Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)
The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for belinostat when combined with CHOP regimen and establish the recommended belinostat dose for the Phase 3 study.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Dose Finding Study of Belinostat Plus Cyclophosphamide/Vincristine/Doxorubicin/Prednisone (CHOP) Regimen (BelCHOP) for Treatment of Patients With Peripheral T-cell Lymphoma(PTCL)|
- Maximum Tolerated Dose (MTD) [ Time Frame: up to 5 days ] [ Designated as safety issue: Yes ]To determine the MTD for belinostat when combined with CHOP regimen and establish the Phase 3 recommended belinostat dose.
- Safety and tolerance [ Time Frame: up to 5 days ] [ Designated as safety issue: Yes ]To assess safety and tolerance of belinostat when given in combination with CHOP regimen. Safety and tolerance will be mainly characterized by the number and severity of treatment emergent adverse events, and treatment related AEs that occur or worsen after the first dose of study treatment.
- Overall Response Rate [ Time Frame: 126 days ] [ Designated as safety issue: Yes ]Overall response rate (ORR) after 6 cycles of BelCHOP regimen
- Effectiveness of study drug [ Time Frame: 126 days ] [ Designated as safety issue: Yes ]Pharmacokinetics of belinostat when co-administered with CHOP regimen. The concentration of Belinostat to assess the effectiveness.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Dose Finding Phase
This is a Phase 1 dose finding study using the traditional escalation rule of 3+3 design to evaluate the Maximum Tolerated Dose of Belinostat when administered in combination with CHOP. In Part A of the study, up to three sequential dose cohorts will enroll a maximum of 6 patients each.
Enrollment will begin with the enrollment of patients into Cohort 3.
On Day 1 of each 21-day treatment cycle, the study treatment will start with belinostat followed by CHOP regimen.
Belinostat will be administered by intravenous infusion once daily for up to 5 days depending on the dose cohort as follows:
Other Name: PXD101Drug: CHOP
Cyclophosphamide - 750 mg/m2 - IV - Day 1
Vincristine - 1.4 mg/m2 - IV - Day 1
Doxorubicin - 50mg/m2 - IV - Day 1
Prednisone 100mg PO - On Day 1 Prednisone will be administered after chemotherapy part of CHOP, and on Day 2-5 after belinostat.
This is a Phase 1 dose finding study using the traditional escalation rule of 3+3 design to evaluate the Maximum Tolerated Dose (MTD) of belinostat when administered in combination with CHOP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01839097
|Contact: Denise Uyemail@example.com|
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|Study Director:||Mi Rim Choi, MD||Spectrum Pharmaceuticals, Inc|