NCT01776723 - A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 20, 2013

Primary Completion Date

November 28, 2018

Study Completion Date

May 10, 2022

Conditions

Myelomonocytic Leukemia

Interventions

DRUG

Ruxolitinib

In Phase I, participants will be allocated to twice a day (BID) doses of 10 mg/d up to 40mg/d. The starting dose will be 10 mg/d (5mg BID). Each cohort will include up to 6 subjects. Once MTD is reached, 10 additional participants will be treated during the first stage of Phase II (stage 1) at the MTD.

Trial Locations (6)

10021

Weill Medical College of Cornell, New York

21287

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

44106

Cleveland Clinic, Cleveland

02115

Brigham and Women's Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston