Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Solid Tumor, Adult
- Type
- Interventional
- Phase
- Phase 1Phase 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
This study is a single-arm, open-label, phase 1/2 trial to determine the recommended phase 2 dose of neratinib and sodium valproate when given in combination to patients with advanced solid tumors in 28 day cycles. The phase II portion of the study will evaluate the combination at the RP2D in 3 coho...
This study is a single-arm, open-label, phase 1/2 trial to determine the recommended phase 2 dose of neratinib and sodium valproate when given in combination to patients with advanced solid tumors in 28 day cycles. The phase II portion of the study will evaluate the combination at the RP2D in 3 cohorts of RAS mutated tumors, KRAS mutant colorectal cancer, KRAS mutant pancreatic cancer, and K or N RAS mutant solid tumors.
Tracking Information
- NCT #
- NCT03919292
- Collaborators
- Puma Biotechnology, Inc.
- Investigators
- Principal Investigator: Andrew Poklepovic, MD Massey Cancer Center
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