E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with advanced or metastatic wild type CRAS, MET high, CRC who have progressed on a previous EGFR inibitor based regimen |
Popolazione pazienti con tumore del colon retto in fase avanzata o metastatica KRAS wild type MET high in progressione ad un regime precedente contenente un inibitore di EGFR |
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E.1.1.1 | Medical condition in easily understood language |
Patients with advance or metastatic colorectal cancer |
Pazienti con tumore del colon retto in fase avanzata o con metastasi |
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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 | HLGT |
E.1.2 | Classification code | 10017990 |
E.1.2 | Term | Malignant and unspecified neoplasms gastrointestinal NEC |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 determine objective response rate (orr) of cetuximab plus tivantinib in patients with Kras wild type CRC that is resistant to EGFR antibody treatment and shows over expression of MET |
determinare il tasso di risposte ORR all'associazione di Cetuximab e Tivantinib in pazienti affetti da mCRC KRAS wild type resstente ad anticorpi anti EGFR e con iperespressione di MET |
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E.2.2 | Secondary objectives of the trial |
to estimate progression-free survival (PFS) robability in the ITT population to estimate overall survival(OS)probability in the ITT population |
tasso di sopravvivenza libera di progressione (PFS) nella popolazione intent to treat (ITT), stiamre tasso soppravvivenza globale n(OS) nella popolazione ITT |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
subjet with surgically unresectablelocally advanced or metastatic disease who have recive at least one prior line of systematic therapies for advanced or metastatic disease, radiological evidence, subjets must have radiologicaly documented disease progression before arrolment subjects must express the wild type form of gene KRAS fresh tumor biopsy tissue available for molecular sequencing and biomarker eor expression age = > 18 years |
soggetti con malattia localmente avanzata non resecabile o metastatica che hanno ricevuto una preceente linea di terapia sistemica per tumore in stato avanzato o metastatico, progressione della malattia documentata radiologicamente, soggetti che esprimano la formula wild type del gene KRAS, disponibilità tessuto fresco per sequienzamento molecolare, iperespressione di MET, età = o maggiore 18 anni |
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E.4 | Principal exclusion criteria |
history of malignancy other then CRC unless there is an exception that the malignancy has been cured and no tumor- specific treatment for the malignancy has been administered within the 3 weeks prior to the initiation, history of cardiac diseade defined as class II-IV per NYHA classification, any condition that is unstable that could jeopardize the safety of the subject |
concomitanti patologie oncologiche, necesità di intervento chirurgico o radioterapia durante lo studio, qualsiasi altro trattamento antitumorale nelle 3 settimane precedenti, malattie cardiache classe II-IV, qualsiasi condizione clinica instabile che possa compromettere la sicurezza del soggetto |
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E.5 End points |
E.5.1 | Primary end point(s) |
ORR objective response rating |
ORR objective response rating |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
4 cicles of therapy |
4 cicli di terapia |
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E.5.2 | Secondary end point(s) |
to estimate proression free survival probability in the ITT population |
tasso di sopravvivenza libera da progressione (pfs) nella popolazione intent to treat (ITT) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 10 |
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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | 0 |