Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
TopoTarget A/S
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00865969
First received: March 19, 2009
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to assess efficacy and safety of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.


Condition Intervention Phase
Peripheral T-cell Lymphoma
Drug: PXD101
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Primary - Objective response rate [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, further efficacy parameters (e.g. time to response, duration of response, time to progression, and survival), and population pharmacokinetics [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: December 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belinostat
Belinostat (PXD101) 1000 mg/m²administered as a 30 minute IV infusion
Drug: PXD101
Belinostat (PXD101) 1000 mg/m²administered as a 30 minute IV infusion on days 1-5 of every 3-week cycle
Other Name: Belinostat

Detailed Description:

This is an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy.

Approximately 120 patients will be enrolled. Patients will be treated with 1000 mg/m² belinostat administered as a 30-minute IV infusion on days 1-5 of every 3-week cycle until there is disease progression or unmanageable treatment-related toxicities.

The primary study endpoint is objective response rate (ORR) based on the IHP revision IWG criteria. Safety will be evaluated during the study and for 30 days after the last administration of study drug. Adverse events and laboratory studies will be graded according to NCI-CTCAE v. 3.0.

  Eligibility

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

Inclusion criteria:

  • A histologically confirmed diagnosis of PTCL
  • Patients must have relapsed or refractory disease after at least one prior systemic anticancer regimen. Systemic anticancer therapy is defined as chemotherapy or immunotherapy administered systemically.
  • Patients must have at least one site of disease measurable in two dimensions by computed tomography (CT).
  • Age ≥ 18 years.
  • Adequate bone marrow, liver, and renal functions.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Negative pregnancy test for women of childbearing potential.

Exclusion criteria:

  • Relapse within 100 days of autologous or allogeneic bone marrow transplant.
  • Prior HDAC inhibitor therapy.
  • Co-existing active infection or any medical condition likely to interfere with trial procedures.
  • Severe cardiovascular disease.
  • Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.
  • Active concurrent malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix).
  • Symptomatic or untreated central nervous system (CNS) metastases.
  • Pregnant or breast-feeding women.
  • Known infection with HIV, hepatitis B or hepatitis C.
  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: NCT00865969

  Show 117 Study Locations
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
TopoTarget A/S
Investigators
Principal Investigator: Peter Brown, MD H:S Rigshospitalet, Department of Hematology, Denmark
Principal Investigator: Pier L Zinzani, MD Università di Bologna, Italy
Principal Investigator: André Bosly, MD Cliniques Universitaires UCL Mont Godinne, Belgium
Principal Investigator: Georges Fillet, MD University of Liege, Belgium
Principal Investigator: Eric van den Neste, MD Clinique Universitaier Saint Luc, Belgium
Principal Investigator: Nicolas Monier, MD Hôpital de l'Archet 1 Centre Hospitalier Universitaire (CHU) de Nice, France
Principal Investigator: Elisabeth Perez, MD Groupe Hospitalier Sud Réunion, France
Principal Investigator: Maria Delioukina, MD City of Hope National Medical Center, USA
Principal Investigator: Adam Lerner, MD Boston Medical Center, USA
Principal Investigator: Lydia Dreosti, MD Pretoria Academic Hospital, South Africa
Principal Investigator: D. Moodley, MD Drs Pirjol, Szpak and Moodley Inc, Durban, South Africa
Principal Investigator: Hanneke C. Kluin-Nelemans, MD University Medical Center Groningen UMCG, The Netherlands
Principal Investigator: G. Sissolak, MD Tygerberg Hospital, Cape Town, South Africa
Principal Investigator: L. Verdonk, MD Isala Clinics, Zwolle, The Netherlands
Principal Investigator: O. Visser, MD VU Medical Center, Amsterdam, The Netherlands
Principal Investigator: Owen A. O'Connor, MD New York University Cancer Institute, USA
Principal Investigator: Sarit Assouline, MD McGill University, Department of Oncology Clinical Research Program, Montreal, Canada
Principal Investigator: Juan Manuel Sancho Cia, MD ICO Hospital Germans Trias i Pujol, Badalona, Spain
Principal Investigator: Consolación Rayon, MD Hospital Universitario Central de Asturias, Oviedo, Spain
Principal Investigator: Sonia Gonzales, MD Hospital Clinico Universitario de Santiago, Santiago de Compostella, Spain
Principal Investigator: Lorenz Trümper, MD Universität Göttingen, Abteilung Hämatologie und Onkologie, Göttingen, Germany
Principal Investigator: Andreas Viardot, MD Universitätsklinikum Ulm, Ulm, Germany
Principal Investigator: Georg Hess, MD Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany
Principal Investigator: Hans-Heinrich Wolf, MD Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg, Halle, Germany
Principal Investigator: Andreas Neubauer, MD University Hospital Marburg, Marburg, Germany
Principal Investigator: Michele Frank, MD Cascade Cancer Center
Principal Investigator: Madeleine Duvic, MD UT - M. D. Anderson Cancer Center
Principal Investigator: Andrei Shustov, MD Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
Principal Investigator: Melissa Runge-Morris, MD Karmanos Cancer Institute
Principal Investigator: Nalini Janakiraman, MD Henry Ford Health System
Principal Investigator: Amanda Cashen, MD Wasington University School of Medicine- Division of Oncology
Principal Investigator: Beata Holkova, MD Massey Cancer Center
Principal Investigator: Mohammad Tirgan, MD Hematology Associates
Principal Investigator: Bernard Poiesz, MD Upstate Medical Univeristy Syracuse
Principal Investigator: Charles Farber, MD Morristown Memorial Hospital
Principal Investigator: Zale Bernstein, MD Erie County Medical Center (Roswell Park)
Principal Investigator: Ralph Boccia, MD Center for Cancers and Blood Disorders
Principal Investigator: David Grinblatt, MD Kellogg Cancer Care Center
Principal Investigator: Laura Blakely, MD Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
Principal Investigator: David Dennis, MD Boca Raton Clinical Research Associates
Principal Investigator: Fernando Camacho, MD Bronx River Medical Associates, PC
Principal Investigator: Eliot Epner, MD Penn State Hershey Cancer Institute
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00865969     History of Changes
Other Study ID Numbers: PXD101-CLN-19, 2008-005843-40
Study First Received: March 19, 2009
Last Updated: February 11, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Croatia: Agency for Medicinal Product and Medical Devices
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Spectrum Pharmaceuticals, Inc:
Belinostat
peripheral T-cell lymphoma
PXD101
PTCL
HDAC inhibitor
histone deacetylase inhibitor

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Belinostat
Histone Deacetylase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014