Status:
WITHDRAWN
A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Histologically or cytologically confirmed NSCLC which is stage III or stage IV, or recurrent disease, and failed therapy with a standard first line (Phase I/II) as well as second line chemotherapy regimen (Phase I), or be intolerant of standard chemotherapy. Receipt of one additional prior chemotherapy regimen for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant is allowable. A prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TK) antagonist is allowable (Phase II).
- Asymptomatic or treated brain metastases (including steroids) if last therapy was received \> 4 weeks from study entry and is deemed by the investigator to have a low likelihood of rapid deterioration.
- ECOG performance status 0 - 2.
- Adequate organ function and bone marrow reserve.
- Use of appropriate contraceptive method.
- Signed patient informed consent.
Exclusion
- Investigational agents within 30 days prior to Day 1 of study.
- Known symptomatic or uncontrolled brain metastases.
- Uncontrolled intercurrent illness.
- Known human immunodeficiency virus (HIV), hepatitis A, B, C, D and E.
- Patient has uncontrolled pleural effusions.
- Patient has received nitrosoureas or mitomycin-C within 6 weeks or other chemotherapy or radiation therapy within 3 weeks before study entry.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00112060
Start Date
April 1 2008
End Date
September 1 2011
Last Update
March 31 2014
Active Locations (13)
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1
University of Miami and Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
2
University of Chicago
Chicago, Illinois, United States, 60637-1470
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
Case Western Reserve University & University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106