A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Non-Small-Cell Lung Carcinoma

In brief

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 NSCLC.

Key facts

Study ID

NCT00112060

Run by

Spectrum Pharmaceuticals, Inc

People needed

0

Starts

2008-04-01

Expected to finish

2011-09-01

Last updated by the study team

2014-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Miami and Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Case Western Reserve University & University Hospitals of Cleveland — Cleveland, Ohio, United States
• Chelyabinsk Regional Oncology Center Chemotherapy Department — Chelyabinsk, Russia
• Irkutsk Regional Oncology Center — Irkutsk, Russia
• Blokhin Cancer Research Center Department of Chemotherapy and Combination Treatment of Neoplasia — Moscow, Russia
• Blokhin Cancer Research Center Department of Clinical Pharmacology and Chemotherapy — Moscow, Russia
• Semashko Central Clinical Hospital — Moscow, Russia
• St. Petersburg Pavlov State Medical University — Saint Petersburg, Russia
• Petrov Research Institute of Oncology — Saint Petersburg, Russia
• St. Petersburg Oncology Center Thoracic Department — Saint Petersburg, Russia
• Yaroslavl City Oncology Center — Yaroslavl, Russia

Full record on ClinicalTrials.gov

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