Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

PHASE2TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Acute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)
Interventions
DRUG

Azacitidine

75 mg/m2/day for 5 days, subcutaneous (SC) injection, Days 1 - 5 of every 28-day cycle

DRUG

MGCD0103

90 mg, oral (PO) administration, 3 times per week for 12 doses, 28-day cycle

DRUG

MGCD0103

90 mg, oral (PO) administration, 3 times per week for 10 doses, 28-day cycle

Trial Locations (8)

77030

MD Anderson Cancer Center, Houston

V5Z 4E3

Diamond Centre, Leukemia/BMT Program of BC, Vancouver

H3T 1E2

Jewish General Hospital, Montreal

B15 2TH

University Hospital, Birmingham

BH7 7DW

Royal Bournemouth Hospital, Bournemouth

EC1A 7BE

St. Bartholomews Hospital, London

SE5 9RS

Kings College Hospital, London

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors
All Listed Sponsors
lead

Mirati Therapeutics Inc.

INDUSTRY

NCT00666497 - Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) | Biotech Hunter | Biotech Hunter