Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Locally Advanced Pancreatic Carcinoma
- Metastatic Pancreatic Carcinoma
- Recurrent Pancreatic Carcinoma
- Stage III Pancreatic Cancer AJCC v8
- Stage IV Pancreatic Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To determine the efficacy of the combination of binimetinib and encorafenib as >= 2nd line of treatment for patients with metastatic pancreatic cancer with BRAF V600E mutation. SECONDARY OBJECTIVES: I. To determine in patients treated with the combination of binimetinib and enc...
PRIMARY OBJECTIVE: I. To determine the efficacy of the combination of binimetinib and encorafenib as >= 2nd line of treatment for patients with metastatic pancreatic cancer with BRAF V600E mutation. SECONDARY OBJECTIVES: I. To determine in patients treated with the combination of binimetinib and encorafenib as >= 2nd line of treatment for patients with metastatic pancreatic cancer with BRAF V600E mutation: Ia. The median progression-free survival. Ib. The median overall survival. Ic. Duration of response. Id. Time to response. Ie. The safety and tolerability. OUTLINE: Patients receive encorafenib orally (PO) once daily (QD) and binimetinib PO twice daily (BID) on days 1-25. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 5 years.
Tracking Information
- NCT #
- NCT04390243
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Andrew E Hendifar Academic and Community Cancer Research United
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