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

Phase 3

Terminated

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

• Registration Number: NCT00290017
• Lead Sponsor: Point Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-10
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-07
• Last Update Posted: 2007-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (95)

Marshall Schreeder, MD; 🇺🇸 Huntsville, Alabama, United States

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

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