Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
460
Countries
4
Sites
16
Metastatic Pancreatic Ductal Adenocarcinoma
In the RAS G-12 population (referred to as RAS G12 population): To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on: PFS OS
Key facts
- Sponsor
- Revolution Medicines Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Apr 2025 → ongoing
- Decision date (initial)
- 2024-12-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Revolution Medicines Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Pharmacokinetic
In the RAS G-12 population (referred to as RAS G12 population):
To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on:
PFS
OS
Conditions and MedDRA coding
Metastatic Pancreatic Ductal Adenocarcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10033599 | Pancreatic adenocarcinoma metastatic | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- At least 18 years of age and has provided informed consent. Follow local regulatory requirements if the legal age of consent for study participation is >18 years old.
- ECOG performance status 0 or 1.
- Histologically or cytologically confirmed PDAC with metastatic disease
- Measurable disease per RECIST 1.1
- Adequate organ function (bone marrow, liver, kidney, coagulation)
- One prior line of systemic therapy in the metastatic setting.
- Documented RAS mutation status, either mutant or wild-type. RAS mutations are defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
- Able to take oral medications
Exclusion criteria 5
- Prior therapy with any direct RAS-targeted therapy (eg, degraders and/or inhibitors).
- History of or known central nervous system metastatic disease.
- Any conditions that may affect the ability to take or absorb study treatment.
- Major surgery within 4 weeks prior to randomization.
- Patient is unable or unwilling to comply with all protocol-required study visits or procedures.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 and as assessed by BICR. OS is defined as the time from randomization until death from any cause.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
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
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(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
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 12
SUB127678 · Substance
- Active substance
- Paclitaxel Albumin-Bound
- Pharmaceutical form
- POWDER FOR SUSPENSION FOR SOLUTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg/m2 milligram(s)/sq. meter
- Max total dose
- 0 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary repackaging and relabelling per cGMP.
SUB07721MIG · Substance
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg/m2 milligram(s)/sq. meter
- Max total dose
- 0 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary repackaging and relabelling per cGMP
SUB02772MIG · Substance
- Active substance
- Irinotecan Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg/m2 milligram(s)/square meter
- Max total dose
- 0 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary repackaging and relabelling per cGMP .
SUB02324MIG · Substance
- Active substance
- Gemcitabine Hydrochloride
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg/m2 milligram(s)/square meter
- Max total dose
- 0 mg/m2 milligram(s)/square meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02324MIG · Substance
- Active substance
- Gemcitabine Hydrochloride
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg/m2 milligram(s)/square meter
- Max total dose
- 0 mg/m2 milligram(s)/square meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02324MIG · Substance
- Active substance
- Gemcitabine Hydrochloride
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg/m2 milligram(s)/square meter
- Max total dose
- 0 mg/m2 milligram(s)/square meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02324MIG · Substance
- Active substance
- Gemcitabine Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg/m2 milligram(s)/square meter
- Max total dose
- 0 mg/m2 milligram(s)/square meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02324MIG · Substance
- Active substance
- Gemcitabine Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg/m2 milligram(s)/sq. meter
- Max total dose
- 0 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary repackaging and relabelling per cGMP.
SUB02324MIG · Substance
- Active substance
- Gemcitabine Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg/m2 milligram(s)/sq. meter
- Max total dose
- 0 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary repackaging and relabelling per cGMP.
SUB13910MIG · Substance
- Active substance
- Folinic Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg/m2 milligram(s)/sq. meter
- Max total dose
- 0 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary repackaging and relabelling per cGMP.
SUB09490MIG · Substance
- Active substance
- Oxaliplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg/m2 milligram(s)/sq. meter
- Max total dose
- 0 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary repackaging and relabelling per cGMP.
SUB08295MIG · Substance
- Active substance
- Irinotecan
- Pharmaceutical form
- CONCENTRATE FOR DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg/m2 milligram(s)/square meter
- Max total dose
- 0 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/11/933
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary repackaging and relabelling according to cGMP.
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
- Zeena Salman
Public contact point
- Organisation
- Revolution Medicines Inc.
