Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer
- Conditions
- Health Condition 1: null- Non Small Cell Lung Cancer
- Registration Number
- CTRI/2010/091/000034
- Lead Sponsor
- Agennix Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 720
1. Age greater than and equal to 18 yrs
2. Histologically or cytologically confirmed stage IIIB or IV NSCLC
3. Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC
4. At least one target lesion that is unirradiated and measurable by RECIST
5. Adequate hematologic, renal and hepatic function
6. ECOG 0, 1, or 2
7. Able to understand and sign an Informed Consent
1. 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
2. Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
3. 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
4. Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
5. Serious active infection
6. Psychiatric illness/ social situations that would limit study compliance
7. Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
8. 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)
9. Known HIV positive or on active anti-retroviral therapy
10. Known Hepatitis B surface antigen positive or hepatitis C positive
11. Receipt of any investigational medication within 4 weeks prior to randomization
12. 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
13. Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
14. Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survivalTimepoint: After the occurrence of the required number of events
- Secondary Outcome Measures
Name Time Method Objective response and disease stabilization rateTimepoint: At time of final analysis;Progression free survivalTimepoint: At time of final analysis;Safety and tolerabilityTimepoint: At time of final analysis;Survival RateTimepoint: Six month and one year