NCT01787552

A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is considered to have been completed because the participants completed the study as per study design at the time of trial termination. If participants were already in extension phase until discontinuation criteria were met or alternative setting was available, they were considered as completed. The study was terminated due to one of the compounds being divested.

Conditions

• Primary Myelofibrosis
• Thrombocytosis
• Essential Thrombocythemia
• Polycythemia Vera
• Myeloproliferative Disorders
• Bone Marrow Diseases
• Hematologic Diseases
• Blood Coagulation Disorders
• Blood Platelet Disorders
• Hemorrhagic Disorders

Interventions

Type	Name	Description
DRUG	LDE225
DRUG	INC424

Timeline

• Start date: 2013-05-08
• Primary completion: 2018-04-10
• Completion: 2018-04-10
• First posted: 2013-02-08
• Last updated: 2020-04-15
• Results posted: 2020-04-15

Locations

18 sites across 11 countries: Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom