At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
LDE225 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ib/II, Open-label, Multi-center, Dose-finding Study to Assess the Safety and Efficacy of the Oral Combination of LDE225 and INC424 (Ruxolitinib) in Patients With Myelofibrosis
In Brief
A Phase 2 clinical trial evaluating LDE225 and INC424 for Primary Myelofibrosis and 9 related conditions. Completed, enrolled 50 participants across 18 sites in 11 countries.
Detailed Summary
The purpose of this phase Ib/II clinical trial was to: a) evaluate the safety of the co-administration of LDE225 and INC424 in myelofibrosis patients and establish a maximum tolerated dose and/or Recommended Phase II dose of the combination and b) to assess the efficacy of the co-administration of LDE225 and INC424 on spleen volume reduction.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Myelofibrosis, Thrombocytosis, Essential Thrombocythemia, Polycythemia Vera, Myeloproliferative Disorders, Bone Marrow Diseases, Hematologic Diseases, Blood Coagulation Disorders, Blood Platelet Disorders, Hemorrhagic Disorders
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2013
Enrollment StartMay 2013
Primary CompletionApr 2018
TodayJul 2026
First PostedFeb 8, 2013
Enrollment StartMay 8, 2013
Primary CompletionApr 10, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.4 years ago
Interventions
LDE225drug
INC424drug