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Sponsored by: |
Agennix |
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Information provided by: | Agennix |
ClinicalTrials.gov Identifier: | NCT00706862 |
The purpose of the study is to determine whether the combination of talactoferrin, carboplatin and paclitaxel improves progression free survival and overall survival in patients with non-small cell lung cancer compared to the combination of paclitaxel and carboplatin alone
Condition | Intervention | Phase |
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Non Small Cell Lung Cancer |
Drug: Talactoferrin Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | FORTIS-C: A Phase 3, Randomized, Placebo-Controlled Study of Oral Talactoferrin in Combination With Carboplatin and Paclitaxel as First-Line Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer |
Estimated Enrollment: | 1100 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Talactoferrin, Carboplatin, Paclitaxel
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Drug: Talactoferrin
Oral, 1.5 grams twice per day
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2: Placebo Comparator
Placebo, Carboplatin, Paclitaxel
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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 |
Responsible Party: | Agennix Incorporated ( Rajesh Malik, MD Chief Medical Officer ) |
Study ID Numbers: | LF-0208 |
Study First Received: | June 26, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00706862 |
Health Authority: | United States: Food and Drug Administration |
Non small cell lung cancer Talactoferrin Dendritic cell recruiter and activator |
DCRA Immunomodulatory agent Lactoferrin |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms |
Lung Diseases Carboplatin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |