A PHASE II / III STUDY OF TREATMENT WITH MK-0646 IN COMBINATION WITH CETUXIMAB AND IRINOTECAN FOR PATIENTS WITH METASTASIC COLORECTAL CANCER
- Conditions
- -C18 Malignant neoplasm of colonMalignant neoplasm of colonC18
- Registration Number
- PER-113-07
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 8
• The patient has histologically or cytologically confirmed colorectal cancer.
• The patient has at least one measurable lesion greater than or equal to 20 mm.
• The patient has previously failed regimens containing irinotecan and oxaliplatin and should have evolved within 3 months of completing his last line of therapy with evidence of objective radiological evolution as verified by previous radiological tomography.
• The patient is male or female, and> 18 years of age on the day of signing the informed consent.
• The patient has a performance status of 0-1 on the Performance Scale according to the ECOG.
• The patient has an adequate organ function
• The potently fertile patient has a serum pregnancy test or p-hCG in urine with a negative result at baseline.
• The patient, or the legal representative of the patient, has voluntarily accepted to participate by giving their written informed consent.
• The patient has archival tumor available for analysis in studies with biomarkers.
• The patient has undergone chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to the initial dose in this study or whose toxicities by agents administered 2 weeks before have not disappeared to at least grade 1 or baseline.
• The patient is currently participating or has participated in a study with a compound or device under investigation within 30 days or 5 half lives of the research agent, including the longest one, from the initial dose of this study.
• The patient has experienced an intolerable toxicity to irinotecan therapy.
• The patient has previous exposure to IGF-IR inhibitors or EGFR inhibitors (for example cetuximab).
• The patient has known metastasis in the CNS and / or carcinomatous meningitis.
• The patient has a primary tumor to the central nervous system.
• The patient has a known hypersensitivity to the components of study drugs or their analogues that can not be treated by premedication with antihistamines and steroids.
• The patient has a current history or evidence of a condition, therapy, or laboratory abnormality that could confuse the results of the study, interfere with the patient´s participation for the entire duration of the study, or the patient does not have the best interest to participate .
• The patient has a history of previous malignancy with the exception of intraepithelial neoplasia to the cervix; basal cell carcinoma of the skin; carcinoma located in the prostate treated adequately with PSA <1.0; has been subjected to potent curative therapy without evidence of this disease for five years, or is considered low risk to return to go according to his treating physician.
• The patient has known psychiatric or substance abuse disorders that would interfere with the cooperation with the test requirements.
• At the time of signing the informed consent, the patient is a regular user (including recreational use) of licit drugs or has had a recent history (within the last year) of drug or alcohol abuse.
• The patient is pregnant or nursing, or expects to conceive within the projected duration of the study.
• The patient is known to be positive for the Human Immunodeficiency Virus (HIV).
• The patient has active Hepatitis B or C known.
• The patient has ascites or symptomatic pleural effusions. A patient who is clinically stable after treatment for these conditions is already eligible.
• The patient is simultaneously using growth hormones (GH), or inhibitors of; growth hormone.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method