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

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ClinicalTrials.gov Identifier: NCT04184869
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : June 10, 2021
Sponsor:
Collaborator:
Axis Clinicals Limited
Information provided by (Responsible Party):
Acrotech Biopharma LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumor Hematological Malignancies Drug: Belinostat Drug: Atazanavir Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Extension Study to Allow Continued Treatment of Patients Who Have Participated in Spectrum-Sponsored Clinical Studies With Belinostat
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Wild Type UGT1A1

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.

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.

Other Name: beleodaq

Heterozygous UGT1A1*28

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.

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.

Other Name: beleodaq

Homozygous UGT1A1*28

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.

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.

Other Name: beleodaq

Belinostat & Atazanavir

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.

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.

Other Name: beleodaq

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.

Other Name: Reyataz




Primary Outcome Measures :
  1. Evaluation of safety include assessment of all SAEs, and all deaths on study or within 35 (±5) days of last study treatment [ Time Frame: 35 (±5) days after the last dose of belinostat ]
    Frequency of adverse events (AEs & serious adverse events (SAEs)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184869


Contacts
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Contact: Melissa Brugard, MSW 218.284.9863 m.burgard@axisclinicals.com

Locations
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United States, California
John Wayne Cancer Institute @ Providence Saint John's Health Center Recruiting
Santa Monica, California, United States, 90404
Contact: Tracy DeBelles    310-582-7375    tracy.debelles@providence.org   
Contact: Mini Gill    310-582-7437    Jaya.Gill@providence.org   
Sponsors and Collaborators
Acrotech Biopharma LLC
Axis Clinicals Limited
Investigators
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Study Director: Erard Gilles, MD Navitas Life Sciences Inc.
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Responsible Party: Acrotech Biopharma LLC
ClinicalTrials.gov Identifier: NCT04184869    
Other Study ID Numbers: SPI-BEL-502
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acrotech Biopharma LLC:
Belinostat
beleodaq
Belinostat treatment extension
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases
Atazanavir Sulfate
Belinostat
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents
Histone Deacetylase Inhibitors