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

Point Therapeutics

Status and phase

Terminated

Phase 3

Conditions

Neoplasms, Pulmonary

Neoplasms, Lung

Carcinoma, Non-Small-Cell Lung

Lung Cancer

Treatments

Drug: talabostat

Drug: pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT00290017

PTH-305

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.