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

Acrotech Biopharma

Status and phase: Completed; Phase 1

Conditions: Solid Tumor; Hematological Malignancies

Treatments: Drug: Atazanavir; Drug: Belinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT04184869

SPI-BEL-502

Details and patient eligibility

About

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.

Full description

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.

This protocol will be available for all patients who have completed the protocol-specified assessments and procedures in Spectrum sponsored belinostat studies. Patients can receive belinostat treatment according to the treatment schedule that is being administered at the time they complete participation in the original clinical study protocol or can be treated per the Investigator's standard of care. Doe modifications during treatment on this extension protocol will be in accordance with the U.S. package insert.

Safety will continue to be followed during the extended belinostat treatment. Therapeutic benefits or efficacy will be followed to the extent that is evaluated according to the institution's standard of care.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 4 patient groups

Wild Type UGT1A1

Other group

Description:

Cohort A: Wild Type, UGT1A1, Belinostat IV Dose: 1000 mg/m2 Frequency: 30-minute infusion once daily from Day 1 to Day 5 of a 21-day cycle. Duration: Up to five 21-day cycles (15 weeks) Treatment Period: Up to a total of six 21-day cycles (18 weeks) of treatment total from both the original study protocol and this extension protocol.

Treatment:

Drug: Belinostat

Heterozygous UGT1A1*28

Other group

Description:

Cohort B: Heterozygous, UGT1A1, Belinostat IV Dose: 1000 mg/m2 Frequency: 30-minute infusion once daily from Day 1 to Day 5 of a 21-day cycle. Duration: Up to five 21-day cycles (15 weeks) Treatment Period: Up to a total of six 21-day cycles (18 weeks) of treatment total from both the original study protocol and this extension protocol.

Treatment:

Drug: Belinostat

Homozygous UGT1A1*28

Other group

Description:

Cohort C: Homozygous, UGT1A1, Belinostat IV Dose: 750 mg/m2 Frequency: 30-minute infusion once daily from Day 1 to Day 5 of a 21-day cycle. Duration: Up to five 21-day cycles (15 weeks) Treatment Period: Up to a total of six 21-day cycles (18 weeks) of treatment total from both the original study protocol and this extension protocol.

Treatment:

Drug: Belinostat

Belinostat & Atazanavir

Other group

Description:

Arm: Homozygous UGT1A1\*28 genotype subjects with Belinostat IV \& Atazanavir 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 Duration: Up to five 21-day cycles (15 weeks) Treatment Period: Up to a total of six 21-day cycles (18 weeks) of treatment total from both the original study protocol and this extension protocol.

Treatment:

Drug: Atazanavir

Drug: Belinostat