PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)

PHASE1/PHASE2CompletedINTERVENTIONAL

Enrollment

144

Participants

Timeline

Start Date

January 30, 2002

Primary Completion Date

March 27, 2008

Study Completion Date

March 27, 2008

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndromes

Interventions

DRUG

Itraconazole

Itraconazole was commercially available.

DRUG

PKC412

PKC412 was supplied as soft gelatin capsules containing 25 mg PKC412.

Trial Locations (4)

New York Weill Cornell Medical Center, New York

Memorial Sloan Kettering Cancer Center, New York

UCLA Medical Center, Los Angeles

Dana-Farber Cancer Institute, Boston