Status:
COMPLETED
Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer
Lead Sponsor:
Agennix
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 regim...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
742 Patients enrolled
Trial Details
Trial ID
NCT00707304
Start Date
November 1 2008
End Date
August 1 2012
Last Update
August 21 2012
Active Locations (189)
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1
Desert Oasis Cancer Center
Casa Grande, Arizona, United States, 85122
2
Arizona Oncology Associates
Tucson, Arizona, United States, 85710
3
University of Colorado Hospital
Aurora, Colorado, United States, 80045
4
Pasco Pinellas Cancer Center
New Port Richey, Florida, United States, 34652