MGCD0103 Administered in Combination With Azacitidine (Vidaza®) to Subjects With Relapsed or Refractory Hodgkin or Non-Hodgkin Lymphoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

March 31, 2009

Study Completion Date

March 31, 2009

Conditions
Hodgkin LymphomaNon-Hodgkin Lymphoma (Follicular or Large Diffuse B-cell Lymphoma or Mantle Cell Lymphoma)
Interventions
DRUG

MGCD0103 and Azacitidine

"In Part 1 of the study, up to 22 people to enroll will receive a single, oral dose (75 mg gelcap) of MGCD0103 and FB-MGCD0103 during their first 2 weeks in the study. Up to 22 additional people will receive a single dose of both MGCD0103 and TA-FB-MGCE0103. The next group of people to enroll will receive 2 different single doses (25, 50, 100 mg) of FB-MGCD0103 or TA-FB-MGCD0103 during their first 2 weeks in the study.~In Part 2 of the study, from Day 1-5 of each 28-day cycle, all subjects will receive a dose of azacitidine (75 mg/m2) either subcutaneously or through an intravenous device, and on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, a single, oral dose (85 mg) of MGCD0103 until progression or unacceptable toxicity develops."

Trial Locations (4)

46107

St. Francis Cancer Research Foundation, Beech Grove

77030

University of Texas, MD Anderson, Houston

89135

Nevada Cancer Institute, Las Vegas

Unknown

Weill Medical College of Cornell University, New York

Sponsors
All Listed Sponsors
lead

Mirati Therapeutics Inc.

INDUSTRY

NCT00543582 - MGCD0103 Administered in Combination With Azacitidine (Vidaza®) to Subjects With Relapsed or Refractory Hodgkin or Non-Hodgkin Lymphoma | Biotech Hunter | Biotech Hunter