Study of MGCD0103 Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma - Full Text View

Sponsors and Collaborators:	Celgene Corporation MethylGene Inc.
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00359086

Purpose

In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with relapsed and refractory lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: MGCD0103	Phase II

MedlinePlus related topics: Lymphoma

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of MGCD0103 (MG-0103) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Response rate [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: Yes ]
Duration of objective response [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
Safety profile [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: Yes ]
Pharmacokinetics [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
Pharmacodynamics [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]

Estimated Enrollment:	82
Study Start Date:	August 2006
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: MGCD0103 MGCD0103 given orally three times per week

Eligibility

Criteria

Inclusion Criteria:

Pathologic confirmation of relapsed or refractory lymphoma.
1. DLBCL stage II-IV
2. Follicular lymphoma
At least one site of measurable disease (≥ 2.0 cm with conventional techniques; physical exam [PE], CT, X-ray, MRI).
Prior treatment:
1. DLBCL cohort: Disease progression following initial therapy and transplant (unless the patient is ineligible or refused transplant). There is no limit to number of prior therapies.
2. Follicular lymphoma cohort: Disease progression on or following initial therapy. There is no limit to number of prior therapies.
ECOG performance status of 0 or 1.
Aged 18 years or older.
Laboratory requirements.

Exclusion Criteria:

Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia [CIN/cervical in situ] or melanoma in situ). Prior history of cancer is allowed, as long as there is no active disease.
Pregnant or lactating women.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359086

Locations

United States, North Carolina
Duke University Adult Bone Marrow Transplant Clinic
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Sir Mortimer Davis-Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Charles LeMoyne Hospital
Greenfield Park, Quebec, Canada, J4V 2H1
Universite de Sherbrooke, Service d'hematologie
Sherbrooke, Quebec, Canada, J1H 5N4

Sponsors and Collaborators

Celgene Corporation

MethylGene Inc.

Investigators

Study Director:

Robert Martell

MethylGene Inc.

More Information

Responsible Party:	MethylGene, Inc. ( Tracy-Ann Patterson, Project Manager )
Study ID Numbers:	MGCD0103-008
Study First Received:	July 31, 2006
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00359086
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Celgene Corporation:

Relapsed and Refractory Lymphoma
Phase II

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009