An Open-Label, Phase I/II Study of Nilotinib (Tasigna) and MEK-162 (ARRY-162) Used in Combination for Patients With Refractory or Advanced Chronic Myeloid Leukemia and Philadelphia Positive Acute Leukemia (Protocol CAMN107AUS41T)

PHASE1TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

March 11, 2015

Primary Completion Date

February 2, 2017

Study Completion Date

February 2, 2017

Conditions
Leukemia
Interventions
DRUG

MEK-162

"Phase 1: Advanced CML + Philadelphia positive Acute Leukemia-Group 1 Starting Dose of MEK-162: 30 mg by mouth twice a day on starting on Day 1 of a 28 day cycle.~Phase 2 Advanced CML + Philadelphia positive Acute Leukemia-Group 1 Starting dose of MEK-162: MTD from Phase 1 to be taken by mouth twice a day starting on on Day 1 of a 28 day cycle.~Phase 1 Chronic Phase CML - Group 2 Starting dose of MEK-162: 30 mg by mouth twice a day of a 28 day cycle.~Phase 2 Chronic Phase CML - Group 2 Starting Dose of MEK-162: MTD from Phase 1 by mouth twice a day starting on Day 8 of a 28 day cycle."

DRUG

Nilotinib

"Phase 1 Advanced CML + Philadelphia positive Acute Leukemia-Group 1 Starting Dose of Nilotinib: 400 mg by mouth twice a day of a 28 day cycle.~Phase 2 Advanced CML + Philadelphia positive Acute Leukemia-Group 1 Starting dose of Nilotinib: MTD from Phase 1 to be taken by mouth twice a day starting on Day 2 of a 28 day cycle.~Phase 1 Chronic Phase CML - Group 2 Starting dose of Nilotinib: 400 mg by mouth twice a day of a 28 day cycle.~Phase 2 Chronic Phase CML - Group 2 Starting Dose of Nilotinib: MTD from Phase 1 by mouth twice a day starting on Day 1 of a 28 day cycle."

BEHAVIORAL

Questionnaires

Questionnaires completed and the end of cycle 1, 2, 3, 6, 9, and 12.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Array BioPharma

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER