NCT02593760View on ClinicalTrials.gov

A Study to Evaluate the Efficacy and Safety of Vismodegib in Combination With Ruxolitinib for the Treatment of Intermediate- or High-Risk Myelofibrosis (MF)

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

January 25, 2016

Primary Completion Date

March 29, 2017

Study Completion Date

July 12, 2017

Conditions
Myelofibrosis
Interventions
OTHER

Placebo

Placebo will be administered PO QD for up to 48 weeks.

DRUG

Ruxolitinib

Ruxolitinib will be administered PO BID at a starting dose depending on the participants's baseline platelet count for up to 48 weeks.

DRUG

Vismodegib

Vismodegib will be administered at a dose of 150 mg PO QD for up to 48 weeks.

Trial Locations (13)

10126

A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia, Turin

13353

Campus Virchow-Klinikum Charité Centrum 14; Medizinische Klinik m.S. Hämatologie u. Onkologie, Berlin

33401

Florida Cancer Specialists, West Palm Beach

33705

Florida Cancer Specialist, North Region, St. Petersburg

33908

Florida Cancer Specialists-Broadway, Fort Myers, Fort Myers

37203

Sarah Cannon Research Institute, Nashville

45242

Oncology Hematology Care Inc, Cincinnati

50135

Az. Osp. Di Careggi; Divisione Di Ematologia, Florence

52074

Uniklinik RWTH Aachen; Med. Klinik IV; Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammz, Aachen

77030

Uni of Texas - Md Anderson Cancer Center; Dept of Leukemia, Houston

T2N 4N2

Tom Baker Cancer Centre-Calgary; Clinical Research Unit, Calgary

B3H 2Y9

Queen Elizabeth II Health Sciences Centre; Oncology, Halifax

H2L 4M1

Centre Hospitalier De L'Universite De Montreal, Hopital Notre-Dame, Montreal

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02593760 - A Study to Evaluate the Efficacy and Safety of Vismodegib in Combination With Ruxolitinib for the Treatment of Intermediate- or High-Risk Myelofibrosis (MF) | Biotech Hunter | Biotech Hunter