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Sponsored by: |
Agennix |
Information provided by: | Agennix |
ClinicalTrials.gov Identifier: | NCT00707304 |
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.
Condition | Intervention | Phase |
Non Small Cell Lung Cancer |
Drug: Talactoferrin Drug: Placebo |
Phase III |
MedlinePlus related topics: | Cancer Lung Cancer |
Drug Information available for: | Talactoferrin Alfa Lactoferrin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | FORTIS-M: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-Small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens |
Estimated Enrollment: | 720 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Talactoferrin
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Drug: Talactoferrin
Oral, 1.5 grams twice per day
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2: Placebo Comparator
Placebo
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Drug: Placebo
Oral, twice per day
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yenyun Wang, MD | 713-552-1091 | ywang@agennix.com |
Contact: Rajesh Malik, MD | 713-552-1091 | rmalik@agennix.com |
Agennix |
Responsible Party: | Agennix Incorporated ( Rajesh Malik, MD Chief Medical Officer ) |
Study ID Numbers: | LF-0207 |
First Received: | June 26, 2008 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00707304 |
Health Authority: | United States: Food and Drug Administration |
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