drugset / Trial / NCT02117336
Clinical Study of Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
Phase 1
Suspended
36 enrolled
Piramal Enterprises Limited
Dana-Farber Cancer Institute · collabNorris Cotton Cancer Center · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open-label, Phase I/Ib trial with a dose escalation phase, followed by a dose extension phase. The objective of the dose escalation phase is to evaluate the pharmacokinetics (PK) and MTD of P1446A-05 in relapsed/refractory CLL and the objective of the dose extension phase is to evaluate the safety, efficacy and pharmacodynamics of P1446A-05 in 14 patients at the MTD level.
Timeline
- Start
- 2014-06
- Primary completion
- 2016-10
- Completion
- 2017-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | P1446A-05 | Unknown | 25 mg | — |
| Subject | P1446A-05 | Unknown | 50 mg | — |
| Subject | P1446A-05 | Unknown | 75 mg | — |
| Subject | P1446A-05 | Unknown | 125 mg | — |
| Subject | P1446A-05 | Unknown | 200 mg | — |
| Subject | P1446A-05 | Unknown | 275 mg | — |