Status:
TERMINATED
Study of Talabostat and Pemetrexed vs. Pemetrexed 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
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This Phase 3 study will compare the efficacy of talabostat plus pemetrexed to pemetrexed plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.
Eligibility Criteria
Inclusion
- Men or women age ≥18 years
- 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
- More than 2 prior chemotherapy regimens
- Progression of disease on prior pemetrexed treatment
- Brain metastases (exception: patients who had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month)
- Serum creatinine ≥2.0mg/dL or creatinine clearance \<45mL/min
- Absolute neutrophil count \<1500/μL or platelets \<100,000/μL
- Any malignancy within 5 years immediately prior to the first dose of study medication (exception: basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix)
- 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 investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment.
- Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception during treatment.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00290017
Start Date
February 1 2006
Last Update
June 8 2007
Active Locations (101)
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1
Marshall Schreeder, MD
Huntsville, Alabama, United States, 35801
2
Hematology Oncology Associates
Phoenix, Arizona, United States, 85012
3
Heritage Physician Group-Oncology
Hot Springs, Arkansas, United States, 71913
4
Raul R. Mena, MD
Burbank, California, United States, 91505-4866