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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

Phase 3
18 Years
Not Enrolling
Non Small Cell Lung Cancer

Thank you

Trial Information

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

Inclusion Criteria:

- Histologically or cytologically confirmed stage IIIB or IV NSCLC

- Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

After the occurence of the required number of events

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2008

Completion Date:

August 2012

Related Keywords:

  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer
  • Talactoferrin
  • Dendritic Cell Recruiter and Activator
  • Immunomodulatory agent
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Washington University School of Medicine Saint Louis, Missouri  63110
Rush University Medical Center Chicago, Illinois  60612-3824
University of Rochester Medical Center Rochester, New York  14642
Montefiore Medical Center Bronx, New York  10467-2490
Tyler Cancer Center Tyler, Texas  75702
Cancer Care Northwest Spokane, Washington  99202
Duke University Medical Center Durham, North Carolina  27710
Arizona Oncology Associates Tucson, Arizona  85712-2254
Emory University Atlanta, Georgia  30322
University of Colorado Hospital Denver, Colorado  80262
Texas Oncology Dallas, Texas  
Pasco Pinellas Cancer Center New Port Richey, Florida  34652
Central Indiana Cancer Centers Indianapolis, Indiana  46227
NH Oncology-Hematology, PA Hooksett, New Hampshire  03106
Alamance Regional Medical Center Burlington, North Carolina  27216
Desert Oasis Cancer Center Casa Grande, Arizona  85222
Southeast Nebraska Cancer Center Lincoln, Nebraska  68510
Cancer Care Specialists of Central Illinois Decatur, Illinois  62256
Cancer Care & Hematology Specialists of Chicagoland Niles, Illinois  60714
Rex Cancer Center Raleigh, North Carolina  27607
Kansas City Cancer Center, LLC Overland Park, Kansas  66210
Signal Point Clinical Research Center Middletown, Ohio  45042
NCI, CCR, The Waren Grant Magnuson Clinical Center Bethesda, Maryland  20892
Newland Medical Associates Southfield, Michigan  48075
Minnesota Oncology and Hematology, PA Minneapolis, Minnesota  55405
Legacy Pharma Research Bismarck, North Dakota  58501
Kaiser Group Health Portland, Oregon  97227
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care Salem, Virginia  24153