A Single-arm Dose-finding Phase Ib Multicenter Study of the Oral Smoothened Antagonist LDE225 in Combination With Nilotinib in Chronic or Accelerated Phase of Chronic Myeloid Leukemia Patients Who Have Failed Prior Therapy With Other BCR-ABL Tyrosine-kinase Inhibitors
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence rate and category of dose limiting toxicities (DLTs) during the first two cycles of therapy
Determination of the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of nilotinib in combination with LDE225
56 days (2 treatment cycles at 28 days each)
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CAMN107Y2101
NCT01456676
January 2012
September 2016
Name | Location |
---|---|
Oregon Health & Science University Dept. Hematologic Malignancies | Portland, Oregon 97239 |
MD Anderson Cancer Center/University of Texas UT MD Anderson | Houston, Texas 77030-4009 |