor types (AMG 510 monotherapy): PK parameters of AMG 510 including, but not limited to, Cmax, tmax, and AUC
- Phase 2 Part B – NSCLC (Dose Comparison Study): - Duration of response (DOR) - Disease control (DCR = CR + PR + SD) - Depth of response (best percent change from baseline in lesion sum diameters) - Time to response (TTR) - Progression free survival (PFS) - Overall survival (OS)
- Phase 2 Part B – NSCLC (Dose Comparison Study): PK parameters of AMG 510 including, but not limited to, Cmax and AUC
- Phase 2 Part B – NSCLC: Changes in cancer-specific symptoms and overall health status using subject reported outcome instruments: Impact of treatment on disease related symptoms and HRQOL (instruments; EORTC QLQ C30 + disease-specific modules QLQ LC13 and NSCLC SAQ for NSCLC; PGIS and PGIC in cough, dyspnea and chest pain among NSCLC subjects). (cont.)
- Phase 2 Part B – NSCLC: (cont. from prev. point) Treatment-related symptoms and impact on the subject (EORTC QLQ C30, selected questions from the PRO-CTCAE library and a single item about symptom bother, item GP5 of the FACT-G).
- Phase 2 Part B – NSCLC (Dose Comparison Study): Physical function (instrument: EORTC QLQ-C30, Physical function scale)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB197397 · Substance
- Active substance
- Sotorasib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Please refer to the sotorasib IMPD-Q enclosed with the application
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1730
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Other, Data management |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Neogenomics Laboratories Inc. ORG-100041804
|
Houston, United States | Other |
| Rad Md LLC ORG-100044816
|
Conshohocken, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Excelya Greece CRO Single Member S.A. ORG-100009224
|
Vrilissia, Greece | On site monitoring |
Locations
8 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 36 | 4 |
| Belgium | Ended | 88 | 3 |
| France | Ended | 40 | 1 |
| Greece | Ongoing, recruitment ended | 20 | 1 |
| Hungary | Ended | 16 | 1 |
| Portugal | Ended | 9 | 1 |
| Romania | Ended | 10 | 1 |
| Spain | Ended | 27 | 2 |
| Rest of world
Switzerland, United States, Brazil, Australia, Japan, Korea, Republic of, Canada
|
— | 686 | — |
Investigational sites
Medical University Of Vienna
Department of Internal Medicine I, Division of Clinical Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
Krankenhaus Nord Klinik Floridsdorf
Department of Internal Medicine and Pneumology, Bruenner Strasse 68, Floridsdorf, Vienna
Universitaetsklinikum Krems
Division of Pneumology, Mitterweg 10, 3500, Krems An Der Donau
Medical University Of Graz
Department of Internal Medicine, Neue Stiftingtalstrasse 6, 8010, Graz
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
UZ Leuven
Respiratory Oncology, Herestraat 49, 3000, Leuven
Henry Dunant Hospital Center
4th Oncology Department and Clinical Trials Unit, 107 Mesogeion Avenue, 115 26, Athens
Toeroekbalinti Tuedogyogyintezet
Onko-pulmonologiai es jarobetegellato Centrum, Munkacsy Mihaly Utca 70, 2045, Torokbalint
Unidade Local De Saude De Santa Maria E.P.E.
