To Evaluate the Safety and Pharmacokinetics of Belinostat in Patients Who Have Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes



Status:Recruiting
Conditions:Cancer, Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/16/2019
Start Date:March 2016
End Date:June 2019
Contact:CTM
Email:May.Hafez@sppirx.com
Phone:949-743-9265

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An Open-label, Nonrandomized, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Belinostat in Patients With Relapsed/Refractory Solid Tumors or Hematological Malignancies Who Have Wild-Type, Heterozygous, and Homozygous UGT1A1*28 Genotypes

This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat
in patients with relapsed/refractory solid tumors or hematological malignancies who have
heterozygous and homozygous UGT1A1*28 genotypes and wild-type UGT1A1 gene. Enrolled patients
will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype

This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat
in patients with relapsed/refractory solid tumors or hematological malignancies who have
heterozygous and homozygous UGT1A1*28 genotypes and wild-type UGT1A1 gene. Enrolled patients
will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype

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.

Inclusion Criteria:

1. Patient is diagnosed with advanced solid tumors or advanced hematological malignancy
that is relapsed/refractory, for which no standard salvage therapy exists.

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:

1. Patient is taking UGT1A1 inhibitors (eg, atazanavir, gemfibrozil, indinavir,
ketoconazole, sorafenib) at screening.

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.
We found this trial at
2
sites
Whittier, California 90606
Principal Investigator: Richy Agajanian, MD
Phone: 562-693-4477
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Canton, Ohio 44718
Principal Investigator: Nashat Gabrail, MD
Phone: 330-492-3345
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Canton, OH
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