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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acrotech Biopharma LLC
• Collaborator: Axis Clinicals Limited
• Treatments: Atazanavir Sulfate; Belinostat

Criteria

Inclusion Criteria:

• Patient has participated in, and completed, a Spectrum-sponsored clinical study with belinostat and did not meet the treatment discontinuation criteria in the study

• Investigator considers this extended belinostat treatment is appropriate for patient, and patient is suitable for the treatment

• Patient agrees to continue belinostat treatment as defined in the original clinical study protocol

• Patient must be willing to give written Informed Consent and must be able to adhere to dosing and visit schedules and meet study requirements

• Patient is willing to practice two forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of the study drug

Exclusion Criteria:

• Patient has an active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive belinostat benefit

• Patient is receiving any other treatment modalities including investigational products for their malignancy

• Patient has any medical or non-medical condition that may not be suitable for belinostat treatment, as determined by the investigator and according to the US package insert

• Patient is pregnant or is breastfeeding