Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01839097|
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : April 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Peripheral T-cell Lymphoma||Drug: Belinostat Drug: CHOP||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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: PXD101
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.
- Maximum Tolerated Dose (MTD) [ Time Frame: up to 5 days ]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 ]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 ]Overall response rate (ORR) after 6 cycles of BelCHOP regimen
- Effectiveness of study drug [ Time Frame: 126 days ]Pharmacokinetics of belinostat when co-administered with CHOP regimen. The concentration of Belinostat to assess the effectiveness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839097
|United States, Connecticut|
|New Haven, Connecticut, United States, 06511|
|United States, Georgia|
|Northeast Georgia Cancer Care, LLC|
|Athens, Georgia, United States, 30607|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|United States, New Jersey|
|John Theurer Cancer Center at Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|Hematology - Oncology Associates of Northern NJ P.A|
|Morristown, New Jersey, United States, 07962|
|United States, New York|
|Columbia University Medical Center/Center for Lymphiod Malignancies|
|New York, New York, United States, 10019|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Study Director:||Mi Rim Choi, MD||Spectrum Pharmaceuticals, Inc|