None listed
Conditions
Interventions
Group 1 Type of group
Talactoferrin alfa (talactoferrin or TLF, also known as recombinant human lactoferrin, rhLF or talactoferrinum alfa) is a recombinant version of the glycoprotein expressed in and purified from Aspergillus niger var. awamori. Talactoferrin is structurally and functionally similar to native human lactoferrin. The structural equivalence of talactoferrin to native human lactoferrin has been demonstrated by a comparison of the 3-dimensional structure, molecular weight, biological activity and other p
Placebo contains the same phosphate-based buffer used as the diluent for the talactoferrin solution. In addition, the placebo will contain FD&C/EU grade dyes suitable for oral use to mimic the color of the vialed drug product.
Sponsors
Agennix Incorporated,
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • 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 criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The OS will be defined as the time from the date of random assignment until the date of death. Measure:Overall survival Timepoints:After the occurence of the required number of events | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The SSP will be defined as the time from the date of random assignment to the date of the objective progression of the tumor or death. Measure:Progression free survival Timepoints:At time of final analysis ; Outcome name:The best overall response is the best response recorded from the first dose of the study drug to the progression or recurrence of the disease (taking as a reference for progressive disease the smallest measures recorded since the first dose of the study drug). The assignment of the best patient response will depend on whether both the measure and the confirmation criteria are achieved. Measure:Objective response and disease stablization rate Timepoints:At time of final analysis ; Outcome name:Record of adverse events occurred during the study. Measure:Safety and tolerability Timepoints:At time of final analysis | — |
Countries
Australia, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hungaria, India, Italy, Korea South, Latovia, Malasya, Philippines, Poland, Romania, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kindgdom, United States
Contacts
Public ContactGabriela Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed