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OPTIM DASATINIB (Optimized Tyrosine Kinase Inhibitors Monotherapy)

NCT01916785 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2016-08-22

No results posted yet for this study

Summary

This protocol is a multicentric interventional phase II study from the French CML Intergroup (FILMC).

The core of the protocol is to explore the efficacy and safety of an optimization strategy consisting in the modulation of the dasatinib daily dose according to the results of repeated plasmatic levels of dasatinib.

The objective of this strategy is to improve the overall results of the treatment of early CP-CML in order to avoid the development of resistance and BCR-ABL tyrosine kinase mutations.

The study will be conducted in selected FILMC and Canadian centers.

The study is sponsored by the Hôpitaux de Versailles and supported by Bristol-Myers Squibb. The dasatinib treatment will be provided by Bristol-Myers Squibb until marketing authorization is granted in that indication.

Conditions

  • Chronic Myelogenous Leukemia, BCR/ABL Positive

Interventions

DRUG

Dasatinib

Dasatinib is a multitargeted tyrosine kinase inhibitor with a 300-fold more potent activity on the BCR-ABL tyrosine kinase in vitro compared to imatinib mesylate

Sponsors & Collaborators

  • Maisonneuve-Rosemont Hospital

    collaborator OTHER

  • University Hospital, Bordeaux

    collaborator OTHER

  • Versailles Hospital

    lead OTHER

Principal Investigators

  • Philippe ROUSSELOT, Professeur hémato-oncologie · Versailles Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Canada
  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT01916785 on ClinicalTrials.gov