- Contact name
- Zeena Salman
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Primevigilance USA Inc. ORG-100047266
|
Raleigh, United States | Code 8 |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Code 2, Code 5 |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Other |
| Cytel Inc. ORG-100042560
|
Cambridge, United States | Other |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
| Alturas Analytics Inc. ORG-100045347
|
Moscow, United States | Other |
| Foundation Medicine Inc. ORG-100040457
|
Cambridge, United States | Other |
| Aperio Clinical Outcomes LLC ORG-100046387
|
Durham, United States | E-data capture |
Locations
4 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 32 | 4 |
| Germany | Ongoing, recruitment ended | 32 | 4 |
| Italy | Ongoing, recruitment ended | 40 | 4 |
| Spain | Ongoing, recruitment ended | 32 | 4 |
| Rest of world
Japan, United States
|
— | 324 | — |
Investigational sites
Institut Paoli Calmettes
service d'oncologie medicale, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre De Lutte Contre Le Cancer Eugene Marquis
Service d'Oncologie médicale, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Institut Gustave Roussy
Pathologies Digestives, 114 Rue Edouard Vaillant, 94800, Villejuif
Hopital Paul Brousse
Service oncologie digestive et medicale, 12 Avenue Paul Vaillant Couturier, 94804, Villejuif Cedex
Universitaetsklinikum Ulm AöR
Internal Medicine, Center for Internal Medicne Ulm Universitys, Albert-Einstein-Allee 23, Eselsberg, Ulm
Klinikum der Universitaet Muenchen AöR
Hematology/ Oncology, Medizinische Klinik III, University Hospital LMU Munich, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Heidelberg AöR
National Center of Tumor Diseases (NCT), Department of Medical Oncology, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Charite Universitaetsmedizin Berlin KöR
Hematology, Oncology, Tumorimmunology, Chariteplatz 1, Mitte, Berlin
Istituto Oncologico Veneto
Oncologia, Via Gattamelata 64, 35128, Padova
Istituto Europeo Di Oncologia S.r.l.
Oncologia Medica Gastrointestinale e Tumori Neuroendocrini, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Ospedaliero Universitaria Pisana
UO Oncologia Medica 2, Via Roma 67, 56126, Pisa
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica, Via Giacomo Venezian 1, 20133, Milan
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
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 | 2025-03-19 | 2025-03-24 | 2025-07-18 | ||
| Germany | 2025-06-27 | 2025-07-09 | 2025-11-07 | ||
| Italy | 2025-02-18 | 2025-02-24 | 2025-07-18 | ||
| Spain | 2025-03-28 | 2025-04-02 | 2025-07-18 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 3 · Art. 38 CTR
Temporary halt TH-79217
- Halt date
- 2025-04-03
- Planned restart
- 2025-04-16
- Member states concerned
- France
- Publication date
- 2025-04-15
- Reason
- Study management related
- Explanation
- A temperature excursion at a drug supply depot affected the gemcitabine supply for clinical trial RMC-6236-302. The gemcitabine supply was assessed by the manufacturer as not fit for use. Until a replacement batch is labelled and Qualified Person (QP) certified, centrally sourced gemcitabine is unavailable to ship to clinical trial sites to supply this study. After discussion with investigators and taking into consideration patients’ interests, the Sponsor allowed sites to utilize local supplies of gemcitabine during the period for which centrally supplied gemcitabine is not available. On 03Apr2025, the sponsor also informed sites that screening of new patients should be paused until central supply of gemcitabine is re-established. This temporary halt of recruitment is not related to any safety concerns.
- Follow-up measures
- Screening of new patients was paused until central supply of gemcitabine is re-established.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-79215
- Halt date
- 2025-04-03
- Planned restart
- 2025-04-16
- Member states concerned
- Italy
- Publication date
- 2025-04-15
- Reason
- Study management related
- Explanation
- A temperature excursion at a drug supply depot affected the gemcitabine supply for clinical trial RMC-6236-302. The gemcitabine supply was assessed by the manufacturer as not fit for use. Until a replacement batch is labelled and Qualified Person (QP) certified, centrally sourced gemcitabine is unavailable to ship to clinical trial sites to supply this study. After discussion with investigators and taking into consideration patients’ interests, the Sponsor allowed sites to utilize local supplies of gemcitabine during the period for which centrally supplied gemcitabine is not available. On 03Apr2025, the sponsor also informed sites that screening of new patients should be paused until central supply of gemcitabine is re-established. This temporary halt of recruitment is not related to any safety concerns.
