This trial is active, not recruiting.

Condition peripheral t-cell lymphoma
Treatment pxd101
Phase phase 2
Target HDAC
Sponsor Spectrum Pharmaceuticals, Inc
Collaborator TopoTarget A/S
Start date December 2008
End date March 2014
Trial size 129 participants
Trial identifier NCT00865969, 2008-005843-40, PXD101-CLN-19


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Belinostat (PXD101) 1000 mg/m²administered as a 30 minute IV infusion
pxd101 Belinostat
Belinostat (PXD101) 1000 mg/m²administered as a 30 minute IV infusion on days 1-5 of every 3-week cycle

Primary Outcomes

Primary - Objective response rate
time frame: December 2010

Secondary Outcomes

Safety, further efficacy parameters (e.g. time to response, duration of response, time to progression, and survival), and population pharmacokinetics
time frame: December 2010

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
Principal investigator Peter Brown, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Spectrum Pharmaceuticals, Inc.