Ignite Creation Date:
2024-05-06 @ 8:09 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02680795
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2016-02-09
Brief Title:
Establish the PK of Belinostat in Patients With Wild-type Heterozygous and Homozygous UGT1A128 Genotypes
Sponsor:
Acrotech Biopharma Inc
Organization:
Acrotech Biopharma Inc
Study Overview
Official Title:
Open-label Nonrandomized Phase 1 Study Evaluating Safety and Pharmacokinetics of Belinostat in Patients With RelapsedRefractory Solid Tumors or Hematological Malignancies in Wild-Type Heterozygous and Homozygous UGT1A128 Genotypes
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 open-label nonrandomized study to determine the PK profiles of belinostat in patients with relapsedrefractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A128 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
Detailed Description:
This is a Phase 1 open-label nonrandomized study to determine the PK profiles of belinostat in patients with relapsedrefractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A128 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None