Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
960
Countries
1
Sites
17
Unresectable locally advanced and/or metastatic soft-tissue sarcoma
In participants with advanced Soft-Tissue Sarcomas: to assess the feasibility of high throughput molecular analysis (next generation sequencing exome [NGS]). Primary objective will be assessed in participants randomized in the arm “NGS”. Feasibility will be defined as the proportion of participants for whom results fr…
Key facts
- Sponsor
- Institut National De La Sante Et De La Recherche Medicale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Oct 2019 → 20 Jan 2026
- Decision date (initial)
- 2024-10-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- 3rd Cancer Plan (2014-2019) · Plan for Personalized Genomic Medicine 2025
External identifiers
- EU CT number
- 2024-514873-22-00
- EudraCT number
- 2017-002851-27
- ClinicalTrials.gov
- NCT03784014
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Safety, Therapy, Efficacy
In participants with advanced Soft-Tissue Sarcomas: to assess the feasibility of high throughput molecular analysis (next generation sequencing exome [NGS]).
Primary objective will be assessed in participants randomized in the arm “NGS”.
Feasibility will be defined as the proportion of participants for whom results from NGS are (i) interpretable and (ii) for whom a validated report of exome sequencing including a clinical recommendation from the molecular tumor board is available within 7 weeks (i.e. at most 49 calendar days) after reception of blood and tumor samples by one of the molecular platform.
Secondary objectives 9
- Comparison of the efficacy of the 2 treatment strategies (NGS vs No NGS) in terms of : Progression-free survival (median PFS, PFS after 1 and 2-year follow-up), Overall survival (median OS, OS after 1 and 2-year follow-up).
- Feasibility of NGS, Proportion of participants with interpretable NGS results, Delay from the date of signature of the informed consent to the date of the molecular tumor board.
- In participants with advanced STS, Proportion of participants presenting at least one targetable genomic alteration.
- Efficacy of first-line systemic treatment (in all participants) terms of: Progression-free survival (median PFS, PFS rate after 1- and 2-year follow-up), Overall survival (median OS, OS rate after 1- and 2-year follow-up), Best overall response under first-line treatment, 6-month objective response under first-line treatment, 6-month non progression rate, Exploratory analyses: prognostic value of genomic alteration (any) on the PFS and OS of first-line treatment AND association between the presence of targetable genomic alteration and response to first-line treatment
- Efficacy and safety profile of each targeted treatment 6-month non progression rate Progression-free survival (median PFS, 1-year PFS rate) Overall survival (median OS, 1-year OS rate) Best overall response under treatment Objective response under treatment Change in tumor size Safety as per CTC AE v5.0.
- To estimate the cost-effectiveness of the strategy using NGS as compared to the strategy without NGS. This objective will be assessed in all randomized patients The outcome will be the incremental cost-utility ratio or the incremental cost per incremental Quality Adjusted Life Year (QALY). Subgroup analyses: (i) responders to first-line chemotherapy and (ii) non-responders to first-line chemotherapy
- Impact of the result of immunosequencing on objective response (OR), progression-free survival (PFS) and overall survival (OS).
- Assessment of the feasibility of NGS in participants who have switched treatment arm for NGS arm in terms of: Proportion of participants with interpretable NGS results For participants with interpretable NGS results: delay from the date of treatment failure (progression, investigator decision, end of last treatment line) to the date of the molecular tumor board Proportion of participants presenting at least one targetable genomic alteration.
- Exploratory objectives : For those participants initially randomized in the Arm “No NGS”, as well as for those participants randomized in the Arm “No NGS” and who did not cross-over to the Arm “NGS” : NGS will be performed for all participants in order to asses : The feasibility of high throughput molecular analysis NGS (exome, RNASeq) in terms of additional feasibility endpoints (secondary objective n°2 above), Assessment of the proportion of participants with advanced STS presenting at least one targetable genomic alteration (secondary objective n°3 above), The prognostic value of genomic alteration (any) on the efficacy (PFS and OS) of first-line systemic treatment (in all participants), Association between the presence of targetable genomic alteration and response to first-line systemic treatment. For those patients with an initial amount of nucleic acid that was too low for sequencing (<250 ng but ≥ 125 ng): NGS will be perfomed using a modified library preparation protocol. This novel approach will allow to retrieve valuable NGS information.
Conditions and MedDRA coding
Unresectable locally advanced and/or metastatic soft-tissue sarcoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 20.0 | LLT | 10039494 | Sarcoma NOS | 10029104 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Master protocol MULTISARC is a randomized multicenter study assessing whether high throughput molecular analysis (next generation sequencing exome - NGS) is feasible in advanced soft tissue sarcoma participants, that is, whether NGS can be conducted for a large proportion of participants, with results available within reasonable delays (see primary endpoint).
|
Randomised Controlled | None | NGS: For participants randomized in Arm NGS, disease will be treated as per standard care with a first-line systemic treatment (please refer to current SmPC http://base-donnees-publique.medicaments.gouv.fr for treatment management) and tumor evaluation will be performed every 2 cycles. At the end of first-line systemic treatment and regardless of tumor response as per RECIST v1.1, participants will be discussed within a multidisciplinary tumor board (molecular tumor board-MTB) which aims at discussing the genomic profiles and at providing a therapeutic decision for each participant. This MTB involves clinical oncologists, pathologists and biologists. No NGS: For participants randomized in Arm No NGS, disease will be treated as per standard care with a first-line systemic treatment (please refer to current SmPC http://base-donnees-publique.medicaments.gouv.fr for treatment management) and tumor evaluation will be performed every 2 cycles. Thereafter, they will be managed as per standard care and will be followed up until death or study discontinuation whichever occurs first. For these participants, treatments regimen, tumor response during and/or after treatment, survival follow-up will be collected on study database. |
|
| 2 | Sub-trails protocol For participants randomized in Arm NGS, after first-line systemic treatment and regardless of tumor response as per RECIST v1.1, participants will be discussed within a multidisciplinary tumor board (molecular tumor board-MTB) which aims at discussing the genomic profiles and at providing a therapeutic decision for each participant. This MTB involves clinical oncologists, pathologists, molecular biologists, and bio-informaticians.
Participants for whom a targetable genomic alteration (i.e. genomic alteration that can be targeted by one of the drug available in the present study) has been identified will be proposed to enter in one of the subsequent phase II single-arm sub-trial.
|
Not Applicable | None | Nilotinib: Unresectable locally advanced and/or metastatic soft tissue sarcoma participants, previously treated by first-line regimen and for whom a molecular alteration can be targeted by Nilotinib in a single-arm phase II sub-trial. Ceritinib: Unresectable locally advanced and/or metastatic soft tissue sarcoma participants, previously treated by first-line regimen and for whom a molecular alteration can be targeted by Ceritinib in a single-arm phase II sub-trial. Capmatinib: Unresectable locally advanced and/or metastatic soft tissue sarcoma participants, previously treated by first-line regimen and for whom a molecular alteration can be targeted by Capmatinib in a single-arm phase II sub-trial. Lapatinib: Unresectable locally advanced and/or metastatic soft tissue sarcoma participants, previously treated by first-line regimen and for whom a molecular alteration can be targeted by Lapatinib in a single-arm phase II sub-trial. Trametinib: Unresectable locally advanced and/or metastatic soft tissue sarcoma participants, previously treated by first-line regimen and for whom a molecular alteration can be targeted by Trametinib in a single-arm phase II sub-trial. Trametinib and Dabrafenib: Unresectable locally advanced and/or metastatic soft tissue sarcoma participants, previously treated by first-line regimen and for whom a molecular alteration can be targeted by Trametinib + Dabrafenib in a single-arm phase II sub-trial. Olaparib and Durvalumab: Unresectable locally advanced and/or metastatic soft tissue sarcoma participants, previously treated by first-line regimen and for whom a molecular alteration can be targeted by Olaparib + Durvalumab in a single-arm phase II sub-trial. Palbociclib: Unresectable locally advanced and/or metastatic soft tissue sarcoma participants, previously treated by first-line regimen and for whom a molecular alteration can be targeted by Palbociclib in a single-arm phase II sub-trial. Glasdegib: Unresectable locally advanced and/or metastatic soft tissue sarcoma participants, previously treated by first-line regimen and for whom a molecular alteration can be targeted by Glasdegib in a single-arm phase II sub-trial. Futibatinib: Unresectable locally advanced and/or metastatic soft tissue sarcoma participants, previously treated by first-line regimen and for whom a molecular alteration can be targeted by TAS-120 in a single-arm phase II sub-trial. |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Data from the MULTISARC study will be integrated into the Data Collector and Analyzer (CAD) provided for the Plan for Personalized Genomic Medicine 2025, where they will be stored for use in diagnostic and prognostic decision support, the development of therapeutic strategies, and health-related research, studies and evaluations. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of scientific and ethic commitee of the CAD.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-503665-39-00 | Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements | Taiho Oncology Inc. |
| 2024-511142-39-00 | A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy. | AstraZeneca AB |
| 2023-510015-19-00 | A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer | AstraZeneca AB |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 13
- Age ≥ 18 years
- Histology: soft-tissue sarcoma confirmed by the RRePS Network, as recommended by the French NCI
- Unresectable locally advanced and/or metastatic STS
- No previous systemic treatment for advanced disease
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Adequate hematological and metabolic functions: 1. Hemoglobin > 9 g/dL, 2. Albumin > 30 g/L.
- Measurable disease according to RECIST 1.1. At least one site of disease must be uni-dimensionally > 10 mm.
- Availability of suitable frozen archive tumor material from a metastatic lesion or advanced disease (not previously treated), or at least one lesion that can be biopsied for research purpose.
- Archived FFPE block of specimen tumor sampling obtained anytime during disease development for research purpose.
- Eligible to first-line systemic treatment
- No prior or concurrent malignant disease diagnosed or treated in the last two years before inclusion. Note that patients with in situ carcinoma of the cervix, or adequately treated basal cell or squamous cell carcinoma of the skin, or adequately treated localized prostate cancer, or other localized cancer under maintenance therapy can be included as long as they don't limit assessment of efficacy of first-line systemic therapy.
- Participant with a social security in compliance with the French law.
- Voluntary signed and dated written informed consent prior to any study specific procedure (ICF1).
Exclusion criteria 11
- Radiological evidence of symptomatic or progressive brain metastases.
- Inability to swallow.
- Major problem with intestinal absorption.
- Previous allogeneic bone marrow transplant.
- Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV or active autoimmune disease).
- Any condition which in the Investigator’s opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
- ndividuals deprived of liberty or placed under guardianship.
- Pregnant or breast feeding women.
- Men or women refusing contraception.
- Previous enrolment in the present study.
- Any contraindication to first-line systemic treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Feasibility next generation sequencing exome : NGS (exome) for the primary objective will be considered feasible if (i) NGS results are available and interpretable, and (ii) a report of exome sequencing including a clinical recommendation from a molecular tumor board is provided to investigators within 7 weeks (i.e. at most 49 calendar days) from reception of the samples (blood and tumor samples) by one of the MULTIPLI platforms.
Secondary endpoints 11
- Overall survival (OS): OS for the secondary objective is defined as the delay from the date of randomization to the date of death. OS for the assessment of efficacy of first-line treatment: OS will be defined as the delay from the date of onset of first-line treatment to the date of death. OS for the assessment of efficacy of targeted treatment: OS will be defined as the delay from the date of onset of targeted treatment to the date of death.
- Progression-free survival (PFS) for the secondary objective is defined as the delay from the date of randomization to the date of progression as per RECIST v1.1. or death, whichever occurs first. PFS for the assessment of efficacy of first-line treatment and the targeted treatment: PFS will be defined as the delay from the date of onset of first-line or targeted treatment to the date of progression as per RECIST v1.1. or death, whichever occurs first.
- Participants with targetable alteration(s) A participant will be considered as “presenting at least one targetable genomic alteration”, if the MTB consider that at least one genomic alteration identified can be matched with one of the drug available through the MULTISARC study.
- Best overall response for the assessment of efficacy of first-line treatment: Best response will be recorded from the date of onset of first-line treatment taking into account any requirement for confirmation as per RECIST 1.1 criteria. Best overall response under treatment for the assessment of efficacy of targeted treatment: Best response will be recorded from the date of onset of targeted treatment taking into account any requirement for confirmation as per RECIST 1.1 criteria.
- Objective response under treatment is defined as complete or partial response (CR, PR) as per RECIST v1.1 under first-line treatment. ). Following RECIST v1.1 recommendations, each participant will be assigned one of the following categories: complete response, partial response, stable disease, progression, invaluable for response. Moreover, claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
- For the assessment of efficacy of first-line treatment and targeted treatment: Non-progression at 6 months is defined as complete or partial response (CR, PR) or stable disease (SD) at 6 months as per RECIST v1.1 under first-line or targeted treatment. Claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
- Change in tumor size is defined as the difference (in percentage) in tumor size burden from the date of targeted treatment initiation (baseline) to the tumor assessment.
- Immunosequencing: Correlation of TCR-sequencing data with objective response (OR), progression-free survival (PFS) and Evaluate the association between immune profiles derived from ancillary analyses (VISIUM HD, multiplex IF, SomaScan proteomics) and treatment response, within an integrated immunosequencing framework. and overall survival (OS).
- Real cost of NGS: Micro-costing studies collect detailed data on resources utilized and the value of those resources. Cost of other resources: The French National Health Insurance reimburses the vast majority of other resources involved in the care of patients in this trial. These costs will be extracted from the French National Health Insurance data, and cost Per diem allowances: In case of sick leave.
- Utility data and Quality Adjusted Life Years Utility scores will be assessed through the EuroQol-5D-5L questionnaire. A Quality Adjusted Life Year is the survival (in years) weighted by a utility score.
- Incremental cost utility ratio: Our incremental cost-utility ratio is difference in cost between both strategies (NGS and no NGS) divided by the difference in QALYs.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 19
Tyverb 250 mg film-coated tablets
PRD3045791 · Product
- Active substance
- Lapatinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 42000 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EH01 — -
- Marketing authorisation
- EU/1/07/440/006
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6503927 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 2625 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/003
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6503996 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 2625 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/005
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6503929 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 2625 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651398 · Product
- Active substance
- Durvalumab
- Substance synonyms
- MEDI4736
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF03 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lytgobi 4 mg film-coated tablets
PRD10572480 · Product
- Active substance
- Futibatinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 420 mg milligram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EN04 — -
- Marketing authorisation
- EU/1/23/1741/001
- MA holder
- TAIHO PHARMA NETHERLANDS B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9585495 · Product
- Active substance
- Futibatinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 420 mg milligram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- TAIHO ONCOLOGY, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD2749296 · Product
- Active substance
- Ceritinib
- Substance synonyms
- LDK378, 5-CHLORO-N2-[2-ISOPROPOXY-5-METHYL-4-(4-PIPERIDINYL)PHENYL]-N4-[2-(ISOPROPYLSULFONYL)PHENYL]-2,4-PYRIMIDINEDIAMINE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 450 mg milligram(s)
- Max total dose
- 12.6 g gram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01ED02 — -
- Marketing authorisation
- EU/1/15/999/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tabrecta 200 mg film-coated tablets
PRD9779744 · Product
- Active substance
- Capmatinib
- Substance synonyms
- INC280, 2-FLUORO-N-METHYL-4-(7-(QUINOLIN-6-YLMETHYL)IMIDAZO(1,2-B)(1,2,4)TRIAZIN-2-YL)BENZAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 22.4 g gram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EX17 — -
- Marketing authorisation
- EU/1/22/1650/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tabrecta 150 mg film-coated tablets
PRD9779736 · Product
- Active substance
- Capmatinib
- Substance synonyms
- INC280, 2-FLUORO-N-METHYL-4-(7-(QUINOLIN-6-YLMETHYL)IMIDAZO(1,2-B)(1,2,4)TRIAZIN-2-YL)BENZAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 22.4 g gram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EX17 — -
- Marketing authorisation
- EU/1/22/1650/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3045797 · Product
- Active substance
- Dabrafenib
- Substance synonyms
- GSK2118436
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 8.4 g gram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EC02 — -
- Marketing authorisation
- EU/1/13/865/004
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3045784 · Product
- Active substance
- Dabrafenib
- Substance synonyms
- GSK2118436
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 8.4 g gram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EC02 — -
- Marketing authorisation
- EU/1/13/865/002
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4009417 · Product
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 22.4 g gram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EA03 — -
- Marketing authorisation
- EU/1/07/422/007
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lynparza 150 mg film-coated tablets
PRD6152224 · Product
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 16.8 g gram(s)
- Max treatment duration
- 28 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
- No
- Modified vs. Marketing Authorisation
- No
Lynparza 100 mg film-coated tablets
PRD6163466 · Product
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 16.8 g gram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XX46 — -
- Marketing authorisation
- EU/1/14/959/003
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mekinist 0.5 mg film-coated tablets
PRD3045763 · Product
- Active substance
- Trametinib
- Substance synonyms
- GSK1120212B
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 56 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EE01 — -
- Marketing authorisation
- EU/1/14/931/002
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mekinist 2 mg film-coated tablets
PRD3045800 · Product
- Active substance
- Trametinib
- Substance synonyms
- GSK1120212B
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 52 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EE01 — -
- Marketing authorisation
- EU/1/14/931/006
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Daurismo 25 mg film-coated tablets
