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

Phase 1

Completed

• Conditions: Peripheral T-cell Lymphoma
• Interventions: Drug: Belinostat; Drug: CHOP

• Registration Number: NCT01839097
• Lead Sponsor: Acrotech Biopharma Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-19
• Study First Posted: 2013-04-24
• Study Start: 2013-05
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-31
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Age 18 years or above
• Life Expectancy > 3 months
• Histologically confirmed diagnosis of PTCL
• Patients with transformed CTCL eligible for CHOP regimen
• Measurable disease based on Cheson 2007 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status < 2

Exclusion Criteria

• Known active Hepatitis B/ Hepatitis C/ HIV infection
• Known, uncontrolled CNS metastases or primary CNS lymphoma
• Deep vein thrombosis diagnosed within 3 months
• Ongoing treatment for pre-existing cardiovascular disease
• Neuropathy Grade 3 or more
• Previous extensive radiotherapy except limited field RT for locally advanced nasal NK PTCL or for pain palliation
• Prior therapy with severely myelotoxic regimens, including autologous and allogenic stem cell transplantation
• Prior therapy with HDAC inhibitors (except for CTCL)
• Inadequate hematological, hepatic, or renal function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Finding Phase	CHOP	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.
Dose Finding Phase	Belinostat	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.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	up to 5 days	To determine the MTD for belinostat when combined with CHOP regimen and establish the Phase 3 recommended belinostat dose.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	126 days	Overall response rate (ORR) after 6 cycles of BelCHOP regimen
Safety and tolerance	up to 5 days	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.
Effectiveness of study drug	126 days	Pharmacokinetics of belinostat when co-administered with CHOP regimen. The concentration of Belinostat to assess the effectiveness.

Trial Locations

Locations (8)

Hematology - Oncology Associates of Northern NJ P.A; 🇺🇸 Morristown, New Jersey, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

John Theurer Cancer Center at Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Northeast Georgia Cancer Care, LLC; 🇺🇸 Athens, Georgia, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Columbia University Medical Center/Center for Lymphiod Malignancies; 🇺🇸 New York, New York, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States