MedTrace Logo

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

NCT02885766 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2020-02-17

No results posted yet for this study

Summary

A multicenter, open label cohort Phase 1 dose finding study to evaluate tolerability, safety, pharmacokinetics and preliminary efficacy of PF-114 for oral administration in adult patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML), which is resistant to the 2-nd generation Bcr-Abl inhibitors or has T315I mutation in the BCR-ABL gene.

Conditions

  • Chronic Myeloid Leukemia
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

DRUG

PF-114

Sponsors & Collaborators

  • OCT LLC

    collaborator INDUSTRY

  • Data Matrix Solutions

    collaborator OTHER

  • Skolkovo Innovation Center

    collaborator UNKNOWN

  • Fusion Pharma LLC

    lead INDUSTRY

Principal Investigators

  • Anna Turkina, Professor · Federal Haematological Scientific Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-06-30
Completion
2020-05-31

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02885766 on ClinicalTrials.gov