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

Primary Purpose

Solid Tumor, Hematological Malignancies

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Belinostat

Atazanavir

About this trial

This is an interventional treatment trial for Solid Tumor focused on measuring Belinostat, beleodaq, Belinostat treatment extension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

John Wayne Cancer Institute @ Providence Saint John's Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

Wild Type UGT1A1

Heterozygous UGT1A1*28

Homozygous UGT1A1*28

Belinostat & Atazanavir

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Evaluation of safety include assessment of all SAEs, and all deaths on study or within 35 (±5) days of last study treatment

Frequency of adverse events (AEs & serious adverse events (SAEs)

Secondary Outcome Measures

Full Information

NCT ID

NCT04184869

First Posted

February 7, 2019

Last Updated

May 1, 2023

Sponsor

Acrotech Biopharma Inc.

Collaborators

Axis Clinicals Limited

1. Study Identification

Unique Protocol Identification Number

NCT04184869

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

August 5, 2019 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acrotech Biopharma Inc.

Collaborators

Axis Clinicals Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Solid Tumor, Hematological Malignancies

Keywords

Belinostat, beleodaq, Belinostat treatment extension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Wild Type UGT1A1

Arm Type

Other

Arm Description

Arm Title

Heterozygous UGT1A1*28

Arm Type

Other

Arm Description

Arm Title

Homozygous UGT1A1*28

Arm Type

Other

Arm Description

Arm Title

Belinostat & Atazanavir

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Belinostat

Other Intervention Name(s)

beleodaq

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Atazanavir

Other Intervention Name(s)

Reyataz

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evaluation of safety include assessment of all SAEs, and all deaths on study or within 35 (±5) days of last study treatment

Description

Frequency of adverse events (AEs & serious adverse events (SAEs)

Time Frame

35 (±5) days after the last dose of belinostat

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erard Gilles, MD

Organizational Affiliation

Navitas Life Sciences Inc.

Official's Role

Study Director

Facility Information:

Facility Name

John Wayne Cancer Institute @ Providence Saint John's Health Center

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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