drugset / Trial / NCT03547700
Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL)
Phase 1/2
Terminated
11 enrolled
University of Michigan Rogel Cancer Center
Big Ten Cancer Research Consortium · collabTakeda · collab
NaSequentialOpen-labelTreatment
Summary
Single arm phase I/II study of ixazomib and romidepsin in relapsed/refractory PTCL. Each cycle is 28 days. Patients will continue to receive therapy until progressive disease, unacceptable toxicity, or if any other withdrawal criteria are met. The phase I study includes three dose levels. The phase II study will include treatment with ixazomib and romidepsin at the MTD established in the Phase I study.
Timeline
- Start
- 2018-09-26
- Primary completion
- 2020-08-27
- Completion
- 2020-08-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ixazomib | Unknown | 4 mg | Oral |
| Subject | Romidepsin | Peptide | 10 mg/m2 | — |
| Subject | Romidepsin | Peptide | 14 mg/m2 | — |