Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
267
Countries
5
Sites
41
Lung Cancer
To evaluate the safety and tolerability of RMC6291 in combination with pembrolizumab, with or without RMC-6236, with or without chemotherapy, in patients with advanced RAS G12C-mutated solid tumors To define the RP2DS for RMC-6291 in combination with pembrolizumab, with or without RMC-6236, with or without chemotherap…
Key facts
- Sponsor
- Revolution Medicines Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 17 Jul 2024 → ongoing
- Decision date (initial)
- 2024-06-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Revolution Medicines Inc
External identifiers
- EU CT number
- 2023-509571-16-00
- ClinicalTrials.gov
- NCT06162221
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Dose response
To evaluate the safety and tolerability of RMC6291 in combination with pembrolizumab, with or without RMC-6236, with or without chemotherapy, in patients with advanced RAS G12C-mutated solid tumors
To define the RP2DS for RMC-6291 in combination with pembrolizumab, with or without RMC-6236, with or without chemotherapy, in patients with advanced RAS G12C-mutated NSCLC
Secondary objectives 3
- To characterize the plasma PK of RMC-6291 inNcombination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS G12C-mutated solid tumors.
- To characterize the plasma PK of RMC-6291 and blood PK of RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS G12C-mutated NSCLC.
- To evaluate preliminary antitumor activity of RMC-6291 in combination with pembrolizumab, with or without RMC-6236, with or without chemotherapy, in patients with advanced RAS G12C-mutated NSCLC
Conditions and MedDRA coding
Lung Cancer
| 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 1b/2 activity
|
2 | None |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-516063-89-00 | RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator’s Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) | Revolution Medicines Inc. |
| 2023-508178-27-00 | RMC-6291-101 Phase 1b, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRASG12C-Mutated Solid Tumors | Revolution Medicines Inc. |
| 2024-511548-19-00 | Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects with Advanced KRASG12C Mutant Solid Tumors | Revolution Medicines Inc. |
| 2023-509572-42-00 | A Phase 1b/2 Open-Label, Multicenter Study of RMC-6236 in Combination with Pembrolizumab with or without Chemotherapy, in Patients with RAS‑Mutated Non-Small Cell Lung Cancer (NSCLC) – Subprotocol B | Revolution Medicines Inc. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. ≥ 18 years of age and signed the Informed Consent Form (ICF) 2. Patients that have solid tumor with RAS-G12C. 3. Patients that have received prior cancer treatment or are not able to tolerate regular treatments. 4. Patients that have at least one tumor lesion (an area of abnormal tissue) that can be measured. 5. Patients that have adequate organ function (bone marrow, liver, kidney).
Exclusion criteria 1
- 1. Participants that have primary brain and spinal cord tumor. 2. Participants thathave gastrointestinal problems that may affect absorption of RMC-6291. 3. Participants thathad any major surgery in the last 4 weeks. 4. Participants thathave any other medical condition that may interfere with the study drugs. 5. Participants that have previously taken targeted therapy for KRAS mutation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • Incidence of DLTs (Part 1 and Part 2 Cohort A2, A3 and A4 safety lead-in only) •Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in laboratory test values, ECGs, and vital signs
Secondary endpoints 1
- RMC-6291 plasma concentrations overtime and PK parameters as applicable. RMC-6291 plasma and RMC-6236 blood concentration over time and PK parameters as applicable • ORR and DOR per RECIST v1.1
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 27
Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD9682730 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 2205259.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatin-Ebewe, 1 Mg/Ml, Koncentrat Do Sporządzania Roztworu Do Infuzji
PRD771236 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 19903
- MA holder
- EBEWE PHARMA
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD9682731 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 2205259.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 9.52 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323786 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 9.52 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323784 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 9.52 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323785 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 9.52 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9891840 · Product
