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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00707304
Recruitment Status : Completed
First Posted : June 30, 2008
Last Update Posted : August 21, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Talactoferrin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 742 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Overall survival [ Time Frame: After the occurence of the required number of events ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: At time of final analysis ]
  2. Objective response and disease stablization rate [ Time Frame: At time of final analysis ]
  3. Safety and tolerability [ Time Frame: At time of final analysis ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00707304

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Responsible Party: Agennix Identifier: NCT00707304     History of Changes
Obsolete Identifiers: NCT00937209
Other Study ID Numbers: LF-0207
First Posted: June 30, 2008    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 2012

Keywords provided by Agennix:
Non Small Cell Lung Cancer
Dendritic Cell Recruiter and Activator
Immunomodulatory agent

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