- Follow-up measures
- Screening of new patients was paused until central supply of gemcitabine is re-established.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-79213
- Halt date
- 2025-04-03
- Planned restart
- 2025-04-16
- Member states concerned
- Spain
- Publication date
- 2025-04-15
- Reason
- Study management related
- Explanation
- A temperature excursion at a drug supply depot affected the gemcitabine supply for clinical trial RMC-6236-302. The gemcitabine supply was assessed by the manufacturer as not fit for use. Until a replacement batch is labelled and Qualified Person (QP) certified, centrally sourced gemcitabine is unavailable to ship to clinical trial sites to supply this study. After discussion with investigators and taking into consideration patients’ interests, the Sponsor allowed sites to utilize local supplies of gemcitabine during the period for which centrally supplied gemcitabine is not available. On 03Apr2025, the sponsor also informed sites that screening of new patients should be paused until central supply of gemcitabine is re-established. This temporary halt of recruitment is not related to any safety concerns.
- Follow-up measures
- Screening of new patients was paused until central supply of gemcitabine is re-established.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 52 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-516063-89_red_san | 3.0 |
| Protocol (for publication) | D4_Patient facing document_Patient Facing Documentation_copyright statement_san | 1.0 |
| Recruitment arrangements (for publication) | K1_2024-516063-89_Recruitment and consent_san | v2 |
| Recruitment arrangements (for publication) | K1_EN_Recruitment arrangement_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_RMC-6236-302_Recruitment and Informed consent procedure_San | 1 |
| Subject information and informed consent form (for publication) | L1_2024-516063-89_ICF_Main_red | V6.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-516063-89_ICF_Pre-screening_red | V2.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-516063-89_ICF_Pregnant partner_red | V3.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_BfS Information for Germany_DE_2024-516063-89-00_san | NA |
| Subject information and informed consent form (for publication) | L1_ICF_FSR_san_red | V1.0DEU1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_main_san_red | V6DEUde1 |
| Subject information and informed consent form (for publication) | L1_ICF_PP_PFU_san_red | 3.0DEU1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pre-screening_san_red | 2.0DEU1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Pregnant Partner_Red | V3.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FSR_CL_San | V1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FSR_Red-San | 1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_CL_redacted | 6.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Privacy ICF_CL_san | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Privacy_CL_Red-San | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CL_Red-San | V6.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CL_red-san | V4.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ES_Red | V3.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening_CL_Red-San | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening_CL_red-san | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-Screening_Red | V2.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_CL_San | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_CL_san | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L2_2024-516063-89_Patient diary_red | V01FRAfr01 |
| Subject information and informed consent form (for publication) | L2_2024-516063-89_Patient ID card_san | V01FRAfr |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Diary_Red | V1.0ESPes1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient ID Card | V1.0ESP |
| Subject information and informed consent form (for publication) | L2_OtherSubInfo_PatientCard_san | V01DEU(de) |
| Subject information and informed consent form (for publication) | L2_OtherSubInfo_PatientDiary_san_red | 01DEU01 |
| Subject information and informed consent form (for publication) | L2_RASolute 302_Participant Diary_V01 ITA_Red-San | V01ITA01 |
| Subject information and informed consent form (for publication) | L2_RASolute 302_Patient ID Card_V01 ITA_San | V01ITA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_5-fluorouracil | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_folinic acid | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_gemcitabine hydrochloride_100mg_ml | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_gemcitabine hydrochloride_1g | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_gemcitabine hydrochloride_200mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_gemcitabine hydrochloride_2g | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_gemcitabine hydrochloride_38 | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_gemcitabine hydrochloride_40 | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_irinotecan hydrochloride | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_irinotecan pegylated liposomal formulation | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_oxaliplatin | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_paclitaxel formulated as albumin bound nanoparticles | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ENG_2024-516063-89_red_san | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES_2024-516063-89_red_san | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR_2024-516063-89_red_san | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT_2024-516063-89_red_san | 3.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-13 | Spain | Acceptable 2024-12-13
|
2024-12-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-20 | Acceptable | 2025-01-24 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-24 | Spain | Acceptable 2024-12-13
|
2025-01-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-24 | Acceptable | 2025-04-04 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-16 | Spain | Acceptable 2025-09-17
|
2025-09-18 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-30 | Spain | Acceptable 2025-12-01
|
2025-12-03 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-21 | Spain | Acceptable with conditions 2026-04-07
|
2026-04-08 |