| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| metastatic colorectal cancer |
| tumore del colon retto, metastatico |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10055114 |
| E.1.2 | Term | Colon cancer metastatic |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| 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 |
| 1. To determine overall survival of patients with metastatic colorectal cancer treated with the combination of MK-0646, cetuximab, and irinotecan compared to patients treated with cetuximab and irinotecan alone. 2. To evaluate progression-free survival of patients with metastatic colorectal cancer treated with the combination of MK-0646, cetuximab, and irinotecan compared to patients treated with cetuximab and irinotecan alone. |
| 1) valutare la sopravvivenza di pazienti di pazienti con cancro metastatico colon rettale trattati con MK0646 associato a cetuximab e irinotecan rispetto ai pazienti trattati con cetuximab e irinotecan da soli 2)valutare la durata del periodo libero da malattia di pazienti con cancro metastatico colon rettale trattati con MK0646 associato a cetuximab e irinotecan rispetto ai pazienti trattati con cetuximab e irinotecan da soli |
|
| E.2.2 | Secondary objectives of the trial |
| To evaluate the objective response rate of patients with metastatic colorectal cancer treated with the combination of MK-0646, cetuximab and irinotecan compared to patients treated with cetuximab and irinotecan alone |
| valutare il tasso di risposta di pazienti di pazienti con cancro metastatico colon rettale trattati con MK0646 associato a cetuximab e irinotecan rispetto ai pazienti trattati con cetuximab e irinotecan da soli |
|
| 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 |
PHARMACOGENETIC:
Vers:
Date:
Title:
Objectives:
|
FARMACOGENETICA:
Vers:
Data:
Titolo:
Obiettivi:
ALTRI SOTTOSTUDI:
analisi dell'espressione di IGF-1R tramite prelievo bioptico cutaneo o paracentesi
|
|
| E.3 | Principal inclusion criteria |
| Patients must meet all of the following criteria to participate in the study: 1. Patient has histologically or cytologically confirmed colorectal cancer. 2. Patient has at least one measurable lesion greater than or equal to 20 mm. 3. Patient has previously failed both irinotecan and oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy with objective radiological evidence of progression. 4. Patient is male or female, and ≥18 years of age on the day of signing informed consent. 5. Patient has performance status 0-1 on the ECOG Performance Scale. 6. Patient has adequate organ function as indicated by the following laboratory values: 0646, Protocol 004-00 Issue Date: 17-May-2007 16 Product: MK-0646 8 Protocol/Amendment No.: 004-00 0646_004-00_ProtCore VERSION 4.0 APPROVED 17-May-2007 Worldwide Restricted Confidential - Limited Access System Laboratory Value Hematological Absolute Neutrophil Count (ANC) ≥1,500/mcL Platelets ≥100,000/mcL Hemoglobin ≥9 g/dL-without qualifications, use of erythropoietin and transfusions are allowed Renal Serum Creatinine/calculated creatine clearancea ≤2 times the upper limit of normal (ULN)/ ≥60 mL/min (patients with creatinine levels ≥2 times the ULN). Patient may not be on dialysis. Hepatic Serum total bilirubin ≤1.5 times the ULN AST (SGOT) and ALT (SGPT) ≤5 times the ULN Coagulation Prothrombin time (PT) Partial Thromboplastin time (PTT) ≤1.2 times the ULN ≤1.2 times the ULN a Creatinine clearance should be calculated per institutional standard. 7. Female patient of childbearing potential has a negative serum or urine β-hCG pregnancy test at baseline. 8. Patient, or patient's legal representative, has voluntarily agreed to participate by giving written informed consent. 9. Patient has archival tumor available for analysis for biomarker studies. |
| pazienti sia maschi che femmine, con eta' uguale o superiore a 18 anni - pazienti con diagnosi citologica o istologica di carcinoma del colon-retto - pazienti affetti da malattia metastatica con almeno una lesione neoplastica misurabile ugua- le o superiore a 20 mm di diametro - pazienti con evidenza radiologica di progressione di malattia dopo o durante un trattamento a base di oxaliplatino e irinotecan - pazienti in buone o discrete condizioni cliniche generali (Performance status/ECOG: 0 - 1) - pazienti con adeguata funzionalita' d'organo (ematologica, renale ed epatica) - donne potenzialmente fertili con test di gravidanza negativo - pazienti che avranno letto, compreso e firmato il consenso informato scritto. |
|
| E.4 | Principal exclusion criteria |
| A patient meeting any of the following criteria is not eligible to participate in this study: 1. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to initial dosing on this study or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline. 2. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the investigational agent, whichever is longer, of initial dosing on this study. 3. Patient has experienced intolerable toxicity to irinotecan therapy. 4. Patient has prior exposure to IGF-1R inhibitors or EGFR inhibitors (e.g. cetuximab). 0646, Protocol 004-00 Issue Date: 17-May-2007 17 Product: MK-0646 9 Protocol/Amendment No.: 004-00 0646_004-00_ProtCore VERSION 4.0 APPROVED 17-May-2007 Worldwide Restricted Confidential - Limited Access 5. Patient has CNS metastases and/or carcinomatous meningitis. 6. Patient has primary central nervous system tumor. 7. Patient has a known hypersensitivity to the components of study drugs or its analogs that is not treatable by premedication with antihistamines and steroids. 8. Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate. 9. Patient with a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with PSA <1.0; who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk for recurrence by his/her treating physician. 10. Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 11. Patient is, at the time of signing informed consent, a regular user (including recreational use) of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse. 12. Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study. 13. Patient is known to be Human Immunodeficiency Virus (HIV)-positive. 14. Patient has known active Hepatitis B or C. 15. Patient has symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible. 16. Patient is concurrently using growth hormone (GH), or growth hormone inhibitors. |
| pazienti che hanno ricevuto chemioterapia, radioterapia o terapie biologiche nelle 2 settima- ne precedenti alla dose iniziale del farmaco in studio - pazienti che partecipano o abbiano partecipato negli ultimi 30 giorni ad altri studi sperimen- tali - pazienti che abbiano avuto effetti collaterali gravi e inaccettabili dalla terapia con irinotecan - pazienti gia' trattati con anti-IGF-1R o anti-EGFR (per es. cetuximab) - pazienti con tumore primitivo o secondario del sistema nervoso centrale e/o con carcinosi meningea - pazienti in terapia con ormone della crescita o con suoi inibitori - pazienti con malattie psichiatriche o tossicodipendenze tali da interferire con la corretta ade- sione al protocollo dello studio - donne in gravidanza o allattamento - pazienti con ascite o effusione pleurica sintomatiche e non controllate dalla terapia |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| 1)survival 2)progrssion free survival |
| 1)sopravvivenza 2) durata del periodo libero da malattia |
|
| 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 | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | Yes |
| 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 |
| fase II/III il protocollo prevede due fasi di studio |
|
| 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 | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| 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 | Yes |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| - Stesso farmaco ad altro dosaggio |
| - same IMP used at different dosage |
|
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| 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 | 4 |
| 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 | No |
| 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
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 24 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 24 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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