Hospital de Dia de Pneumologia Oncologica, Alameda Das Linhas De Torres No 117, 1769-001, Lisbon
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
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 |
|---|---|---|---|---|---|
| Austria | 2019-11-05 | 2026-05-12 | 2019-11-19 | 2022-09-02 | |
| Belgium | 2019-09-04 | 2025-07-29 | 2019-09-12 | 2022-09-02 | |
| France | 2019-05-31 | 2024-04-23 | 2019-06-13 | 2022-09-02 | |
| Greece | 2021-08-03 | 2021-08-19 | 2022-09-02 | ||
| Hungary | 2021-09-24 | 2025-10-15 | 2021-10-21 | 2022-09-02 | |
| Portugal | 2021-10-27 | 2024-02-22 | 2021-10-28 | 2022-09-02 | |
| Romania | 2021-10-20 | 2024-04-23 | 2021-10-21 | 2022-09-02 | |
| Spain | 2021-10-07 | 2026-05-12 | 2021-11-18 | 2022-09-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 87 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | CSR_Full Interim Analysis Protocol_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Full Interim Analysis Report_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Full Interim Analysis Sample CRF_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Full Interim Analysis Statistical Methods_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Full Interim Analysis Synopsis_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Supplemental Interim Analysis Protocol_Apr 2023_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Supplemental Interim Analysis Protocol_Aug 2023_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Supplemental Interim Analysis Protocol_Feb 2021_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Supplemental Interim Analysis Report_Apr 2023_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Supplemental Interim Analysis Report_Aug 2023_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Supplemental Interim Analysis Report_Feb 2021_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Supplemental Interim Analysis Synopsis_Apr 2023_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Supplemental Interim Analysis Synopsis_Aug 2023_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Supplemental Interim Analysis Synopsis_Feb 2021_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Synopsis Interim Analysis Protocol_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Synopsis Interim Analysis Report_2024-511798-31_For Publication | 1 |
| Clinical study report (for publication) | CSR_Synopsis Interim Analysis Synopsis_2024-511798-31_For Publication | 1 |
| Protocol (for publication) | D1_Protocol_ENG_2024-511798-31_20170543_FP | 10 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Dummy document_FP | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_For publication | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_FP | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrengements_For Publication | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Thank You Letter | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Addendum Alternative Visit Procedures during COVID-19 Management | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Home Healthcare Service and Direct to Patient process | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Local Lab changes | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Alternative Visit Procedure_Eng_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Alternative Visit procedure_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Alternative Visit Procedure_Translation_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Clincard_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_For publication | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_FP_Clean | 15.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research_FP_Clean | 15.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Home Healthcare Service and DtPS_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Home Healthcare Service_Eng_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Home Healthcare Service_Translation_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Informed Consent Procedure_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Local Lab Change_Eng_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Local Lab Change_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Local Lab Change_Translation_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Study_2A2B_FP_Clean | 16.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Study_2B_FP_Clean | 16.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Eng_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_For Publication | 15 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FP | 14.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Translation_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Opt tumor biopsy_For publication | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pharmacocinetics and ECG_For Publication | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pharmacogenetics_For Publication | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PK and ECG Research_FP_Clean | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant woman_For Publication | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF T continuation_For publication | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Continuation_FP_Clean | 15.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Tumor Biopsy_FP_Clean | 15.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Withdrawal_For publication | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum1_EN_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum1_FR_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum1_NL_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum2.1_EN_FP | 14.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum2.1_FR_FP | 14.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum2.1_NL_FP | 14.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum4.1_EN_FP | 14 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum4.1_FR_FP | 14 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum4.1_NL_FP | 14 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DE_FP | 15 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_EN_FP | 15 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR_FP | 15 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_NL_FP | 15 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening_EN_FP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening_FR_FP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening_NL_FP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum 1_FP | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum 2_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum 4_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_CTDP_FP | 10.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_FR AT_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 16.2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PG_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PK-ECG_FP | 14.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_TB_FP | 5.0 |
| Subject information and informed consent form (for publication) | L2_Inform Consent Procedure_For Publication | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Informed Consent Procedure_Dummy document_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Informed Consent Procedure AT_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed consent procedure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Notification to Study Participants of Transition to EU-CTR_FP | 1 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-26 | Austria | Acceptable 2024-04-18
|
2024-04-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-19 | Austria | Acceptable | 2024-07-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-14 | Acceptable | 2024-11-18 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-18 | Austria | 2024-11-18 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-20 | 2025-05-20 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-06-23 | Austria | Acceptable | 2025-08-04 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-06-25 | Acceptable | 2025-09-09 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-29 | Austria | Acceptable | 2025-09-29 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-10-23 | Austria | Acceptable | 2025-10-23 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-04-22 | Acceptable | 2026-06-03 |