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Growth Factor Signature (GFS) Pilot Study (MK0000-098)(COMPLETED)

NCT00860535 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2015-09-30

Study results available
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Summary

This study will evaluate a gene expression signature (Growth Factor Signature \[GFS\]) as a biomarker for response/resistance to BRC-ABL oncogene inhibitors.

Conditions

  • Blast Phase Philadelphia Chromosomes Positive (Ph+) Chronic Myelogenous Leukemia (CML)
  • Philadelphia Chromosome Positive (Ph+) Acute Lymphocytic Leukemia (ALL)

Interventions

OTHER

Comparator: Biomarker evaluation

Patients on standard of care treatment will have blood drawn to evaluate biomarker changes in response to treatment with BCR-ABL inhibitors over a \~3.5 month period. Part I will enroll patients who are beginning treatment with imatinib (recommended dose 400 mg every day \[qd\]), dasatinib (recommended dose 70 mg twice a day \[bid\]), or nilotinib (recommended dose 400 mg bid). Part II will enroll patients who are changing from imatinib therapy to either dasatinib or nilotinib. A decision to initiate Part II will be made based on analysis of the results of Part I.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-04-30
Completion
2010-06-30

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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 NCT00860535 on ClinicalTrials.gov