Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Non Small Cell Lung Cancer

In brief

The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens.

Key facts

Study ID

NCT00707304

Run by

Agennix

People needed

742

Starts

2008-11-01

Expected to finish

2012-08-01

Last updated by the study team

2012-08-21

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed stage IIIB or IV NSCLC
• Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC
• At least one target lesion that is unirradiated and measurable by RECIST
• Adequate hematologic, renal and hepatic function
• ECOG 0, 1, or 2
• Able to understand and sign an Informed Consent

You may not qualify if…

• Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
• Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
• History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years
• Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
• Serious active infection
• Psychiatric illness/ social situations that would limit study compliance
• Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
• Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
• Known HIV positive or on active anti-retroviral therapy
• Known Hepatitis B surface antigen positive or hepatitis C positive
• Receipt of any investigational medication within 4 weeks prior to randomization
• Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
• Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
• Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian

Where it is running

• Arizona Oncology Associates — Tucson, Arizona, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Pasco Pinellas Cancer Center — New Port Richey, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Cancer Care Specialists of Central Illinois — Decatur, Illinois, United States
• Cancer Care & Hematology Specialists of Chicagoland — Niles, Illinois, United States
• Central Indiana Cancer Centers — Greenfield, Indiana, United States
• Kansas City Cancer Center, LLC — Overland Park, Kansas, United States
• NCI, CCR, The Waren Grant Magnuson Clinical Center — Bethesda, Maryland, United States
• Newland Medical Associates — Southfield, Michigan, United States
• Minnesota Oncology and Hematology, PA — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Southeast Nebraska Cancer Center — Lincoln, Nebraska, United States
• NH Oncology-Hematology, PA — Hooksett, New Hampshire, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Alamance Regional Medical Center — Burlington, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Rex Cancer Center — Raleigh, North Carolina, United States
• Legacy Pharma Research — Bismarck, North Dakota, United States
• Signal Point Clinical Research Center — Middletown, Ohio, United States
• Kaiser Group Health — Portland, Oregon, United States
• Texas Oncology — Dallas, Texas, United States
• Desert Oasis Cancer Center — Casa Grande, Arizona, United States

Full record on ClinicalTrials.gov

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