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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Spectrum Pharmaceuticals, Inc
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01839097
First received: April 9, 2013
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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: 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)

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 ] [ Designated as safety issue: Yes ]
    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 ] [ 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.


Estimated Enrollment: 28
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01839097

Contacts
Contact: Denise Uy 949-743-9303 denise.uy@sppirx.com

Locations
United States, Alabama
University of Alabama, Birmingham Withdrawn
Birmngham, Alabama, United States, 35294
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
Contact: Stephanie Stellars         
Principal Investigator: Francine Foss, MD         
United States, Georgia
Northeast Georgia Cancer Care, LLC Recruiting
Athens, Georgia, United States, 30607
Contact: Jamie Hodgson, CCRC         
Principal Investigator: Petros Nikolinakos, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michelle Amundson         
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         
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         
Principal Investigator: Tatyana Feldman, MD         
Hematology - Oncology Associates of Northern NJ P.A Recruiting
Morristown, New Jersey, United States, 07962
Contact: Michelle Mackenzie, RN         
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         
Principal Investigator: Jasmine Zain, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Peggy Alton         
Principal Investigator: Anne Beaven, MD         
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Director: Mi Rim Choi, MD Spectrum Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01839097     History of Changes
Other Study ID Numbers: SPI-BEL-12-104
Study First Received: April 9, 2013
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Spectrum Pharmaceuticals, Inc:
PTCL
Maximum Tolerated Dose
Belinostat

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Belinostat
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Glucocorticoids
Histone Deacetylase Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on November 24, 2014