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
- Conditions
- on-small cell lung cancer in patients who have failed two or more prior treatment regimens.MedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer
- Registration Number
- EUCTR2009-012709-20-GR
- Lead Sponsor
- Agennix Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 720
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine overall survival.;Secondary Objective: To determine six month and one year survival rate<br>To determine progression-free survival<br>To determine objective tumor response rate<br>To determine disease stabilization rate <br>To assess talactoferrin safety and tolerability <br>;Primary end point(s): Primary Efficacy<br>• Overall Survival (OS)<br><br>Secondary Efficacy<br><br>• Six month and one year survival rate<br>• Progression-Free Survival (PFS)<br>• Objective Response Rate (ORR): radiologically confirmed partial response + complete response (PR+CR) using RECIST<br>• Objective disease stabilization rate (PR+CR+stable disease [SD])<br><br>Safety<br>• Number of adverse events per month while receiving study drugs<br>• Number of Grade 3 or 4 adverse events per month while receiving study drugs<br>• Incidence of Grade 3 or 4 adverse events<br>• Incidence of Grade 3 or 4 pulmonary/upper respiratory adverse events<br>• Incidence of Grade 3 or 4 gastrointestinal adverse events<br>
- Secondary Outcome Measures
Name Time Method