Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Point Therapeutics
• Treatments: Pemetrexed

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.