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

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 1

Conditions

Philadelphia Chromosome Positive (Ph+) Acute Lymphocytic Leukemia (ALL)

Blast Phase Philadelphia Chromosomes Positive (Ph+) Chronic Myelogenous Leukemia (CML)

Treatments

Other: Comparator: Biomarker evaluation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00860535

0000-098

2009_558

Details and patient eligibility

About

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

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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