PRD8158002 · Product
- Active substance
- Glasdegib
- Substance synonyms
- PF-04449913
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 8.4 g gram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XJ03 — -
- Marketing authorisation
- EU/1/20/1451/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Daurismo 100 mg film-coated tablets
PRD8158035 · Product
- Active substance
- Glasdegib
- Substance synonyms
- PF-04449913
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 8.4 g gram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XJ03 — -
- Marketing authorisation
- EU/1/20/1451/003
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut National De La Sante Et De La Recherche Medicale
- Sponsor organisation
- Institut National De La Sante Et De La Recherche Medicale
- Address
- 101 Rue De Tolbiac
- City
- Paris Cedex 13
- Postcode
- 75654
- Country
- France
Scientific contact point
- Organisation
- Institut National De La Sante Et De La Recherche Medicale
- Contact name
- Antoine ITALIANO, MD, PhD
Public contact point
- Organisation
- Institut National De La Sante Et De La Recherche Medicale
- Contact name
- Christelle DELMAS
Locations
1 EU/EEA country · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 960 | 17 |
| Rest of world | — | 0 | — |
Investigational sites
Oncopole Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Gustave Roussy
Medical Oncology, 39 Rue Camille Desmoulins, 94805, Villejuif Cedex
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Paoli Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Poitiers
Medical Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Henri Becquerel
Medical Oncology, 1 Rue D Amiens, 76000, Rouen
Institut Curie
Medical Oncology, 26 Rue D Ulm, 75005, Paris
Assistance Publique Hopitaux De Paris
Medical Oncology, 43 Boulevard De L Hopital, 75013, Paris
Institut De Cancerologie Strasbourg Europe
Medico-Surgical Oncology & hematology, 17 Rue Albert Calmette, 67200, Strasbourg
Centre De Lutte Contre Le Cancer Eugene Marquis
Medical Oncology, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Assistance Publique Hopitaux De Paris
Oncology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Antoine Lacassagne
Medical Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Jean Perrin
Medical Oncology, 58 Rue Montalembert, 63011, Clermont Ferrand Cedex1
Centre Oscar Lambret
General oncology, 3 Rue Frederic Combemale, 59000, Lille
Centre Georges-François Leclerc
Medical Oncology, 1 rue du Pr Marion, 21000, Dijon
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 |
|---|---|---|---|---|---|
| France | 2019-10-16 | 2026-01-20 | 2019-10-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 32 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol SoC 2024-514873-22-00 | 2.0 |
| Protocol (for publication) | D1_ Protocol SoC TC 2024-514873-22-00 | 2.0 |
| Protocol (for publication) | D1_Protocol 2024-514873-22-00 | 10.0 |
| Protocol (for publication) | D1_Protocol appendices 2024-514873-22-00 | 10.0 |
| Protocol (for publication) | D1_Protocol Appendices TC_2024-514873-22-00 | 10.0 |
| Protocol (for publication) | D1_Protocol TC_2024-514873-22-00 | 10.0 |
| Protocol (for publication) | D1_Protocol_2024-514873-22-00 | 10.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements 2024-514873-22-00 | 1 |
| Subject information and informed consent form (for publication) | L1_ICf CAPMATINIB 2024-514873-22-00 | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF CERITINIB 2024-514873-22-00 | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF GLASDEGIB 2024-514873-22-00 | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF LAPATINIB 2024-514873-22-00 | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF NILOTINIB 2024-514873-22-00 | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF OLAPARIB DURVALUMAB 2024-514873-22-00 | 8.0 |
| Subject information and informed consent form (for publication) | L1_ICF PALBOCICLIB 2024-514873-22-00 | 6.0 |
| Subject information and informed consent form (for publication) | L1_ICF Prinicpale Stud2024-514873-22-00 | 6.0 |
| Subject information and informed consent form (for publication) | L1_ICF TRAMETINIB 2024-514873-22-00 | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF TRAMETINIB DABRAFENIB 2024-514873-22-00 | 6.0 |
| Subject information and informed consent form (for publication) | L1_TAS-120 2024-514873-22-00 | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Glasdegib_2024-514873-22-00 | 11.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lapatinib 2024-514873-22-00 | 22.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC non available_ Futibatinib TAS 1202024-514873-22-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Palbociclib_ 2024-514873-22-00 | 16.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Capmatinib_ 2024-514873-22-00 | 15 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ceritinib_ 2024-514873-22-00 | 15 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dabrafenib_ 2024-514873-22-00 | 16.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Durvalumab 2024-514873-22-00 | 19.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Nilotinib_2024-514873-22-00 | 18.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_OLAPARIB 2024-514873-22-00 | 22.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Trametinib_2024-514873-22-00 | 16.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-514873-22-00 | 10 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-514873-22-00_V10_14052025_TC_C16-40 | 10 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-13 | France | Acceptable 2024-10-03
|
2024-10-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-04 | France | Acceptable 2025-10-13
|
2025-10-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-26 | France | Acceptable 2025-10-13
|
2025-11-26 |