NCT01839097

Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Acrotech Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Belinostat	Belinostat will be administered by intravenous infusion once daily for up to 5 days depending on the dose cohort as follows: * Cohort 1: belinostat 1000 mg/m2 IV on Day 1 * Cohort 2: belinostat 1000 mg/m2 IV on Day 1-2 * Cohort 3: belinostat 1000 mg/m2 IV on Day 1-3 * Cohort 4: belinostat 1000 mg/m2 IV on Day 1-4 * Cohort 5: belinostat 1000 mg/m2 IV on Day 1-5
DRUG	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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-04-24
• Last updated: 2020-01-03

Locations

8 sites across 1 country: United States