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Status:

TERMINATED

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

Lead Sponsor:

Point Therapeutics

Conditions:

Carcinoma, Non-Small Cell Lung

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    400 Patients enrolled

    Trial Details

    Trial ID

    NCT00243204

    Start Date

    January 1 2006

    Last Update

    June 8 2007

    Active Locations (96)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 24 (96 locations)

    1

    Marshall Schreeder, MD

    Huntsville, Alabama, United States, 35801

    2

    James P. Daugherty, MD

    Muscle Shoals, Alabama, United States, 35661

    3

    Alaska Cancer Research

    Anchorage, Alaska, United States, 99508

    4

    Hematology Oncology Associates

    Phoenix, Arizona, United States, 85012