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

• Register: EUCTR
• Last refreshed on: 3 April 2012
• Main ID: EUCTR2005-004676-20-IT
• Date of registration: 31/01/2007
• Prospective Registration: No
• Primary sponsor: AMGEN S.P.A.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 06/07/2006
• Target sample size: 1100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004676-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Con chemioterapia standard

Countries of recruitment

Austria, Czech Republic, Finland, Ireland, Italy, Lithuania, Netherlands, Portugal, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

N/A
MedDRA version: 6.1 Level: PT Classification code 10052358

Intervention(s)

Trade Name: Panitumumab
Product Name: PANITUMUMAB
Product Code: AMG954
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: VARI
Current Sponsor code: 20050181
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-

Primary Outcome(s)

Main Objective: To evaluate the treatment effect of Panitumumab plus Folfiri on overall survival OS and progression free survival PFS compared to Folfiri alone as second line therapy for metastatic colorectal cancer.

Primary end point(s): Efficacy overall survival OS and progression free survival PFS

Secondary Objective: To evaluate overall objective response rate ORR , time to progression TTP duration of response DOR and safety incidence of AEs and significant laboratory changes .

Secondary ID(s)

Panitumumab 20050181

2005-004676-20-CZ