Clinical Trial reference link:
NCT01456676You are here
Nilotinib and LDE225 in the Treatment of Chronic or Accelerated Phase Myeloid Leukemia in Patients Who Developed Resistance to Prior Therapy
Nilotinib and LDE225 in the Treatment of Chronic or Accelerated Phase Myeloid Leukemia in Patients Who Developed Resistance to Prior Therapy
Recruitment period:
1 January 2012 to 1 February 2014Trial period:
1 January 2012 to 1 February 2014Treatments:
For newly diagnosed patients:
noThis trial has been completed
Verified: April 2014
Sponsor: Novartis Pharmaceuticals
Last updated: September 30, 2012
Phase 1 study: Nilotinib and LDE225 in the Treatment of Phase Chronic Myeloid Leukemia Patients Who Developed Resistance to Prior Therapy
Official Title ICMJE: A Single-arm Dose-finding Phase Ib Multicenter Study of the Oral Smoothened Antagonist LDE225 in Combination With Nilotinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Have Failed Prior Therapy With Other BCR-ABL Tyrosine-kinase Inhibitors
Brief Summary
The purpose of this study is to determine the feasibility of administering the combination of nilotinib and LDE225 to patients with phase chronic myeloid leukemia and to establish the maximum tolerated dose (MTD) and/or recommended Phase II dose level (RP2D) of LDE225 in combination with nilotinib.