- Active substance
- RMC-6291
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9891841 · Product
- Active substance
- RMC-6291
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 9 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
Pemetrexed STADA 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD7905952 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 166.6 mg/m2 milligram(s)/sq. meter
- Max total dose
- 500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- 99025.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion
PRD4287914 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 166.6 mg/m2 milligram(s)/sq. meter
- Max total dose
- 500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/001
- MA holder
- FRESENIUS KABI ONCOLOGY PLC.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion
PRD8139711 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 166.6 mg/m2 milligram(s)/sq. meter
- Max total dose
- 500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/001
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion
PRD4287595 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 166.6 mg/m2 milligram(s)/sq. meter
- Max total dose
- 500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/001
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Synthon 25 mg/ml, concentraat voor oplossing voor infusie
PRD5986697 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 166.6 mg/m2 milligram(s)/sq. meter
- Max total dose
- 500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- RVG 120309
- MA holder
- SYNTHON BV
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion
PRD8139709 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 166.6 mg/m2 milligram(s)/sq. meter
- Max total dose
- 500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/001
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion
PRD8139710 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 166.6 mg/m2 milligram(s)/sq. meter
- Max total dose
- 500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/001
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion
PRD4287912 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 166.6 mg/m2 milligram(s)/sq. meter
- Max total dose
- 500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/001
- MA holder
- FRESENIUS KABI ONCOLOGY PLC.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion
PRD4287910 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 166.6 mg/m2 milligram(s)/sq. meter
- Max total dose
- 500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/001
- MA holder
- FRESENIUS KABI ONCOLOGY PLC.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10818589 · Product
- Active substance
- (12M-1S2S-N-63S4SZ-11-ETHYL-12-2-S-1-METHOXYETHYL-5-4-METHYLPIPERAZIN-1-YLPYRIDIN-3-YL-1010-DIMETHYL-57-DIOXO-616263646566-HEXAHYDRO-11H-8-OXA-242-THIAZOLA-153-INDOLA-613-PYRIDAZINACYCLOUNDECAPHANE-4-YL-2-METHYLCYCLOPROPANE-1-CARBOXAMIDE
- Substance synonyms
- RMC-0706236, RMC-6236, (1S,2S)-N-[(7S,13S)-21-ethyl-20-[2-[(1S)-1-methoxyethyl]-5-(4-methylpiperazin-1-yl)pyridin-3-yl]-17,17-dimethyl-8,14-dioxo-15-oxa-4-thia-9,21,27,28-tetrazapentacyclo[17.5.2.12,5.19,13.022,26]octacosa-1(25),2,5(28),19,22(26),23-hexaen-7-yl]-2-methylcyclopropane-1-carboxamide, Daraxonrasib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10818590 · Product
- Active substance
- (12M-1S2S-N-63S4SZ-11-ETHYL-12-2-S-1-METHOXYETHYL-5-4-METHYLPIPERAZIN-1-YLPYRIDIN-3-YL-1010-DIMETHYL-57-DIOXO-616263646566-HEXAHYDRO-11H-8-OXA-242-THIAZOLA-153-INDOLA-613-PYRIDAZINACYCLOUNDECAPHANE-4-YL-2-METHYLCYCLOPROPANE-1-CARBOXAMIDE
- Substance synonyms
- RMC-0706236, RMC-6236, (1S,2S)-N-[(7S,13S)-21-ethyl-20-[2-[(1S)-1-methoxyethyl]-5-(4-methylpiperazin-1-yl)pyridin-3-yl]-17,17-dimethyl-8,14-dioxo-15-oxa-4-thia-9,21,27,28-tetrazapentacyclo[17.5.2.12,5.19,13.022,26]octacosa-1(25),2,5(28),19,22(26),23-hexaen-7-yl]-2-methylcyclopropane-1-carboxamide, Daraxonrasib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
Cisplatinum Accord, 1 mg/ml, koncentrat do sporządzania roztworu do infuzji.
PRD1951611 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 17743
- MA holder
- ACCORD HEALTHCARE POLSKA SP. Z O.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatinum Accord, 1 mg/ml, koncentrat do sporządzania roztworu do infuzji.
PRD1951612 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 17743
- MA holder
- ACCORD HEALTHCARE POLSKA SP. Z O.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatinum Accord, 1 mg/ml, koncentrat do sporządzania roztworu do infuzji.
