E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
histologically confirmed Metastatic colorectal adenocarcinoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052358 |
E.1.2 | Term | Colorectal cancer metastatic |
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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 assess the objective response rate (ORR) when panitumumab is administered in combination with irinotecan for Patients with Advanced Metastatic Colorectal Cancer without KRAS mutation (Wild type) in third line chemotherapy = Patients pretreated with oxaliplatin and Fluorpyrimidines (5FU/FA or capecitabine) ± bevacizumab and Irinotecan alone or in association with Fluorpyrimidines (5FU/FA or capecitabine) ± bevacizumab |
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E.2.2 | Secondary objectives of the trial |
To assess the combination therapy of panitumumab plus irinotecan on other efficacy measures in this population : disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), time to progression (TTP), time to treatment failure (TTF), duration of stable disease (DoSD). To assess in this population the efficacy and safety of the treatment strategy of combination therapy of panitumumab plus irinotecan, followed by panitumumab alone for subjects who discontinue irinotecan as third line therapy due to toxicity in subjects with previously treated metastatic colorectal cancer.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Ancillary study n°1 : Translational research with blood sample:A blood samples (20ml EDTA) will been sent for genotype and phenotype of polymorphism of EGFR on normal cells (Lymphocytes) to test a possible relation between expression of EGFR gene, skin toxicity and response Ancillary study n°2: Skin study Primary Objective (a) test whether a positive cutaneous reaction to a intra dermal injection of panitumumab is associated with a later response of the tumour, Secondary objective (b) test whether a positive cutaneous reaction to a intra dermal injection of panitumumab is associated with a higher incidence and severity of later cutaneous reactions.
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E.3 | Principal inclusion criteria |
• Histologically confirmed metastatic adenocarcinoma of the colon or rectum by the Investigator. • Wild Type KRAS (no mutation) by allelic discrimination on tumor DNA • Prior chemotherapy regimens for mCRC with oxaliplatin and Fluorpyrimidines (5FU/FA or capecitabine) ± Bevacizumab and Irinotecan alone or in association with Fluorpyrimidines (5FU/FA or capecitabine) ± Bevacizumab • At least 1 uni-dimensionally measurable lesion of at least 10 mm per modified-RECIST criteria (All sites must be evaluated ≤ 28 days prior to the enrolment). • Prior radiotherapy is acceptable. It must be at least 14 days since administration of radiation therapy and all signs of early toxicity must have abated. • World Health Organisation (WHO) performance status of 0, 1 or 2
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E.4 | Principal exclusion criteria |
• Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia (treated or not) • Presence of KRAS mutation by allelic discrimination on tumor DNA • Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (eg, erlotinib). Subjects who discontinue their first dose of anti-EGFR therapy (cetuximab) because of an infusion reaction may participate in this clinical trial. • Prior radiotherapy within 14 days since administration of radiation therapy to enrollment. All signs of early toxicity must have abated. • Metastases of the central nervous system • Pregnancy ; breast feeding
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E.5 End points |
E.5.1 | Primary end point(s) |
• Objective response rate (ORR) during the combination therapy phase: Incidence of either a radiologically confirmed CR or PR while in the combination treatment phase; subjects prematurely discontinuing without a post baseline tumour response assessment, or subjects who respond during the optional panitumumab monotherapy phase, or subjects with an observed CR or PR in the combination phase that is not confirmed (in either the combination or monotherapy phases) will be considered non-responders. |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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 | |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | |