Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Experimental: Safety Lead-in Cohort 1: Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks Irinotecan 180 mg/m2 (90-minute IV infusion) eve
Sponsors
Pfizer Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1.Phase 3: Male/female with more than equal to 16 years old (where permitted locally) 2.Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation 3.Prior systemic treatment in metastatic setting 4.SLI: 0-1 regimens 5. Phase 3: None 6.Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis more than 6 month from end of adj/neoadjuvant treatment 7.Measurable disease (Phase 3) 8. ECOG PS 0-1 9. Adequate organ function
Exclusion criteria
Exclusion criteria: 1. Tumors that are locally confirmed or unknown MSI-H or dMMR unless participant is ineligible to receive immune checkpoint inhibitors due to a pre-existing medical condition 2. Active bacterial or viral infections in 2 weeks prior to starting dosing 3.Symptomatic brain metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 3: Progression free survival, by blinded independent reviewTimepoint: Time Frame: Duration of Phase 3, approximately 34 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 3: Change from Baseline in the Patient Global Impression of Severity (PGIS)Timepoint: Time Frame: Duration of Phase 3, approximately 34 months;Phase 3: Confirm the MSI-status in tumor tissueTimepoint: Time Frame: Once, pre-treatment ];Phase 3: Determine the correlation between cfDNA genetic alterations and clinical outcomeTimepoint: Time Frame: Predose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 15 and Cycle 7 Day 1. Each cycle is 28 days for all treatments except for oxaliplatin/capecitabine treatment which is 21 days;hase 3: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiogramsTimepoint: Time Frame: Duration of Phase 3, approximately 34 months;Phase 3: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)Timepoint: Time Frame: Duration of Phase 3, approximately 34 months;Phase 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) QuestionnaireTimepoint: Time Frame: Duration of Phase 3, approximately 34 months;Phase 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnairesTimepoint: Time Frame: Duration of Phase 3, approximately 34 months;Phase 3: Duration of response by blinded independent review and by InvestigatorTimepoint: Time Frame: Duration of Phase 3, approximately 34 months;Phase 3: Incidence of adverse eventsTimepoint: Time Frame: Duration of Phase 3, approximately 34 months;Phase 3: Overall response rate by blinded independent review and by InvestigatorTimepoint: Time Frame: Duration of Phase 3, approximately 34 months;Phase 3: Overall survivalTimepoint: Time Frame: Duration of Phase 3, approximately 34 months;Phase 3: Progression free survival 2 by InvestigatorTimepoint: Time Frame: Duration of Phase 3, approximately 34 months;Phase 3: Progression free survival by InvestigatorTimepoint: Time Frame: Duration of Phase 3, approximately 34 months;Phase 3: Time to response by blin | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, India, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Seema Pai
Pfizer Limited
Outcome results
None listed