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

June 26, 2008
March 13, 2012
February 2009
June 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00706862 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Talactoferrin in Addition to Standard Chemotherapy in Patients With Non-small Cell Lung Cancer
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • Drug: Talactoferrin
    Oral, 1.5 grams twice per day
    Other Names:
    • talactoferrin alfa
    • TLF
    • recombinant human talactoferrin
    • rhLF
  • Drug: Placebo
    Oral, twice per day
  • Experimental: 1
    Talactoferrin, Carboplatin, Paclitaxel
    Intervention: Drug: Talactoferrin
  • Placebo Comparator: 2
    Placebo, Carboplatin, Paclitaxel
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1100
March 2016
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Yenyun Wang, MD 713-552-1091 ywang@agennix.com
Contact: Rajesh Malik, MD 713-552-1091 rmalik@agennix.com
United States
 
NCT00706862
LF-0208
Yes
Agennix
Agennix
Not Provided
Not Provided
Agennix
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP