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

Phase 1

Withdrawn

• Conditions: Non-Small-Cell Lung Carcinoma

• Registration Number: NCT00112060
• 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 NSCLC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-05-27
• Study First Submitted QC: 2005-05-27
• Study First Posted: 2005-05-30
• Study Start: 2008-04
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-27
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (13)

Irkutsk Regional Oncology Center; 🇷🇺 Irkutsk, Russian Federation

Petrov Research Institute of Oncology; 🇷🇺 St. Petersburg, Russian Federation

University of Miami and Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

St. Petersburg Oncology Center Thoracic Department; 🇷🇺 St. Petersburg, Russian Federation

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Case Western Reserve University & University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States

Blokhin Cancer Research Center Department of Chemotherapy and Combination Treatment of Neoplasia; 🇷🇺 Moscow, Russian Federation

Semashko Central Clinical Hospital; 🇷🇺 Moscow, Russian Federation

St. Petersburg Pavlov State Medical University; 🇷🇺 St. Petersburg, Russian Federation

Blokhin Cancer Research Center Department of Clinical Pharmacology and Chemotherapy; 🇷🇺 Moscow, Russian Federation

Yaroslavl City Oncology Center; 🇷🇺 Yaroslavl, Russian Federation

Chelyabinsk Regional Oncology Center Chemotherapy Department; 🇷🇺 Chelyabinsk, Russian Federation