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Clinical Trials/EUCTR2009-012709-20-CZ
EUCTR2009-012709-20-CZActive, not recruitingNot Applicable

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. - FORTIS-M

Agennix Incorporated0 sites742 target enrollmentStarted: August 10, 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
742
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Main Study:
  • •1. Age = 18 years.
  • •2. Histologically or cytologically confirmed stage IIIB or IV NSCLC
  • •3. Failed at least 2 prior systemic anti-cancer regimens for advanced or
  • •metastatic NSCLC. The following criteria must be satisfied:
  • •Failure is defined as disease progression or unacceptable toxicity
  • •The patient must have received a platinum-containing regimen for advanced or metastatic NSCLC
  • •Failure to the most recent systemic anti-cancer regimen must have
  • •4. At least one target lesion that is unirradiated and measurable by
  • •5. Hemoglobin = 9.0 g/dL
  • •6. Absolute neutrophil count = 2000/mm3
  • •7. Lymphocytes = 800/mm3
  • •8. Platelet count = 100,000/mm3
  • •9. Total bilirubin = 1.5 mg/dL
  • •10. Creatinine = 2.0 mg/dL
  • •11. AST (SGOT) and ALT (SGPT) = 2.5 x the upper limit of normal (ULN)
  • •12. Lactate dehydrogenase = 1.5 x ULN
  • •13. Karnofsky performance status of >50 (ECOG 0, 1, or 2)
  • •14. Life expectancy of >12 weeks
  • •15. Able to understand and sign an informed consent
  • •Extension study:
  • •1. Completed Cycle 5 of study drug in the FORTIS-M (LF-0207) study
  • •2. No evidence of disease progression
  • •3. Overall medical condition sufficient to continue receiving study drug in the judgment of the investigator
  • •4. Able to understand and sign an informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 408
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 334

Exclusion Criteria

  • •Main Study:
  • •1. 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
  • •2. History of allergic reactions to compounds of similar chemical or
  • •biologic composition to talactoferrin
  • •3. Any gastrointestinal tract disease or other medical condition resulting
  • •in the inability to take oral medications
  • •4. 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
  • •5. Uncontrolled ischemic heart disease, or uncontrolled symptomatic
  • •congestive heart failure
  • •6. Serious active infection
  • •7. Psychiatric illness/ social situations that would limit study compliance
  • •8. Other uncontrolled serious chronic disease or conditions that in the
  • •investigator's opinion could affect compliance or follow-up in the
  • •9. 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)
  • •10. Known HIV positive or on active anti-retroviral therapy
  • •11. Known Hepatitis B surface antigen positive or hepatitis C positive
  • •12. Receipt of any systemic anti-cancer regimen or investigational
  • •medication within 4 weeks prior to randomization
  • •13. Pregnant or lactating patients, or fertile female patients with a
  • •positive pregnancy test (serum ß-human chorionic gonadotropin [ß-hCG] at screening or at baseline), or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
  • •14. Sexually active male patients unwilling to practice contraception
  • •while participating on the study and up to 30 days after completion of
  • •15. Legal incapacity or limited legal capacity, unless authorization is
  • •granted by a legal guardian
  • •16. Oral corticosteroid therapy within 4 weeks prior to randomization or
  • •expected to be ongoing during the study, except replacement therapy for adrenal insufficiency
  • •Extension Study:
  • •1. Prior Grade 3 or 4 adverse events attributed to study drug
  • •2. Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications

Investigators

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Safety and Efficacy of Talactoferrin in Previously Treated Patients WithNon-small Cell Lung Cancer
EUCTR2009-012709-20-BGAgennix Incorporated742