A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Chemotherapy to the Efficacy of Chemotherapy Alone in Patients with Previously Treated Metastatic Colorectal Cancer - ND

Active, not recruiting

• Conditions: /A; MedDRA version: 6.1Level: PTClassification code 10052358

• Registration Number: EUCTR2005-004676-20-IT
• Lead Sponsor: AMGEN S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-31
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

A Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease One and only one prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine-based chemotherapy. Prior adjuvant fluoropyrimidine-based chemotherapy is allowed Radiographically documented disease progression per modified RECIST criteria either while receiving or 6 months after the last dose of prior first-line fluoropyrimidine-based chemotherapy for mCRC At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST criteria. All sites of disease must be evaluated 28 days prior to enrollment Eastern Cooperative Oncology Group ECOG performance status of 0, 1, or 2 Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses of EGFr and biomarker testing Man or woman 18 years of age Hematologic function, as follows 7 days of randomization o Absolute neutrophil count ANC 1.5 x 109/L o Platelet count 100 x 109/L o Hemoglobin 9 g/dL Renal function, as follows 7 days of randomization o Creatinine 1.5 x upper limit of normal ULN Hepatic function, as follows 7 days of randomization o Aspartate aminotransferase AST 3 x ULN if liver metastases 5 x ULN o Alanine aminotransferase ALT 3 x ULN if liver metastases 5 x ULN o Total bilirubin 1.5 x ULN Metabolic function, as follows 7 days of randomization o Magnesium lower limit of normal Negative pregnancy test 72 hours of randomization females of childbearing potential only Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form Life expectancy 3 months
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

History or known presence of central nervous system CNS metastases History of another primary cancer, except o Curatively treated in situ cervical cancer, or o Curatively resected non-melanoma skin cancer, or o Other primary solid tumor curatively treated with no known active disease present and no treatment administered for 5 years prior to randomization Prior irinotecan therapy Prior anti-EGFr antibody therapy eg, cetuximab or treatment with small molecule EGFr inhibitors eg, erlotinib Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved proteins/antibodies eg, bevacizumab 30 days before randomization Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for randomization Radiotherapy 14 days prior to randomization. Patients must have recovered from all radiotherapy-related toxicities Active infection requiring systemic treatment or any uncontrolled infection 14 days prior to randomization CYP3A4 enzyme inducing anti-convulsant medication eg phenytoin, phenobarbital or carbamazepine , rifampin and rifabutin, and St. John s Wort 14 days before randomization Ketoconazole 7 days before randomization Itraconazole should be used with caution

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified