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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00112060
First received: May 27, 2005
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Non-Small-Cell Lung Carcinoma
Drug: PT-523 for Injection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Enrollment: 0
Study Start Date: April 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112060

Locations
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 Clinical Pharmacology and Chemotherapy
Moscow, Russian Federation, 115478
Semashko Central Clinical Hospital
Moscow, Russian Federation, 129128
Blokhin Cancer Research Center Department of Chemotherapy and Combination Treatment of Neoplasia
Moscow, Russian Federation, 115478
St. Petersburg Oncology Center Thoracic Department
St. Petersburg, Russian Federation, 198255
St. Petersburg Pavlov State Medical University
St. Petersburg, Russian Federation, 197022
Petrov Research Institute of Oncology
St. Petersburg, Russian Federation, 197758
Yaroslavl City Oncology Center
Yaroslavl, Russian Federation, 150054
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00112060     History of Changes
Other Study ID Numbers: HBS101, HBS101.00
Study First Received: May 27, 2005
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Spectrum Pharmaceuticals, Inc:
Talotrexin
PT-523
Non-Small Cell Lung Carcinoma (NSCLC)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 19, 2014