Safety and Efficacy of Talactoferrin in Previously Treated Patients WithNon-small Cell Lung Cancer

Conditions: on-small cell lung cancer in patients who have failed two or more prior treatment regimens.
MedDRA version: 14.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-012709-20-CZ

Lead Sponsor: Agennix Incorporated

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 742

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
occurred
4. At least one target lesion that is unirradiated and measurable by
RECIST
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
protocol
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
treatment
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