metastatic colorectal carcinoma MedDRA version: 9.1 Level: LLT Classification code 10010036 Term: Colorectal carcinoma MedDRA version: 9.1 Level: LLT Classification code 10027477 Term: Metastatic carcinoma
Conditions
Interventions
Product Name: MK-0646
Pharmaceutical Form: Solution for infusion
CAS Number: n/a
Current Sponsor code: MK-0646
Other descriptive name: humanized monoclonal antibody against insulin-like growth factor
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has histologically or cytologically confirmed colorectal cancer. 2. Patient has at least one measurable lesion greater than or equal to 20 mm. 3. Patient has previously failed both irinotecan and oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy with objective radiological evidence of progression. 4. Patient is male or female, and =18 years of age on the day of signing informed consent. 5. Patient has performance status 0-1 on the ECOG Performance Scale. 6. Patient has adequate organ function as indicated by the following laboratory values: Absolute Neutrophil Count (ANC) =1,500/mcL Platelets =100,000/mcL Hemoglobin =9 g/dL-without qualifications, use of erythropoietin and transfusions are allowed Serum Creatinine/calculated creatine clearance =2 times the upper limit of normal (ULN)/ =60 mL/min (patients with creatinine levels =2 times the ULN). Patient may not be on dialysis. (Creatinine clearance should be calculated per institutional standard.) Serum total bilirubin =1.5 times the ULN AST (SGOT) and ALT (SGPT) =5 times the ULN Prothrombin time (PT) =1.2 times the ULN Partial Thromboplastin time (PTT) =1.2 times the ULN 7. Patient has archival tumor available for analysis for biomarker studies. 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 ;Inclusion criteria: 1. Patient has histologically or cytologically confirmed colorectal cancer. 2. Patient has at least one measurable lesion greater than or equal to 20 mm. 3. Patient has previously failed both irinotecan and oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy with objective radiological evidence of progression. 4. Patient is male or female, and =18 years of age on the day of signing informed consent. 5. Patient has performance status 0-1 on the ECOG Performance Scale. 6. Patient has adequate organ function as indicated by the following laboratory values: Absolute Neutrophil Count (ANC) =1,500/mcL Platelets =100,000/mcL Hemoglobin =9 g/dL-without qualifications, use of erythropoietin and transfusions are allowed Serum Creatinine/calculated creatine clearance =2 times the upper limit of normal (ULN)/ =60 mL/min (patients with creatinine levels =2 times the ULN). Patient may not be on dialysis. (Creatinine clearance should be calculated per institutional standard.) Serum total bilirubin =1.5 times the ULN AST (SGOT) and ALT (SGPT) =5 times the ULN Prothrombin time (PT) =1.2 times the ULN Partial Thromboplastin time (PTT) =1.2 times the ULN 7. Patient has archival tumor available for analysis for biomarker studies. 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
Exclusion criteria
Exclusion criteria: 1. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to initial dosing on this study or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline. 2. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the investigational agent, whichever is longer, of initial dosing on this study. 3. Patient has experienced intolerable toxicity to irinotecan therapy. 4. Patient has prior exposure to IGF-1R inhibitors or EGFR inhibitors (e.g. cetuximab). 5. Patient has CNS metastases and/or carcinomatous meningitis. 6. Patient has primary central nervous system tumor. 7. Patient has a known hypersensitivity to the components of study drugs or its analogs that is not treatable by premedication with antihistamines and steroids. 8. Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate. 9. Patient with a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with PSA <1.0; who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk for recurrence by his/her treating physician. 10. Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study. 11. Patient is known to be Human Immunodeficiency Virus (HIV)-positive. 12. Patient has known active Hepatitis B or C. 13. Patient has symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible. 14. Patient is concurrently using growth hormone (GH), or growth hormone inhibitors. ;Exclusion criteria: 1. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to initial dosing on this study or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline. 2. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the investigational agent, whichever is longer, of initial dosing on this study. 3. Patient has experienced intolerable toxicity to irinotecan therapy. 4. Patient has prior exposure to IGF-1R inhibitors or EGFR inhibitors (e.g. cetuximab). 5. Patient has CNS metastases and/or carcinomatous meningitis. 6. Patient has primary central nervous system tumor. 7. Patient has a known hypersensitivity to the components of study drugs or its analogs that is not treatable by premedication with antihistamines and steroids. 8. Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate. 9. Patient with a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with PSA <1.0; who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk for recurrence by his/her treating physician. 10. Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study. 11. Patient is known to be Human Immunodeficiency Virus (HIV)-positive. 12. Patient has known active Hepatitis B or C. 13. Patient has symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible. 14. Patient is concurrently using growth hormone (GH), or growth hormone inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine overall survival of patients with metastatic colorectal cancer treated with the combination of MK-0646, cetuximab, and irinotecan compared to patients treated with cetuximab and irinotecan alone. 2. To evaluate progression-free survival of patients with metastatic colorectal cancer treated with the combination of MK-0646, cetuximab, and irinotecan compared to patients treated with cetuximab and irinotecan alone. 3. To assess the safety profile of MK-0646 in combination with cetuximab and irinotecan. ;Secondary Objective: To evaluate the objective response rate of patients with metastatic colorectal cancer treated with the combination of MK-0646, cetuximab and irinotecan compared to patients treated with cetuximab and irinotecan alone.;Primary end point(s): The primary clinical endpoints will be PFS and OS.;Main Objective: 1. To determine overall survival of patients with metastatic colorectal cancer treated with the combination of MK-0646, cetuximab, and irinotecan compared to patients treated with cetuximab and irinotecan alone. 2. To evaluate progression-free survival of patients with metastatic colorectal cancer treated with the combination of MK-0646, cetuximab, and irinotecan compared to patients treated with cetuximab and irinotecan alone. 3. To assess the safety profile of MK-0646 in combination with cetuximab and irinotecan. ;Secondary Objective: To evaluate the objective response rate of patients with metastatic colorectal cancer treated with the combination of MK-0646, cetuximab and irinotecan compared to patients treated with cetuximab and irinotecan alone.;Primary end point(s): The primary clinical endpoints will be PFS and OS. | — |
Countries
Austria, Belgium, Denmark, Finland, France, Germany, Italy, Lithuania, Netherlands, Spain, Sweden, United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed