drugset / Trial / NCT04184869

Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials

NCT04184869

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

EvaluationDrugModalityDoseRoute
Subject Atazanavir Other / unclassified 400 mg
Subject Belinostat Small molecule 750 mg/m2 Intravenous
Subject Belinostat Small molecule 1000 mg/m2 Intravenous