WHO ICTRP trial

A Study to Evaluate the Efficacy and Safety of Vismodegib in Combination with…

EUCTR2015-001620-33-DE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2015-001620-33-DE
Public title A Study to Evaluate the Efficacy and Safety of Vismodegib in Combination with Ruxolitinib versus Placebo and Ruxolitinib in Patients with Intermediate- or High-Risk Myelofibrosis
Scientific title A Phase Ib/III, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of vismodegib in combination with ruxolitinib versus placebo and ruxolitinib in patients with intermediate- or high-risk myelofibrosis
Primary sponsor F. Hoffmann-La Roche Ltd.
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries France;United States;Canada;Germany;Italy
Conditions Intermediate- or high-risk myelofibrosis MedDRA version: 19.1 Level: PT Classification code 10028537 Term: Myelofibrosis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area…
Interventions Trade Name: Erivedge Pharmaceutical Form: Capsule, hard INN or Proposed INN: vismodegib CAS Number: 879085-55-9 Other descriptive name: VISMODEGIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150…
Registration date Sep 16, 2015
Target size 104
Secondary IDs WO29806
Registry page clinicaltrialsregister.eu

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