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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)

This study has been withdrawn prior to enrollment.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

May 27, 2005
March 27, 2014
April 2008
September 2011   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00112060 on ClinicalTrials.gov Archive Site
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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)
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)

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small-Cell Lung Carcinoma
Drug: PT-523 for Injection
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation
 
NCT00112060
HBS101, HBS101.00
Not Provided
Spectrum Pharmaceuticals, Inc
Spectrum Pharmaceuticals, Inc
Not Provided
Not Provided
Spectrum Pharmaceuticals, Inc
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP