E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Histopathologically confirmed renal cell carcinoma with metastases. |
Tumore renale metastatico a cellule chiare istopatologicamente confermato |
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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 | LLT |
E.1.2 | Classification code | 10038415 |
E.1.2 | Term | Renal cell carcinoma stage unspecified |
E.1.2 | System Organ Class | 100000004864 |
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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 |
The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC given all of the following conditions are met: a. Patients are ineligible for participation in ongoing SU011248 clinical studies (if any Phase 1, 2 or 3 SU011248 protocols for patients having RCC are open to enrollment at the institution) except for those patients who received IFN-α therapy in Protocol A6181034 and either had radiographic documentation of disease progression or were IFN-α intolerant, and; b. Patients have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator. |
Consentire il trattamento con SU011248 ai pazienti con tumore renale cellulare metastatico che abbiano le seguenti caratteristiche: - pazienti sono ineleggibili per partecipare ad altri studi ongoing con SU011248 (nel caso fossero aperti per l`arruolamento presso l`Istituto altri studi con SU011248 di fase 1, 2 0 3 per soggetti da tumore renale cellulare citochine-refrattario) eccetto i soggetti che hanno ricevuto, nel protocollo A6181034, terapia IFN-alpha e hanno avuto o progressione della malattia documentata da radiografie o risultavano intolleranti al IFN-alpha e - pazienti che, a giudizio dello sperimentatore possono trarre beneficio dal trattamento con SU011248 |
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E.2.2 | Secondary objectives of the trial |
Safety and tolerability profile of SU011248; The antitumor efficacy of single-agent SU011248 given orally at a dose of 50 mg in patients with metastatic RCC. |
-Profilo della sicurezza e tollerabilita` di SU011248- L`efficacia antitumorale di SU011248 somministrato oralmente come agente singolo ad una dose di 50mg in pazienti con tumore renale cellulare citochine-refrattario |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histopathologically confirmed renal cell carcinoma with metastases. 2. Must be ineligible for participation in ongoing SU011248 clinical studies (if any Phase 1, 2 or 3 SU011248 protocols for patients having RCC are open to enrollment at the institution). 3. Judged by the treating physician to have the potential to derive clinical benefit from SU011248 treatment. 4. Male or female, 18 years of age or older. 5. If previously treated for metastatic RCC, resolution of all acute toxic effects of prior systemic therapy, radiotherapy or surgical procedure to NCI CTCAE Version 3.0 Grade ≤1 (Appendix 3). 6. Adequate organ function as defined by the following criteria: Total serum bilirubin ≤2 x ULN (patients with Gilbert's disease exempt); Serum transaminases <5 x ULN; Serum creatinine ≤2 x ULN; Absolute neutrophil count (ANC) ≥1000/mm3 without growth factor support; Platelets ≥75,000/mm3; Hemoglobin ≥8.0 g/Dl. 7. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. 8. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures. 9. As required by local regulations, eg, United Kingdom, ECOG performance status of 0, 1 or 2. |
1. Adenocarcinoma renale metatstatico istopatologicamente confermato 2.ineleggibili per partecipare ad altri studi ongoing con SU011248 (nel caso fossero aperti per l`arruolamento presso l`Istituto altri studi con SU011248 di fase 1, 2 0 3 per soggetti da tumore renale cellulare citochine-refrattario) 3.Pazienti che a giudizio dello sperimentatore possano avere un beneficio clinico dal trattamento con SU01248 4.Pazienti di sesso maschile o femminile di eta` >18 anni 5.Risoluzione di tutti gli eventi tossici acuti derivanti da precedenti terapie sistemiche, radioterapia o interventi chirurgici secondo NCI CTCAE version 3.0 grado <1 6. Adeguata funzionalita` d'organo come definita dai seguenti criteri: o Bilirubina totale </= 2 x ULN (eccetto I pazienti con malattia di Gilbert) o AST e ALT < 5 x ULN o Creatinina sierica </=2 x ULN o Conta assoluta dei neutrofili (ANC) >/= 1000/mL senza il supporto dei fattori di crescita o Piastrine >/= 75,000/mL o Emoglobina >/= 8,0 g/dL 7. Pazienti che hanno dato il consenso informato scritto per partecipare allo studio 8. Volonta` e capacita` di rispettare le visite programmate, terapia, test di laboratorio ed altre procedure previste dal protocollo. |
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E.4 | Principal exclusion criteria |
1. Current treatment in another therapeutic clinical trial. 2. Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina or any unstable arrhythmia requiring medication. 3. Previous treatment on a SU011248 trial except for those patients who received IFN-α therapy in Protocol A6181034 and either had radiographic documentation of disease progression or were IFN-α intolerant. 4. Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use effective contraception. 5. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. |
1.Partecipazione in altre sperimentazioni cliniche 2. Insufficienza cardiaca congestizia, infarto del miocardio, bypass coronario nei sei mesi precedenti l'arruolamento, angina instabile in corso o aritmie instabile che richiedono una terapia farmacologia. 3. Precedente trattamento con SU011248 in uno studio clinico eccetto per quei pazienti in progressione di malattia documentata radiograficamente, tratttati IFN-alpha nel Protocollo A6181034. 4.Gravidanza o allattamento 5.Altre malattie gravi in fase acuta o cronica o condizioni psichiatriche, o alterazione dei valori di laboratorio che possano aumentare i rischi associati alla partecipazione allo studio o alla somministrazione del farmaco o che a giudizio dello sperimentatore rendano il soggetto non eleggibile. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to provide access to SU011248 treatment for patients with metastatic RCC according to conditions described in the protocol without formal hypothesis testing. In addition, the following clinical endpoints will be evaluated. Safety Profile of SU011248 Overall Survival (OS) Time-To-Progression (TTP) Progression-Free Survival (PFS) Objective Response Rate (ORR) |
L`obiettivo primario e` quello di consentire il trattamento con SU011248 ai pazienti con tumore renale metastatico a cellule chiare in base alle condizioni descritte nel protocollo senza ipotesi statistica formale. In aggiunta verrano valutati i seguenti endpoints: - Profilo della sicurezza di SU011248 -- Sopravvivenza globale - Tempo alla progressione (TTP) - Sopravvivenza senza progressione - Percentuale di risposta obiettiva |
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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 | 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 |
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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) | 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 | 17 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 250 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |