A Study to Evaluate PT-523 in Patients With Refractory Leukemia
Phase 1
Withdrawn
- Conditions
- Leukemia
- Registration Number
- NCT00129558
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Brief Summary
This Phase I/II, multi-centered, non-randomized, trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with refractory leukemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Relapsed/refractory leukemias including acute non-lymphocytic leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), and chronic myelogenous leukemia in blastic phase (CML-BP) for which no standard therapies are anticipated to result in a durable remission; or poor-risk myelodysplasia (MDS) patients to include refractory anemia with excess blasts (RAEB) or excess blasts in transformation (RAEBT) and chronic myelomonocytic leukemia (CMML) who are either relapsed/refractory or who refuse/are not eligible for frontline therapy.
- Only patients with refractory ALL or CML in lymphoid blastic phase are eligible for phase II.
- ECOG performance status 0 - 2.
- Adequate organ function and bone marrow reserve.
- At least 4 weeks must have elapsed from the time of major surgery.
- Use of appropriate contraceptive method.
- Signed patient informed consent.
Exclusion Criteria
- Known human immunodeficiency virus (HIV).
- Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
- Patients receiving any other standard or investigational treatment for their leukemia other than corticosteriods, hydroxyurea, and 6-mercaptopurine.
- Any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
USC, Kennth Norris Jr. Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Texas M. D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Wake Forest University School of Medicine Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States