A Study of ARQ 531 in Patients With Selected Hematologic Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 120
Summary
- Conditions
- Chronic Lymphocytic Leukemia
- Diffuse Large B Cell Lymphoma
- Follicular Lymphoma
- Lymphoma, B Cell
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
- Richter's Transformation
- Small Lymphocytic Lymphoma
- Waldenstrom Macroglobulinemia
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Single group assignment (definition : A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.)Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, patients were enrolled using 3+3 dose escalation design. The starting dose of ARQ 531 in oral tablet form was 5mg/day continuously. The RP2D has been determined at 65mg/day, patients will be enrolled to ...
This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, patients were enrolled using 3+3 dose escalation design. The starting dose of ARQ 531 in oral tablet form was 5mg/day continuously. The RP2D has been determined at 65mg/day, patients will be enrolled to one of 8 cohorts depending on tumor histology and prior treatment history. Cycle length will be 28 days.
Tracking Information
- NCT #
- NCT03162536
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Director Merck Sharp & Dohme Corp.