PRD1951610 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 17743
- MA holder
- ACCORD HEALTHCARE POLSKA SP. Z O.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatinum Accord, 1 mg/ml, koncentrat do sporządzania roztworu do infuzji.
PRD415232 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 17743
- MA holder
- ACCORD HEALTHCARE POLSKA SP. Z O.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD669106 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 35.71 mg milligram(s)
- Max total dose
- 750 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 84223.00.00
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin-Ebewe, 10 Mg/Ml, Koncentrat Do Sporządzania Roztworu Do Infuzji
PRD766560 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 35.71 mg milligram(s)
- Max total dose
- 750 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 4500
- MA holder
- EBEWE PHARMA
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung
PRD1972920 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 35.71 mg milligram(s)
- Max total dose
- 750 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 46298.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Revolution Medicines Inc.
- Sponsor organisation
- Revolution Medicines Inc.
- Address
- 700 Saginaw Drive
- City
- Redwood City
- Postcode
- 94063-4752
- Country
- United States
Scientific contact point
- Organisation
- Revolution Medicines Inc.
- Contact name
- Melanie Caruno
Public contact point
- Organisation
- Revolution Medicines Inc.
- Contact name
- Melanie Caruno
Third parties 18
| Organisation | City, country | Duties |
|---|---|---|
| Atreo Inc. ORG-100045217
|
San Francisco, United States | Interactive response technologies (IRT) |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Other |
| Alturas Analytics Inc. ORG-100045347
|
Moscow, United States | Laboratory analysis |
| Discovery Life Sciences LLC ORG-100046461
|
Huntsville, United States | Laboratory analysis |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Myonex LLC ORG-100047430
|
Horsham, United States | Other |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| Sherpa Clinical Packaging LLC ORG-100042876
|
San Diego, United States | Other |
| Propharma Group LLC ORG-100048652
|
Raleigh, United States | Code 9 |
| Primevigilance Limited ORG-100027742
|
Guildford, United Kingdom | Code 8 |
| Edetek Inc. ORG-100045957
|
Princeton, United States | Other |
| Tempus Labs Inc. ORG-100044006
|
Chicago, United States | Laboratory analysis |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| PPD Development LP ORG-100011560
|
Wilmington, United States | Other |
| Aperio Clinical Outcomes LLC ORG-100046387
|
Durham, United States | Data management |
| Biotel Research LLC ORG-100039864
|
Rochester, United States | Other |
| PPD International Holdings LLC ORG-100007655
|
Zaventem, Belgium | Laboratory analysis |
Locations
5 EU/EEA countries · 41 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 66 | 10 |
| Germany | Ongoing, recruiting | 24 | 7 |
| Italy | Ongoing, recruiting | 24 | 7 |
| Netherlands | Ongoing, recruiting | 24 | 4 |
| Spain | Ongoing, recruiting | 24 | 13 |
| Rest of world
United States
|
— | 105 | — |
Investigational sites
Institut Curie
N/A, 26 Rue D Ulm, 75005, Paris
Centr Georges Francois Leclerc
N/A, 1 Rue Professeur Marion, 21000, Dijon
Oncopole Claudius Regaud
N/A, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Gustave Roussy
N/A, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospices Civils De Lyon
N/A, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
Centre Hospitalier Universitaire De Nantes
Oncologie Medicale, Unité d'Oncologie Thoracique, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Lille
N/A, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Hospital Foch
N/A, 40 Rue Worth, 92150, Suresnes
Centre Francois Baclesse
N/A, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut Bergonie
N/A, 229 Cours De L Argonne, 33000, Bordeaux
Thoraxklinik Heidelberg gGmbH
Universitätsklinikum Heidelberg, Roentgenstrasse 1, Rohrbach, Heidelberg
Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
Klinik für Lungen- & Bronchialheilkunde, Bethanienstrasse 21, Innenstadt, Moers
University Hospital Cologne AöR
Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Goethe University Frankfurt
Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Technische Universitaet Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Lungenfachklinik Immenhausen
N/A, Robert-Koch-Strasse 3, 34376, Immenhausen
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Onkologie, Hämatologie und Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità Operativa Complessa Fase 1, Largo Agostino Gemelli 8, 00168, Rome
Azienda Unita Sanitaria Locale Della Romagna
Unità Clinica Fase 1 – UO Oncologia di Ravenna, Viale Vincenzo Randi 5, 48121, Ravenna
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology and Hematology, Via Giacomo Venezian 1, 20133, Milan
