E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Wild-type K-ras metastatic colorectal cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052362 |
E.1.2 | Term | Metastatic colorectal cancer |
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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 estimate the objective response rate in wild-type k-ras, metastatic colorectal cancer patients treated with panitumumab in combination with capecitabine/oxaliplatin as first-line therapy. |
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E.2.2 | Secondary objectives of the trial |
Evaluation of 1. The progression-free survival 2. The overall survival 3. The safety profile 4. The total cost of the combination |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients will be eligible to participate in the study if they meet all of the criteria listed below: 1. Ability to comprehend and sign an informed consent 2. Aged 18 years or more 3. Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum 4. Measurable disease according to the RECIST criteria 5. Eastern Cooperative Oncology Group (ECOG) status of 0-2 6. Non-mutated k-ras gene (k-ras status will be assessed by DNA sequencing in codons 12 and 13) 7. Haematologic function: ANC >1.5 x 109/L, Leucocyte count >3000/mm3, Haemoglobin >10g/ d L, PLT >100 x 109/ L 8. Renal function: serum creatinine ≤1.5xUNL or creatinine clearance > 50ml/min 9. Hepatic function: o Total bilirubin ≤ 1.5 time the upper normal limit (UNL) o ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases o ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases 10. Metabolic function: o Magnesium ≥ lower limit of normal. o Calcium ≥ lower limit of normal.
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E.4 | Principal exclusion criteria |
Any patient with any of the criteria listed below will be excluded from the study: 1. Central nervous system metastases 2. Prior therapy for metastatic disease 3. Adjuvant chemotherapy for the last 6 months 4. Prior anti-EGFR therapy or treatment with EGFR tyrosine kinase inhibitors 5. Prior radiotherapy within 30 days from enrollment 6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) £ 1 year before enrollment 7. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. 8. Inflammatory bowel disease or chronic diarrhea 9. Dihydropyrimidine deficiency 10. Positive test for HIV infection, hepatitis C infection, chronic active hepatitis B infection 11. Any kind of disorder compromising the ability of the patient to give informed consent 12. Any investigational agent within 30 days prior to initiation of the study 13. Any surgical procedure within 28 days prior to initiation of the study 14. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. 15. Female subject in childbearing age with a positive pregnancy test at screening or before initiation of study treatment. 16. Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
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E.5 End points |
E.5.1 | Primary end point(s) |
The objective response rate (ORR) in patients with wild-type k-ras metastatic colorectal cancer |
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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 | Yes |
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 | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
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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The last visit of the last subject |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |