A Phase 3 interventional study of Talactoferrin and Placebo in Non Small Cell Lung Cancer, sponsored by Agennix. Completed at 189 sites in 23 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-21.
Sponsored by Agennix · Phase 3, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 742 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Agennix is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 physicochemical properties, and is known to differ only in the nature of glycosylation.
Drug: Talactoferrin
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.
Drug: Placebo
Oral, 1.5 grams twice per day
Also known as: talactoferrin alfa, TLF, recombinant human lactoferrin, rhLF
Oral, twice per day
Overall survival
Time frame: After the occurence of the required number of events
Progression free survival
Time frame: At time of final analysis
Objective response and disease stablization rate
Time frame: At time of final analysis
Safety and tolerability
Time frame: At time of final analysis
Showing the first 100 of 189 sites across 23 countries.
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Agennix