Health Condition 1: null- Non Small Cell Lung Cancer
Conditions
Interventions
Intervention1: Talactoferrin: oral, 1.5 gm twice per day
Control Intervention1: Placebo: oral, twice per day
Sponsors
Agennix Incorporated
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survivalTimepoint: After the occurrence of the required number of events | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Germany, Greece, India, Italy, Latvia, Lithuania, Malaysia, Mexico, Peru, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactSuchela Srivatsa
Quintiles Research (India) Pvt Ltd.
Outcome results
None listed