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Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

This study has been terminated.
(FDA Hold May 2007)
Sponsor:
Information provided by:
Point Therapeutics
ClinicalTrials.gov Identifier:
NCT00243204
First received: October 19, 2005
Last updated: June 7, 2007
Last verified: June 2007

October 19, 2005
June 7, 2007
January 2006
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Complete list of historical versions of study NCT00243204 on ClinicalTrials.gov Archive Site
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Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy
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This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.

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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Carcinoma, Non-Small Cell Lung
  • Drug: talabostat mesylate
  • Drug: docetaxel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
400
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INCLUSION CRITERIA:

  • Men or women age 18 years or older
  • Histologically or cytologically confirmed NSCLC

    • Recurrent, locally advanced or metastatic, inoperable NSCLC (Stage IIIB/IV)
    • Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion
  • Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
  • Measurable disease on computerized tomography (CT) scan
  • ECOG Performance Status of 0 or 1
  • Expected survival ≥12 weeks
  • Provide written informed consent

EXCLUSION CRITERIA:

  • More than 2 prior chemotherapy regimens
  • Clinically significant laboratory abnormalities, specifically:

    • Total bilirubin ≥ institutional upper limit of normal (ULN)
    • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN
    • Serum creatinine ≥2.0mg/dL
    • Absolute neutrophil count <1500/μL or platelets <100,000/μL
  • Untreated or symptomatic brain metastases
  • Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
  • A history of severe hypersensitivity to drugs formulated with polysorbate 80
  • Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
  • Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC.
  • Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00243204
PTH-304
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Point Therapeutics
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Point Therapeutics
June 2007

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