Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Solid Tumor
- BRAF Gene Alteration
- BRAF Gene Mutation
- MAP2K1 Gene Alteration
- MAP2K1 Gene Mutation
- MAP2K2 Gene Alteration
- MAP2K2 Gene Mutation
- MEK Alteration
- MEK Mutation
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This multi-center, phase II study will be conducted in two parts and assess the clinical benefit, safety, pharmacokinetics, and pharmacodynamics of ulixertinib (BVD-523) in patients with advanced malignancies. Part A (tumor histology agnostic) will be open label and enroll patients to one of six gro...
This multi-center, phase II study will be conducted in two parts and assess the clinical benefit, safety, pharmacokinetics, and pharmacodynamics of ulixertinib (BVD-523) in patients with advanced malignancies. Part A (tumor histology agnostic) will be open label and enroll patients to one of six groups based on their tumor alteration. Group 1: Patients with tumors, other than colorectal cancer (CRC), having a BRAF alteration that results in an amino acid change at positions G469, L485, or L597. Group 2: Patients with tumors, other than CRC, having a defined Class 2 BRAF alteration (see Appendix 2 of protocol). Group 3: Patients with tumors, other than CRC, having an atypical BRAF alteration (non V600) that is not specified in Group 1 or Group 2. Group 4: Patients with CRC having any atypical BRAF alteration. Group 5: Patients with tumors, other than CRC, harboring alterations in MEK1/2. Group 6: Patients with CRC harboring alterations in MEK1/2. Part B (tumor histology specific) will randomly enroll patients with one of up to three specified tumor histologies to receive either ulixertinib or the physician's choice of treatment in a 2:1 ratio. Tumors must harbor a specified MEK or atypical BRAF alteration. If a patient progresses on physician's choice of treatment, crossover to the ulixertinib arm is permitted.The specific histologies to be included in this part will be selected based on available data and discussion with the clinical investigators, the medical monitor, and the sponsor.
Tracking Information
- NCT #
- NCT04488003
- Collaborators
- Not Provided
- Investigators
- Not Provided
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