drugset / Trial / NCT01456676

Nilotinib and LDE225 in the Treatment of Chronic or Accelerated Phase Myeloid Leukemia in Patients Who Developed Resistance to Prior Therapy

NCT01456676

Phase 1 Completed 11 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the feasibility of administering the combination of nilotinib and LDE225 to patients with chronic or accelerated phase of 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.

Timeline

Start
2012-01
Primary completion
2014-02
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Nilotinib Small molecule 400 mg
Subject Sonidegib Small molecule 400 mg Oral
Subject Sonidegib Small molecule 800 mg Oral