2024-514030-20-00
Not yet recruiting
Phase 2
ENGIC - 01 COLOSOTO: A single-arm phase II study evaluating 5-fluorouracil plus Panitumumab (anti-EGFR) and Sotorasib (KRAS G12C inhibitor) in first-line treatment of patients non-eligible for a doublet/triplet chemotherapy with advanced unresectable KRAS G12C mutated colorectal adenocarcinoma
Fondation Franc.Cancerologie Digestive80 sites in 2 countries37 target enrollmentStarted: March 24, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Fondation Franc.Cancerologie Digestive
- Enrollment
- 37
- Locations
- 80
- Primary Endpoint
- The rate of patients alive without progression 8 months after the inclusion.
Overview
Brief Summary
Progression-free survival of under 5-fluorouracil plus Panitumumab and Sotorasib (KRAS G12C inhibitor) at 8 months in first-line treatment of patients non-eligible for a doublet/triplet chemotherapy with advanced unresectable KRAS G12C mutated colorectal adenocarcinoma.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Provides written informed consent for the study.
- •Life expectancy >6 months
- •Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 3 months after discontinuation of the experimental treatments
- •Patient affiliated to a social security scheme for France, or equivalent for other countries
- •Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma
- •Agreement to participate to biological studies (blood samples for ctDNA and send tumour block).
- •Patient unfit for doublet/triplet regimen: Frail patients (WHO PS=2),patient between 70 and 75 years old with WHO PS 1 - 2, patient ≥ 75 years old with WHO PS 0-2
- •Proven KRAS G12C mutation as locally assessed by means of a IVDR compliant test.
- •Measurable lesion according to the Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1).
Exclusion Criteria
- •Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume <50%) severe insufficiency
- •Patient with interstitial lung disease or pulmonary fibrosis
- •Has a known psychiatric or substance abuse disorder that would interfere with the patient’s ability to cooperate with the requirements of the study
- •Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent
- •Pregnant or breastfeeding woman
- •Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons
- •Clinically significant cardiac abnormalities including prior history of any of the following: severe cardiomyopathy, congestive heart failure of New York Heart Association grade ≥3, history of clinically significant (i.e., active) atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments)
- •Patients with Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiencies (uracilemia ≥ 16 ng/mL)
- •Immunotherapy within 3 months before the beginning of the treatment study
- •Patient under treatment by strong CYP3A4 inducers
Outcomes
Primary Outcomes
The rate of patients alive without progression 8 months after the inclusion.
The rate of patients alive without progression 8 months after the inclusion.
Secondary Outcomes
- PFS will be defined as the time between date of inclusion and the date of the first radiological progression using RECIST v1.1 criteria and according to the investigator assessment or death
- DCR will be defined at each time-point as complete (CR), partial (PR), stability (S), progression (P) or not evaluable with imageries and according to the investigator
- ORR will be evaluated throughout the treatment by the imageries and according to RECIST v1.1 criteria.
- BOR will be evaluated throughout the treatment by the imageries and according to RECIST v1.1 criteria
- DoR is defined as the time between the first response of the patient and the date of radiological progression or death
- TTP will be defined as the time between the date of inclusion and the date of the first radiological progression. The death linked to the cancer’s evolution will also be considered as an event
- OS is defined by the time between the date of inclusion and the date of death (regardless of the cause)
- Quality of life will be assessed with the EORTC QLQC30 questionnaire at each evaluation. The questionnaires are completed before the first treatment and during the study
- Geriatric assessments will be performed at baseline and during treatment using the G-CODE and G8-SCORE
- Toxicity, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be recorded until 30 days after the last administration of treatment
Investigators
coordinator
Scientific
Fondation Franc.Cancerologie Digestive
Study Sites (80)
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