E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052358 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To evaluate overall objective response rate ORR , time to progression TTP duration of response DOR and safety incidence of AEs and significant laboratory changes . |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy overall survival OS and progression free survival PFS |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Con chemioterapia standard |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 2 |