Spots Global Cancer Trial Database for A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF

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Trial Identification

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

Official Title: 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

Study ID: NCT01787552

Conditions

Primary Myelofibrosis

Thrombocytosis

Essential Thrombocythemia

Polycythemia Vera

Myeloproliferative Disorders

Bone Marrow Diseases

Hematologic Diseases

Blood Coagulation Disorders

Blood Platelet Disorders

Hemorrhagic Disorders

Interventions

LDE225

INC424

Study Description

Brief 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.