drugset / Trial / NCT04184869
Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, extension protocol designed to allow patients to continue to receive belinostat treatment after they have completed the protocol-specified assessments and procedures in a Spectrum sponsored belinostat study and have not met the criteria for treatment discontinuation in those studies. This extension of belinostat treatment allowance is not a part of the primary efficacy assessments for those trials. The extension is intended to provide all possible benefits to patients who are having a positive response to belinostat and must be under the Investigator's care. The additional treatment is optional and voluntary.
Timeline
- Start
- 2019-08-05
- Primary completion
- 2022-12-31
- Completion
- 2023-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atazanavir | Other / unclassified | 400 mg | — |
| Subject | Belinostat | Small molecule | 750 mg/m2 | Intravenous |
| Subject | Belinostat | Small molecule | 1000 mg/m2 | Intravenous |