I.F.O. Istituti Fisioterapici Ospitalieri
UOSD Clinical Trial Unit Phase 1and Precision Medicine, Via Elio Chianesi N 53, 00144, Rome
ASST Grande Ospedale Metropolitano Niguarda
Department: SC Oncologia Falck, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
SSD Oncologia polmonare-A.O.U. San Luigi Gonzaga - Orbassano, Regione Gonzole 10, 10043, Orbassano
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Clinical Research Unit, Plesmanlaan 121, 1066 CX, Amsterdam
Universitair Medisch Centrum Utrecht
Medical Oncology, Heidelberglaan 100, 3584 CX, Utrecht
Universitair Medisch Centrum Groningen
Department of pulmonology and tuberculosis, Hanzeplein 1, 9713 GZ, Groningen
Leids Universitair Medisch Centrum (LUMC)
Department of Pulmonary Diseases, Albinusdreef 2, 2333 ZA, Leiden
University Hospital Virgen Del Rocio S.L.
Oncologia, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Fundacion Jimenez Diaz
Oncologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Institut Catala D'oncologia
Oncologia, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Y Politecnico La Fe
Oncologia, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Complexo Hospitalario Universitario A Coruna
Oncologia Medica, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario 12 De Octubre
Oncologia, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Regional De Malaga
Oncologia Medica, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario Ramon Y Cajal
Oncologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Clinica Universidad De Navarra
Oncologia, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitari Vall D Hebron
Oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Fundacion Instituto Valenciano De Oncologia
Oncologia, Calle Professor Beltran Baguena 8, 46009, Valencia
Clinica Universidad De Navarra
Oncologia, Avenue Pio XII 36, 31008, Pamplona
Hospital Clinico San Carlos
Oncologia, Calle Del Profesor Martin Lagos Sn, 28040, 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 |
|---|---|---|---|---|---|
| France | 2024-07-17 | 2024-07-26 | |||
| Germany | 2024-09-04 | 2025-01-08 | |||
| Italy | 2024-08-07 | 2025-03-14 | |||
| Netherlands | 2024-08-16 | 2024-09-12 | |||
| Spain | 2024-07-24 | 2024-08-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 70 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol_2023-509571-16_AM4_Public | 5.0 |
| Protocol (for publication) | D1_RevMed_RMC-LUNG-101A_SubProtocol A_2023-509571-16_AM5_Public | 6.2 |
| Protocol (for publication) | D3_RevMed_RMC-LUNG-101A_Protocol Clarification Letter_Public | n/a |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101A_ Patient Diary 6291 and 6236_DEU_DE_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101A_ Patient Diary 6291 and 6236_FRA_FR_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101A_ Patient Diary 6291 and 6236_ITA_IT_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101A_ Patient Diary 6291 and 6236_NLD_BE_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101A_ Patient Diary 6291 and 6236_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101A_ Patient Diary 6291 and 6236_SPA_ES_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101A_ Patient Diary_DEU_DE_Public | 3.1 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101A_ Patient Diary_FRA_FR_Public | 3.1 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101A_ Patient Diary_ITA_IT_Public | 3.1 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101A_ Patient Diary_NLD_BE_Public | 3.1 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101A_ Patient Diary_Public | 3.1 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101A_ Patient Diary_SPA_ES_Public | 3.1 |
| Protocol (for publication) | RevMed_RMC-LUNG-101_Attachment-I protocol_ Dose Escalation OC simulation report_Public | n/a |
| Protocol (for publication) | RevMed_RMC-LUNG-101_Core Protocol_Signature Page_Public | 5.0 |
| Protocol (for publication) | RevMed_RMC-LUNG-101_Subprotocol A_Signature Page_Public | 6.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101_Recruitment-Arrangements_ES_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101A_Recruitment_arrangements_NL_English_Public | n/a |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101A_Recruitment-and-Informed-Consent-Procedure_DE_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101A_Recruitment-Arrangements_FR_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101A_Recruitment-Arrangements_IT_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_RMC-LUNG-101A_GP_letter_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_Pregnancy ICF_DE_German_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-A_Optional Biopsy_ICF_FR_French_Public | n/a |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Future Research ICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Main ICF Part 1_DE_German_clean_Public | 4.2 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Main ICF Part 2_DE_German_clean_Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Main ICF_DE_German_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Main_ICF_IT_ITA_Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Main-ICF_ES_Spanish_Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Main-ICF_FR_French_Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Optional_Biopsy_ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_PP-ICF_ES_Spanish_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Pregnancy-ICF_FR_French_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Pregnant-Partner-ICF_IT_Italian_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Privacy-Addendum-ICF_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Scout ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Scout ICF_ES_Spanish_Public | 0.2 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Scout_ICF__Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Scout_ICF_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_SIS-and-ICF-adults_NLD_NLD_Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_SIS-and-ICF-pregnant-partner_NLD_NLD_Public | 5.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101A_SmPCs_CARBO-cell_DEU-ENG_Public | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101A_SmPCs_Carboplatin Fresenius Kabi_EN_Public | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101A_SmPCs_Carboplatin-Ebewe_POL_EN_Public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101A_SmPCs_Cisplatin Hikma_DEU-ENG_Public | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101A_SmPCs_Cisplatin-Ebewe_POL_EN_Public | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101A_SmPCs_Cisplatino Hikma_SPA_EN_Public | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101A_SmPCs_Cisplatinum Accord_POL_EN_Public | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101A_SmPCs_Pembrolizumab_EN_Public | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101A_SmPCs_Pemetrexed STADA _DEU-ENG_Public | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101A_SmPCs_Pemetrexed Synthon_Netherlands-ENG_Public | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101A_SmPCs_Pemetrexed_EN_Public | n/a |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol Synopsis_2023-509571-16_AM4_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol Synopsis_2023-509571-16_IT_ITA_AM4_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core_Protocol_Synopsis_2023-509571-16_NL_DU_AM4_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core-protocol_synopsis_2023-509571-16_SPA_ES_AM4_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_CoreProtocol Synopsis_2023-509571-16_FR_FRA_AM4_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101A_SubProtocol A Synopsis_2023-509571-16_FR_FRA_Public | 6.2 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101A_SubProtocol A Synopsis_2023-509571-16_Public | 6.2 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101A_SubProtocol Lay Synopsis_2023-509571-16 _FR_FRA_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101A_Subprotocol Lay Synopsis_2023-509571-16 _IT_ITA_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101A_SubProtocol Lay Synopsis_2023-509571-16_NL_DU_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101A_SubProtocol Lay Synopsis_2023-509571-16_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101A_SubProtocol Lay synopsis_2023-509571-16_SPA_ES_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101A_SubProtocol synopsis_2023-509571-16_IT_ITA_Public | 6.2 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101A_SubProtocol_Synopsis_2023-509571-16_NL_DU_Public | 6.2 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101A_SubProtocol_synopsis_2023-509571-16_SPA_ES_Public | 6.2 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-29 | Spain | Acceptable 2024-06-17
|
2024-06-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-01 | Spain | Acceptable with conditions 2024-09-19
|
2024-09-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-25 | Spain | Acceptable 2025-02-14
|
2025-02-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-28 | Acceptable | 2025-03-24 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-28 | Acceptable | 2025-03-14 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-03 | Spain | 2025-04-03 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-15 | Acceptable | 2025-06-23 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-04-15 | Acceptable | 2025-06-05 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-04-15 | Acceptable | 2025-06-19 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-04-15 | Spain | Acceptable | 2025-05-13 |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-04-21 | Acceptable | 2025-06-03 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-09-30 | Spain | Acceptable 2025-12-11
|
2025-12-11 |