Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 for Oral Administration in Adults With Ph+ Chronic Myeloid Leukemia, Which is Resistant to the 2-nd Generation Bcr-Abl Inhibitors or Has T315I Mutation in the BCR-ABL Gene

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

June 30, 2018

Study Completion Date

May 31, 2020

Conditions
Chronic Myeloid LeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL Positive
Interventions
DRUG

PF-114

Trial Locations (3)

125167

Federal Haematological Scientific Center, Moscow

125284

Moscow City Centre of Hematology based on City Hospital named by S.Botkin, Moscow

Unknown

Federal Almazov North-West Medical Research Centre, Saint Petersburg

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

OCT LLC

INDUSTRY

collaborator

Data Matrix Solutions

OTHER

collaborator

Skolkovo Innovation Center

UNKNOWN

lead

Fusion Pharma LLC

INDUSTRY

NCT02885766 - Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 for Oral Administration in Adults With Ph+ Chronic Myeloid Leukemia, Which is Resistant to the 2-nd Generation Bcr-Abl Inhibitors or Has T315I Mutation in the BCR-ABL Gene | Biotech Hunter | Biotech Hunter