NCT00335868

PHA-739358 in Treating Patients With Chronic Myelogenous Leukemia That Relapsed After Imatinib Mesylate or c-ABL Therapy

A Pilot Phase II Study of PHA-739358 in Patients With Chronic Myeloid Leukemia Relapsing on Gleevec or c-ABL Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	danusertib
OTHER	laboratory biomarker analysis
OTHER	pharmacological study

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-12-01
• First posted: 2006-06-12
• Last updated: 2013-12-18

Locations

1 site across 1 country: United States