Clinical trial · Interventional
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
NCT00335868CI-TRIAL-00013061unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| danusertib | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Antileukemic response in terms of complete hematological response, no evidence of leukemia, or return to chronic phase
- measure
- Overall safety profile of PHA-739358 by type, severity, timing, and relatedness of adverse events and laboratory abnormalities
- measure
- Pharmacokinetics of this drug and its N-oxide metabolite PHA-816359 by measuring their plasma concentration at different times after dosing
- measure
- Changes in histone H3 and CRKL phosphorylation
- measure
- Correlation between changes in degree of histone H3 and CRKL phosphorylation and concurrent PHA-739358 concentrations and/or hematological response
- measure
- Complete, partial, or minor cytogenetic response in bone marrow
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of chronic myelogenous leukemia confirmed by bone marrow biopsy * Chronic, accelerated, or blastic phase disease * May have T315I mutation in BCR-ABL kinase * Relapsed after prior imatinib mesylate or c-ABL therapy * No CNS leukemia PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Blood pressure ≤ 140/90 mm Hg (with or without hypertension treatment for ≥ 1 week) * Transaminases ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Creatinine ≤ 1.5 times ULN * No known history of HIV infection * No active uncontrolled infection * No grade 3 or 4 bleeding * LVEF ≥ 45% by MUGA or ≥ 40% by transthoracic echocardiography * No medical or psychiatric condition or laboratory abnormalities that would limit study compliance or increase risk during study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 90 (female) or 180 (male) days after completion of study treatment * No significant cardiovascular disease (i.e., uncontrolled arrhythmias or unstable angina) within the past 6 months * No major thromboembolic event within the past 6 months, including any of the following: * Myocardial infarction * Stroke * Transient ischemic attack * Pulmonary embolism * Noncatheter-related deep-vein thrombosis PRIOR CONCURRENT THERAPY: * Recovered from all acute toxic effects (excluding alopecia) of prior therapy * More than 2 weeks since prior chemoimmunotherapy * Hydroxyurea must be discontinued 1 day prior to study therapy * More than 4 weeks since prior major surgery * No other concurrent approved or investigational anticancer treatment, including chemotherapy, biologic response modifiers, hormones, or immunotherapy * No other concurrent investigational drugs * No concurrent participation in another treatment clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.