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:||October 2014|
|Estimated Primary Completion Date:||October 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.
|Contact: William Lefirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama, Birmingham||Recruiting|
|Birmngham, Alabama, United States, 35294|
|Contact: Brittany Hamby, RN, BSN, OCN 205-934-0314 email@example.com|
|Principal Investigator: Naresh Bellam, MD|
|United States, Georgia|
|Northeast Georgia Cancer Care, LLC||Recruiting|
|Athens, Georgia, United States, 30607|
|Contact: Jamie Hodgson, CCRC 706-353-2990 firstname.lastname@example.org|
|Principal Investigator: Petros Nikolinakos, MD|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Michelle Amundson 507-293-1933 Amundson.email@example.com|
|Principal Investigator: Patrick B Johnston, MD, PhD|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Sarah Larson 314-362-3257 firstname.lastname@example.org|
|Principal Investigator: Amanda Cashen, MD|
|United States, New Jersey|
|John Theurer Cancer Center at Hackensack University Medical Center||Recruiting|
|Hackensack, New Jersey, United States, 07601|
|Contact: Marisa Valentinetti, RN 551-996-5900 MValentinetti@HackensackUMC.org|
|Principal Investigator: Tatyana Feldman, MD|
|Hematology - Oncology Associates of Northern NJ P.A||Recruiting|
|Morristown, New Jersey, United States, 07962|
|Contact: Michelle Mackenzie, RN 973-538-3593 email@example.com|
|Principal Investigator: Charles M Farber, Md, PhD|
|United States, New York|
|Columbia University Medical Center/Center for Lymphiod Malignancies||Recruiting|
|New York, New York, United States, 10019|
|Contact: Danielle Wright 212-326-5731 Dw2316@columbia.edu|
|Principal Investigator: Jasmine Zain, MD|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Peggy Alton 919-681-4769 Peggy.firstname.lastname@example.org|
|Principal Investigator: Anne Beaven, MD|
|Study Director:||Mi Rim Choi, MD||Spectrum Pharmaceuticals, Inc|