drugset / Trial / NCT03687125
Tinostamustine Conditioning and Autologous Stem Cell
Non-randomizedSequentialOpen-labelTreatment
Summary
Phase 1 The primary objectives of Phase 1 of this study are to: * Establish the safety, toxicity, and maximum tolerated dose (MTD) of the tinostamustine conditioning regimen. * Identify the recommended Phase 2 dose (RP2D) of tinostamustine for use in the Phase 2 portion of the study. The secondary objective of Phase 1 of this study is to: \- Investigate the pharmacokinetics (PK) of tinostamustine.
Timeline
- Start
- 2018-10-15
- Primary completion
- 2019-04-17
- Completion
- 2019-04-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tinostamustine | Other / unclassified | 180 mg/m2 | Intravenous |
| Subject | Tinostamustine | Other / unclassified | 220 mg/m2 | Intravenous |