A double-blind, randomized, comparative, multicenter, exploratory, and placebo-controlled Phase II trial of FOLFIRI plus MSC1936369B or placebo with a safety run-in part as second-line treatment of metastatic K-Ras mutated colorectal cancer subjects - ND
- Conditions
- METASTATIC COLORECTAL CANCER (SECOND LINE)MedDRA version: 12.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer
- Registration Number
- EUCTR2009-015621-36-IT
- Lead Sponsor
- MERCK SERONO SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 196
SAFETY RUN-IN PART AND PHASE II RANDOMIZED PART 1. Histologically confirmed K-Ras mutated colon/rectum cancer. 2. Subject s disease must have progressed during or after a first-line treatment for metastatic disease with oxaliplatin and fluoropyrimidins based chemotherapy with or without bevacizumab. 3. Evidence of metastatic measurable disease at trial entry as per Response Evaluation Criteria in Solid Tumors [RECIST v1.0] (at least one measurable lesion). Complete tumor assessment performed within 14 days prior to first trial drug administration. 4. Male / female subjects aged ≥ 18 years. 5. Subject has read, understood and given written informed consent, fully understands requirements of the trial, and is willing to comply with all trial visits and assessments. Consent must be given before any trial related activities. 6. Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For the purposes of this trial, women of childbearing potential are defined as: All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive. 7. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to screening, during and four weeks after the last dose of trial medication. Adequate contraception is defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device or use of oral female contraceptive (unless there is a reason by the Investigator to believe that MSC1936369B may interact with this last method).
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
SAFETY RUN-IN PART AND PHASE II RANDOMIZED PART 1. Bone marrow impairment as evidenced by hemoglobin < 9.0 g/dL, neutrophil count < 1.5 x 109/L, and/or platelets < 100 x 109/L. 2. Renal impairment as evidenced by serum creatinine > 1.5 x ULN (upper limit of normal) and/or calculated creatinine clearance < 50 mL/min. 3. Liver function and liver cell integrity abnormality as defined by total bilirubin > 1.5 x ULN, or AST/ALT >2.5 x ULN, for subjects with liver involvement AST/ALT > 5 x ULN. 4. History of central nervous system (CNS) metastases,unless subject has been previously treated for CNS metastases, is stable by CT scan without evidence of cerebral edema, and has no requirements for corticosteroids or anticonvulsants. 5. History of difficulty of swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product. 6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than 1. 7. Known HIV positivity, active hepatitis C, or active hepatitis B. 8. Has received extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation. Prior radiation for local disease management is allowed if last fraction was completed at least 4 weeks prior to trial entry. 9. Has received chemotherapy, any investigational drug, or having participated in an other clinical trial within the past 4 weeks prior to trial first drug administration. 10. Has a history of any other significant medical disease such as major gastric or small bowel surgery, or has a psychiatric condition that might impair the subject s well-being or preclude full participation in the trial. 11. Past or current history (within the last 2 years prior to inclusion) of malignancies except for the indication under this study and curatively treated: basal and squamous cell carcinoma of the skin and in-situ carcinoma of the cervix. 12. Has significant cardiac conduction abnormalities and/or pacemaker. 13. Is a pregnant or nursing female. 14. Has retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), history of uveitis, or history of retinal vein occlusion. 15. Other significant disease that in the Investigator s opinion would exclude the subject from the trial. 16. Known hypersensitivity to the trial treatment(s) or diluents (when applicable), including placebo or other comparator drug(s). 17. Legal incapacity or limited legal capacity.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method