Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes
NCT ID: NCT02680795
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2016-04-27
2020-07-21
Brief Summary
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Detailed Description
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Enrollment into all cohorts will occur simultaneously rather than sequentially. Belinostat will be administered via a 30-minute infusion once daily from Day 1 to Day 5 of one 21-day cycle. Clinical safety will be monitored in each patient. Blood samples for PK analysis will be collected from Day 1 to Day 3, and urine samples for PK analysis will be collected from Day 1 to Day 4.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Wild Type UGT1A1
Cohort A: Open for Enrollment Wild Type UGT1A1, Belinostat IV
Belinostat IV
Cohort A:
Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Cohort B:
Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Cohort C:
Belinostat 750mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Heterozygous UGT1A1*28
Cohort B: Closed For Enrollment Heterozygous UGT1A1, Belinostat IV
Belinostat IV
Cohort A:
Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Cohort B:
Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Cohort C:
Belinostat 750mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Homozygous UGT1A1*28
Cohort C: Open For Enrollment Homozygous UGT1A1, Belinostat IV
Belinostat IV
Cohort A:
Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Cohort B:
Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Cohort C:
Belinostat 750mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Interventions
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Belinostat IV
Cohort A:
Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Cohort B:
Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Cohort C:
Belinostat 750mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient must have received at least 1 prior systemic therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening.
3. Patient has adequate hematological and hepatic functions.
Exclusion Criteria
2. Patient has HBV or HCV
3. Patient has a known HIV positive diagnosis.
4. Patient has congestive heart failure Class III/IV
5. Patient has had previous exposure to belinostat.
18 Years
ALL
No
Sponsors
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Axis Clinicals Limited
INDUSTRY
Axis Clinical Trials
OTHER
Acrotech Biopharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Wasim Khan, MD
Role: STUDY_DIRECTOR
Acrotech Biopharma Inc.
Locations
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John Wayne Cancer Institute @ Providence Saint John's Health Center
Santa Monica, California, United States
The Oncology Institute of Hope and Innovation
Whittier, California, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Countries
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Other Identifiers
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SPI-BEL-106
Identifier Type: -
Identifier Source: org_study_id
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