Study of Talabostat + Docetaxel Versus Docetaxel 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

In brief

This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.

Key facts

Study ID

NCT00243204

Run by

Point Therapeutics

People needed

400

Starts

2006-01-01

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 or older
• 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
• Clinically significant laboratory abnormalities, specifically:
• Total bilirubin ≥ institutional upper limit of normal (ULN)
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN
• Serum creatinine ≥2.0mg/dL
• Absolute neutrophil count <1500/μL or platelets <100,000/μL
• Untreated or symptomatic brain metastases
• Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
• A history of severe hypersensitivity to drugs formulated with polysorbate 80
• 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 other investigational medication for NSCLC.
• Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.

Where it is running

• James P. Daugherty, MD — Muscle Shoals, Alabama, United States
• Alaska Cancer Research — Anchorage, Alaska, United States
• Hematology Oncology Associates — Phoenix, Arizona, United States
• Veena Charu, MD — Anaheim, California, United States
• Lalita Pandit, MD, Inc — Fountain Valley, California, United States
• Robert A. Moss, MD, FACP, Inc. — Fountain Valley, California, United States
• Warren Paroly, MD — Oceanside, California, United States
• Swarna S. Chanduri, MD — Pomona, California, United States
• Southwest Cancer Care Medical Group — Poway, California, United States
• Mile High Oncology — Denver, Colorado, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Medical Specialists of Fairfield — Fairfield, Connecticut, United States
• Pasco Hernando Oncology Associates PA — Brooksville, Florida, United States
• Lucio Gordan, MD — Gainesville, Florida, United States
• Citrus Hematology and Oncology Center — Inverness, Florida, United States
• Nature Coast Clinical Research, LLC — Inverness, Florida, United States
• Jorge G. Otoya, MD — Kissimmee, Florida, United States
• Cancer and Blood Disease Center — Lecanto, Florida, United States
• Pasco Hernando Oncology Associates, PA — New Port Richey, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Cancer Center of Florida — Ocoee, Florida, United States
• Hematology Oncology Associates of Illinois — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Joliet Oncology Hematology Associates — Joliet, Illinois, United States
• Marshall Schreeder, MD — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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