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| Name | Class |
|---|---|
| Axis Clinicals Limited | INDUSTRY |
| Axis Clinical Trials | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wild Type UGT1A1 | Experimental | Cohort A: Open for Enrollment Wild Type UGT1A1, Belinostat IV |
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| Heterozygous UGT1A1*28 | Experimental | Cohort B: Closed For Enrollment Heterozygous UGT1A1, Belinostat IV |
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| Homozygous UGT1A1*28 | Experimental | Cohort C: Open For Enrollment Homozygous UGT1A1, Belinostat IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belinostat IV | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and urine concentrations of belinostat will be measured | PK will be measured for area under the time-concentration curve (AUC), steady state volume of distribution (Vdss),PK will be measured for total body clearance (CLtot),PK will be measured for fraction excreted unchanged (fe), PK will be measured for renal clearance (CLren), PK will be measured for non-renal clearance (CLnonren), PK will be measured for peak concentration (Cmax),and half-life (t1/2) | 26 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess overall incidence of treatment emergent adverse events (TEAEs) using CTCAE version 4.03 | Assess Safety of belinostat in patients with wild type, heterozygous, and homozygousUGT1A1*28 genotypes | 26 Weeks |
| Assess any adverse events (AEs) (changes in physical exam or laboratory findings related to study medication dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wasim Khan, MD | Acrotech Biopharma Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Wayne Cancer Institute @ Providence Saint John's Health Center | Santa Monica | California | 90404 | United States | ||
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C487081 | belinostat |
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Assess Safety of belinostat in patients with wild type, heterozygous, and homozygousUGT1A1*28 genotypes |
| 26 Weeks |
| The Oncology Institute of Hope and Innovation |
| Whittier |
| California |
| 90603 |
| United States |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States |