Safety and Efficacy of Talactoferrin in Addition to Standard Chemotherapy in Patients With Non-small Cell Lung Cancer (FORTIS-C)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Agennix
Sponsor:
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT00706862
First received: June 26, 2008
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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
Non Small Cell Lung Cancer
Drug: Talactoferrin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Agennix:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: After the occurence of the required number of events ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: At the time of final analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response and disease stabilization rate [ Time Frame: At the time of final analysis ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: At the time of final analysis ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: February 2009
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Talactoferrin, Carboplatin, Paclitaxel
Drug: Talactoferrin
Oral, 1.5 grams twice per day
Other Names:
  • talactoferrin alfa
  • TLF
  • recombinant human talactoferrin
  • rhLF
Placebo Comparator: 2
Placebo, Carboplatin, Paclitaxel
Drug: Placebo
Oral, twice per day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed locally advanced or metastatic non-small cell lung cancer that is unresectable
  • At least 1 unirradiated target lesion measurable by RECIST
  • Adequate hematologic, renal and hepatic function
  • ECOG 0,1
  • Able to understand and sign an Informed Consent

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
  • Received prior systemic anti-cancer therapy for NSCLC
  • History of allergic reactions to compounds of similar chemical or biologic composition to talactoferrin or the chemotherapy drugs
  • 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 render compliance or follow-up in the protocol problematic
  • Concurrent radiotherapy or radiotherapy within 4 weeks prior to randomization or previous radiotherapy at the indicator sites (the sites that are to be followed for determination of a response)
  • Concurrent systemic corticosteroid therapy within 4 weeks prior to randomization, except prophylactic use of steroids prior to paclitaxel administration
  • 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 for 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706862

Contacts
Contact: Yenyun Wang, MD 713-552-1091 ywang@agennix.com
Contact: Rajesh Malik, MD 713-552-1091 rmalik@agennix.com

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Principal Investigator: Karen Reckamp         
United States, Illinois
Rush University Medical Center Withdrawn
Chicago, Illinois, United States, 60612
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Principal Investigator: Missak Haigentz         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Jeffrey Crawford         
United States, Tennessee
Chattanooga Oncology and Hematology Associates Recruiting
Chattanooga, Tennessee, United States, 37404
Principal Investigator: Davey Daniel         
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: David Spigel         
Sponsors and Collaborators
Agennix
  More Information

No publications provided

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00706862     History of Changes
Other Study ID Numbers: LF-0208
Study First Received: June 26, 2008
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Agennix:
Non small cell lung cancer
Talactoferrin
Dendritic cell recruiter and activator
DCRA
Immunomodulatory agent
Lactoferrin

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014