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

Stopped early · Phase 3

Conditions studied: Carcinoma, Non-Small-Cell Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary

In brief

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.

Key facts

Study ID

NCT00290017

Run by

Point Therapeutics

People needed

400

Starts

2006-02-01

Last updated by the study team

2007-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hematology Oncology Associates — Phoenix, Arizona, United States
• Heritage Physician Group-Oncology — Hot Springs, Arkansas, United States
• Raul R. Mena, MD — Burbank, California, United States
• Pacific Coast Hematology / Oncology Medical Group, Inc. — Fountain Valley, California, United States
• Robert A. Moss, MD, FACP, Inc. — Fountain Valley, California, United States
• Antelope Valley Cancer Center — Lancaster, California, United States
• Warren Paroly, MD — Oceanside, California, United States
• Southwest Cancer Care Medical Group — Poway, California, United States
• Mile High Oncology — Denver, Colorado, United States
• Medical Specialists of Fairfield — Fairfield, Connecticut, United States
• Northwestern Connecticut Oncology Hematology Associates, LLP — Torrington, Connecticut, United States
• Lucio Gordan, MD — Gainesville, Florida, United States
• Cancer and Blood Disease Center — Lecanto, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Cancer Center of Florida — Ocoee, Florida, United States
• Northeast Georgia Cancer Care, LLC — Athens, Georgia, United States
• North Idaho Cancer Center — Coeur d'Alene, Idaho, United States
• Hematology Oncology Associates of Illinois — Chicago, Illinois, United States
• Joliet Oncology-Hematology Associates — Joliet, Illinois, United States
• American Health Network of Indiana--Hematology/Oncology — Indianapolis, Indiana, United States
• Arnett Cancer Center — Lafayette, Indiana, United States
• Northern Indiana Oncology Associates — South Bend, Indiana, United States
• Associated Physicians and Surgeons, LLC — Terre Haute, Indiana, United States
• HUX Cancer Center/Union Hospital — Terre Haute, Indiana, United States
• Marshall Schreeder, MD — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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