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

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

August 5, 2019

Primary Completion Date

December 31, 2022

Study Completion Date

March 31, 2023

Conditions
Solid TumorHematological Malignancies
Interventions
DRUG

Belinostat

"Patients can continue to receive belinostat treatment as described in the original study protocol or can be treated per the Investigator's standard of care.~Belinostat Dose Cohort A \& B: 1000mg/m2 Belinostat Dose Cohort C: 750mg/m2 Frequency: once cycle of 21 days: cycle 1, Day 1 and Cycle1, Day 2 to Day 5~Dose modifications to belinostat during treatment on this extension protocol will be in accordance with the belinostat package insert.~All patients who receive at least one dose of belinostat treatment in this extension study will be followed for safety through 35 (+/-5) days after their last dose of the treatment or until all treatment related AEs have resolved or returned to Baseline/Grade I, whichever is longer, or until it is determined by the treating physician that the outcome will not change with further follow-up."

DRUG

Atazanavir

"Patients can continue to receive belinostat treatment as described in the original study protocol or can be treated per the Investigator's standard of care.~Dose: 750mg/ m2 (Belinostat IV), 400mg (Atazanavir) Frequency: two cycles of 21 days (Belinostat administered through Cycle 2, Day 5) Atazanavir 400mg administered Cycle 1 Day 15 to Day 21, and Cycle 2 Day 1 to Day 5~Dose modifications to belinostat during treatment on this extension protocol will be in accordance with the belinostat package insert.~All patients who receive at least one dose of belinostat treatment in this extension study will be followed for safety through 35 (+/-5) days after their last dose of the treatment or until all treatment related AEs have resolved or returned to Baseline/Grade I, whichever is longer, or until it is determined by the treating physician that the outcome will not change with further follow-up."

Trial Locations (1)

90404

John Wayne Cancer Institute @ Providence Saint John's Health Center, Santa Monica

Sponsors
All Listed Sponsors
collaborator

Axis Clinicals Limited

INDUSTRY

lead

Acrotech Biopharma Inc.

INDUSTRY

NCT04184869 - Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials | Biotech Hunter | Biotech Hunter