drugset / Trial / NCT04512105
Pitavastatin in Combination With Venetoclax for Chronic Lymphocytic Leukemia or Acute Myeloid Leukemia
Phase 1
Completed
6 enrolled
University of California, Irvine
United States Department of Defense · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a phase I, dose-escalation, open-label clinical trial determining the safety and tolerability of adding Pitavastatin to Venetoclax in subjects with chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML). These are subjects who are newly diagnosed subjects with AML who are ineligible for intensive induction chemotherapy, relapsed/refractory CLL or newly diagnosed CLL.
Timeline
- Start
- 2020-12-02
- Primary completion
- 2024-07-20
- Completion
- 2025-02-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pitavastatin | Small molecule | 1 mg | Oral |
| Subject | Pitavastatin | Small molecule | 2 mg | Oral |
| Subject | Pitavastatin | Small molecule | 4 mg | Oral |
| Background | Venetoclax | Small molecule | 400 mg | Oral |