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Trial record 1 of 1 for:    SPI-BEL-12-104
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Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)

This study has been completed.
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc Identifier:
First received: April 9, 2013
Last updated: April 18, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Peripheral T-cell Lymphoma
Drug: Belinostat
Drug: CHOP
Phase 1

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 23
Study Start Date: May 2013
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
Other Name: PXD101
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.

Other Names:
  • Cyclophosphamide
  • Vincristine
  • Doxorubicin
  • Prednisone

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01839097

United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Georgia
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States, 30607
United States, Minnesota
Mayo Clinic
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
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Study Director: Mi Rim Choi, MD Spectrum Pharmaceuticals, Inc
  More Information

Responsible Party: Spectrum Pharmaceuticals, Inc Identifier: NCT01839097     History of Changes
Other Study ID Numbers: SPI-BEL-12-104
Study First Received: April 9, 2013
Last Updated: April 18, 2016

Keywords provided by Spectrum Pharmaceuticals, Inc:
Maximum Tolerated Dose

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents processed this record on April 26, 2017