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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

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.
 
ClinicalTrials.gov Identifier: NCT00243204
Recruitment Status : Terminated (FDA Hold May 2007)
First Posted : October 21, 2005
Last Update Posted : June 8, 2007
Sponsor:
Information provided by:
Point Therapeutics

Tracking Information
First Submitted Date  ICMJE October 19, 2005
First Posted Date  ICMJE October 21, 2005
Last Update Posted Date June 8, 2007
Study Start Date  ICMJE January 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small Cell Lung
Intervention  ICMJE
  • Drug: talabostat mesylate
  • Drug: docetaxel
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: October¬†19,¬†2005)
400
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00243204
Other Study ID Numbers  ICMJE PTH-304
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Point Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Point Therapeutics
Verification Date June 2007

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