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
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small Cell Lung
Drug: talabostat mesylate
Drug: docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Point Therapeutics:

Estimated Enrollment: 400
Study Start Date: January 2006
  Eligibility

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

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.
  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: NCT00243204

  Show 96 Study Locations
Sponsors and Collaborators
Point Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00243204     History of Changes
Other Study ID Numbers: PTH-304
Study First Received: October 19, 2005
Last Updated: June 7, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Point Therapeutics:
Stage IIIb/IV non-small cell lung cancer
NSCLC
Lung Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014