Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer (FORTIS-M)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT00707304
First received: June 26, 2008
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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 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-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

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 ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: At time of final analysis ] [ Designated as safety issue: No ]
  • Objective response and disease stablization rate [ Time Frame: At time of final analysis ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: At time of final analysis ] [ Designated as safety issue: Yes ]

Enrollment: 742
Study Start Date: November 2008
Study Completion Date: August 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Oral, 1.5 grams twice per day
Other Names:
  • talactoferrin alfa
  • TLF
  • recombinant human lactoferrin
  • rhLF
Placebo Comparator: 2
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, twice per day

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically confirmed stage IIIB or IV NSCLC
  • Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC
  • At least one target lesion that is unirradiated and measurable by RECIST
  • Adequate hematologic, renal and hepatic function
  • ECOG 0, 1, or 2
  • 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
  • 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 affect compliance or follow-up in the protocol
  • Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
  • 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 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: NCT00707304

  Show 189 Study Locations
Sponsors and Collaborators
Agennix
  More Information

No publications provided

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00707304     History of Changes
Obsolete Identifiers: NCT00937209
Other Study ID Numbers: LF-0207
Study First Received: June 26, 2008
Last Updated: August 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
Immunomodulatory agent

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

ClinicalTrials.gov processed this record on August 28, 2014