None listed
Conditions
Interventions
Patients will be given an infusion of 10 mg / kg of MK-0646 for 60 minutes.
Group name:Arm C Type of group
The MK-0646 will be replaced by saline. This saline placebo will be referred to hereinafter as placebo
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:defined as the time from randomization to death due to any cause. Patients without, death documented at the time of the final analysis will be counted on the date of the last follow-up. Measure:General survival Timepoints:until the date of the last follow-up. ; Outcome name:defined as the time from randomization to the first documented evolution of the disease, as documented by an independent central laboratory, or death due to any cause, whichever occurs first. Measure:Survival without evolution Timepoints:to the first documented evolution of the disease, as documented by an independent central laboratory, or death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:defined as the proportion of patients in the analysis population that have complete response (CR) or partial response (PR) during the course of the study. The confirmation of the response will require a second evaluation at 4 weeks or more after the initial evaluation. Measure:target response rate Timepoints:4 weeks | — |
Contacts
Public ContactSTELA Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed