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: May 8, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 19, 2009

Last Updated Date

May 8, 2013

Start Date ^ICMJE

December 2008

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00865969 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

Official Title ^ICMJE

A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Peripheral T-cell Lymphoma

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Belinostat

Belinostat (PXD101) 1000 mg/m²administered as a 30 minute IV infusion

Intervention: Drug: PXD101

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

129

Estimated Completion Date

September 2013

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, Croatia, Denmark, France, Germany, Hungary, Italy, Netherlands, Slovakia, South Africa, Spain

Administrative Information

NCT Number ^ICMJE

NCT00865969

Other Study ID Numbers ^ICMJE

PXD101-CLN-19, 2008-005843-40

Has Data Monitoring Committee

Yes

Responsible Party

Spectrum Pharmaceuticals, Inc

Study Sponsor ^ICMJE

Spectrum Pharmaceuticals, Inc

Collaborators ^ICMJE

TopoTarget A/S

Investigators ^ICMJE

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

Information Provided By

Spectrum Pharmaceuticals, Inc

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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