Clinical Trial of PXD101 in Patients With T-Cell Lymphomas

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

TopoTarget A/S

ClinicalTrials.gov Identifier:

NCT00274651

First received: January 10, 2006

Last updated: December 18, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 10, 2006
Last Updated Date	December 18, 2012
Start Date ^ICMJE	January 2006
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 21, 2007)	To determine the efficacy of PXD101 treatment as measured by objective response rate, in patients with recurrent or refractory cutaneous T-cell lymphoma (CTCL). [ Time Frame: throughout the study ] [ Designated as safety issue: No ] To determine the efficacy of PXD101 treatment as measured by objective response rate, in patients with recurrent or refractory T-cell lymphoma (PTCL) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00274651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 21, 2007)	To determine duration of response, time to response and time to progression following PXD101 therapy [ Time Frame: throughout the study ] [ Designated as safety issue: No ] to assess safety following PXD101 therapy in PTCL and CTCL populations [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Trial of PXD101 in Patients With T-Cell Lymphomas
Official Title ^ICMJE	A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas
Brief Summary	This is an open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cutaneous T-Cell Lymphoma Peripheral T-Cell Lymphoma Non-Hodgkin's Lymphoma
Intervention ^ICMJE	Drug: belinostat 1000 mg/m2 for 5 days every 21 days; IV Other Name: PXD101
Study Arm (s)	Experimental: Arm A CTCL patients will receive 1000 mg/m2 of PXD101 IV Intervention: Drug: belinostat Experimental: Arm B PTCL patients will receive 1000 mg/m2 of PXD101 IV Intervention: Drug: belinostat
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	Completed
Enrollment ^ICMJE	53
Completion Date	July 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female with age > or = to 18 years. histologically confirmed diagnosis of cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) or other T-cell non-Hodgkin's lymphoma (NHL). Must have failed at least one line of prior systemic therapy. No limitation in number of prior therapies. CTCL patients who are refractory or intolerant to oral Targretin are also eligible. The presence of measurable disease (defined as > or = to 1 cm with radiographic imaging) for PTCL or stage 1B or greater disease for CTCL and assessable by the severity-weighted assessment tool (SWAT). Adequate bone marrow and hepatic function including the following: Absolute neutrophil count > or = to 1,000 cells/mm3, platelets > or = to 40,000/mm3 Total bilirubin < or = to 1.5 x upper normal limit or < or = 3 x upper normal limit if hepatic involvement AST (SGOT) (aspartate aminotransferase), ALT (SGPT) (alanine aminotransferase) < or = to 2.5 x upper normal limit (< or = 5 x upper normal limit if hepatic involvement) Hemoglobin > or = 9.0 g/dL. Serum potassium within normal range. Karnofsky performance status > or = to 70%. Estimated life expectancy > 3 months. Signed informed consent approved by the Institutional Review Board (IRB). Exclusion Criteria: Patients who have received anti-cancer therapies within 4 weeks of first PXD101 administration should be excluded unless toxicity from prior anti-cancer therapy has resolved or returned to baseline and cancer disease status warrants. Any use of investigational drugs within 4 weeks prior to study registration. Major surgery within 4 weeks of study drug administration. Prior allogeneic bone marrow transplant. A diagnosis of adult T-cell lymphoma/leukemia (ATLL) or precursor T-lymphoblastic lymphoma. Co-existing active infection or any co-existing medical condition likely to interfere with trial procedures. However, patients with progressing CTCL whose open skin lesions are frequently infected may not be excluded from this trial at the discretion of Investigators. Clinically significant cardiovascular disease left or ventricular ejection fraction < 40% (by echocardiogram [ECHO] or multigated acquisition scan [MUGA]) within 3 months of study enrollment. A marked baseline prolongation of QT/QTc ((corrected) QT) interval. Patients with renal insufficiency defined as a calculated creatinine clearance of < 45 mL/min/1.73 m2. Patients with a history of allergic reactions attributed to compounds of similar chemical or biological composition to PXD101 and L-arginine. 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. Patients requiring treatment for other malignant diseases or less than 5 years post-treatment completion for an invasive malignant disease (excluding non-melanotic skin cancers or cervical cancer in-situ). Patients with any history of melanoma should be excluded. Pregnant or breast-feeding women, and women of childbearing age and potential, who are not willing to use effective contraception. Male patients and/or their fertile female partners who are not willing to use contraceptives during the trial. Known infection with HIV, human T-cell leukemia virus type-1 (HTLV-1), hepatitis B or hepatitis C.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, France, Germany, Israel, Thailand

Administrative Information
NCT Number ^ICMJE	NCT00274651
Other Study ID Numbers ^ICMJE	PXD101-CLN-6
Has Data Monitoring Committee	No
Responsible Party	TopoTarget A/S
Study Sponsor ^ICMJE	TopoTarget A/S
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	TopoTarget A/S
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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