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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00112060
Recruitment Status : Withdrawn
First Posted : May 30, 2005
Last Update Posted : March 31, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Drug: PT-523 for Injection Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label, Multicenter Study of Single Agent PT-523 in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : April 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00112060

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United States, Florida
University of Miami and Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637-1470
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Case Western Reserve University & University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Russian Federation
Chelyabinsk Regional Oncology Center Chemotherapy Department
Chelyabinsk, Russian Federation, 454087
Irkutsk Regional Oncology Center
Irkutsk, Russian Federation, 664035
Blokhin Cancer Research Center Department of Chemotherapy and Combination Treatment of Neoplasia
Moscow, Russian Federation, 115478
Blokhin Cancer Research Center Department of Clinical Pharmacology and Chemotherapy
Moscow, Russian Federation, 115478
Semashko Central Clinical Hospital
Moscow, Russian Federation, 129128
St. Petersburg Pavlov State Medical University
St. Petersburg, Russian Federation, 197022
Petrov Research Institute of Oncology
St. Petersburg, Russian Federation, 197758
St. Petersburg Oncology Center Thoracic Department
St. Petersburg, Russian Federation, 198255
Yaroslavl City Oncology Center
Yaroslavl, Russian Federation, 150054
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc

Additional Information:
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Responsible Party: Spectrum Pharmaceuticals, Inc Identifier: NCT00112060    
Other Study ID Numbers: HBS101
First Posted: May 30, 2005    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014
Keywords provided by Spectrum Pharmaceuticals, Inc:
Non-Small Cell Lung Carcinoma (NSCLC)
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases