A Study to Evaluate PT-523 in Patients With Refractory Leukemia

Leukemia Clinical Trial

Official title:

A Phase I/II Study of PT-523 in Patients With Refractory Leukemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00129558
• Other study ID #: HBS103
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: August 10, 2005
• Last updated: December 2, 2013
• Start date: July 2005
• Est. completion date: September 2011

Study information

• Verified date: December 2013
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia

Intervention

Drug:
• PT-523 for Injection

Locations

Country	Name	City	State
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	UCLA School of Medicine	Los Angeles	California
United States	USC, Kennth Norris Jr. Comprehensive Cancer Center	Los Angeles	California
United States	Wake Forest University School of Medicine Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc

Country where clinical trial is conducted

United States,