Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-28 @ 4:18 AM
Study NCT ID:
NCT00335868
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2006-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PHA-739358 in Treating Patients With Chronic Myelogenous Leukemia That Relapsed After Imatinib Mesylate or c-ABL Therapy
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Pilot Phase II Study of PHA-739358 in Patients With Chronic Myeloid Leukemia Relapsing on Gleevec or c-ABL Therapy
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: