8
Participants
Start Date
August 5, 2019
Primary Completion Date
December 31, 2022
Study Completion Date
March 31, 2023
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."
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."
John Wayne Cancer Institute @ Providence Saint John's Health Center, Santa Monica
Lead Sponsor
Collaborators (1)
Axis Clinicals Limited
INDUSTRY
Acrotech Biopharma Inc.
INDUSTRY