Clinical trial NCT00860535: Growth Factor Signature (GFS) Pilot Study (MK0000-098)(COMPLETED)
Official title: A Multicenter Phase Ib Trial to Determine Whether a Gene Expression Signature Changes in Response to Treatment With Bcr-Abl Inhibitors in Patients With Blast Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Blast Phase Philadelphia Chromosomes Positive (Ph+) Chronic Myelogenous Leukemia (CML)
Philadelphia Chromosome Positive (Ph+) Acute Lymphocytic Leukemia (ALL)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-03-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: Inclusion Criteria:

* Participant must have a histologically or cytopathologically confirmed blast phase Ph+ CML or Ph+ ALL.
* Participant is 18 years of age on the day of signing informed consent
* Participant must have performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Participant has at least 30 percent blasts in peripheral blood; or at least 30 percent lymphoblasts in peripheral blood or bone marrow

  * For Part II:
* Participant has progressed while taking imatinib or is unable to tolerate imatinib, being defined as discontinuing imatinib treatment as a result of nonhematologic toxic effects of any grade
* If female, participant is either post-menopausal, free from menses for \>2 years, surgically sterilized or willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from heterosexual activity throughout the study, starting with Visit 1
* Female participants of childbearing potential must have a negative serum or urine pregnancy test (beta hCG) at screening
* If male, participant is surgically sterilized, agrees to use an adequate method of contraception, or agrees to abstain from heterosexual activity for the duration of the study
* Participant or the patrticipant's legal representative has voluntarily agreed to participate by giving written informed consent
* Participant must be available for periodic blood sampling, study related assessments, and management at the treating institution for the duration of the study

Exclusion Criteria:

* Participant is currently participating in or has participated in a study with an investigational compound or device within 30 days or 5 half-lives, whichever is longer, of the start of treatment
* Participant has known human immunodeficiency virus (HIV) infection or HIV-related malignancy
* Participant is a female who is pregnant or breastfeeding, or is expecting to conceive within the projected duration of the study
* Participant has a known allergy or hypersensitivity to imatinib, dasatinib or nilotinib
* Participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate
* Participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* There is any concern by the investigator regarding the safe participation of the participant in the study or for any other reason, the investigator considers the participant inappropriate for participation in the study

Primary outcomes:
measure: Growth Factor Signature (GFS) Variability at Baseline
timeFrame: Screening to Day 1 Predose
measure: Growth Factor Signature (GFS) Change From Baseline Measured by Time Weighted Average (TWA) for Days 1 to 22
timeFrame: Baseline to 22 Days After Initiation of Therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: