Leukemia Clinical Trial
Official title:
A Pilot Phase II Study of PHA-739358 in Patients With Chronic Myeloid Leukemia Relapsing on Gleevec or c-ABL Therapy
RATIONALE: PHA-739358 may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase II trial is studying how well PHA-739358 works in treating patients with
chronic myelogenous leukemia that relapsed after imatinib mesylate or c-ABL therapy.
OBJECTIVES:
- Explore the clinical efficacy of PHA-739358, in terms of hematological response lasting
≥ 4 weeks, in patients with chronic myelogenous leukemia that relapsed after imatinib
mesylate or c-ABL therapy.
- Explore the safety profile of this drug in these patients.
- Explore the pharmacokinetic profile of this drug and its N-oxide metabolite PHA-816359
in plasma.
- Explore the modulation of histone H3 and CRKL phosphorylation after PHA-739358
administration.
- Explore the relationship between plasma drug levels and the modulation of histone H3
and CRKL phosphorylation.
- Explore the clinical efficacy of this drug, in terms of cytogenetic response in bone
marrow.
- Explore response depending on status of T315I mutation in BCR-ABL kinase.
OUTLINE: This is a pilot, open-label, multicenter study.
Patients receive PHA-739358 IV over 6 hours on days 1, 8, and 15. Treatment repeats every 28
days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients
benefitting from treatment may receive additional courses at the discretion of the
investigator.
Patients undergo blood collection and bone marrow biopsies periodically for pharmacologic
and biomarker correlative studies.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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