A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 190
Summary
- Conditions
- B Cell Lymphoma
- Chronic Lymphocytic Leukemia
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
- Small Lymphocytic Lymphoma
- Waldenstrom Macroglobulinemia
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study includes 3 parts: phase 1 (LOXO-305 monotherapy dose escalation and dose expansion), phase 1b (LOXO-305 combination therapy dose expansion), and phase 2 (LOXO-305 monotherapy dose expansion). In phase 1, patients will be enrolled using an accelerated titration design. The starting dose of...
This study includes 3 parts: phase 1 (LOXO-305 monotherapy dose escalation and dose expansion), phase 1b (LOXO-305 combination therapy dose expansion), and phase 2 (LOXO-305 monotherapy dose expansion). In phase 1, patients will be enrolled using an accelerated titration design. The starting dose of LOXO-305 in oral tablet form is 25 mg/day (e.g., 25 mg once daily [QD]). Once the MTD and/or RP2D is identified in phase 1 dose escalation, enrollment will continue to phase 1 dose expansion and can commence to phase 1b (Arms A and B). For phase 2, patients will be enrolled to one of seven phase 2 dose expansion cohorts depending on tumor histology and prior treatment history. Cycle length will be 28 days.
Tracking Information
- NCT #
- NCT03740529
- Collaborators
- Not Provided
- Investigators
- Study Director: Donald Tsai, MD, PhD Loxo Oncology
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