E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
renal cell carcinoma |
carcinoma a cellule renali |
|
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 | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 | 10050513 |
E.1.2 | Term | Metastatic renal cell carcinoma |
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 |
To determine the efficacy of the combination of bevacizumab and Roferon as compared with Roferon and placebo in patients with metastatic RCC, based on overall survival. |
Stabilire lefficacia della ssociazione di bevacizumab e interferone alfa-2a in confronto a interferone alfa-2a e placebo in pazienti con carcinoma a cellule renali metastatico, sulla base della sopravvivenza complessiva |
|
E.2.2 | Secondary objectives of the trial |
To determine the progression free survival, time to disease progression, time to treatment failure and objective response rates of bevacizumab and Roferon as compared with Roferon and placebo. To characterize the safety profile of the combination of bevacizumab and Roferon as compared with Roferon and placebo. To determine the population pharmacokinetics and to explore the pharmacodynamics of bevacizumab and the potential existence of anti-bevacizumab antibody |
Stabilire la sopravvivenza libera da progressione,il tempo alla progressione della malattia,il tempo allinsuccesso terapeutico ed i tassi di risposta obiettiva con bevacizumab e interferone alfa-2a in confronto a interferone alfa-2a e placebo.Caratterizzare il profilo di sicurezza dellassociazione di bevacizumab e interferone alfa-2a versus interferone alfa-2a e placebo.Indagare sulla potenziale esistenza di anticorpi anti-bevacizumab |
|
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 |
PHARMACOKINETIC/PHARMACODYNAMIC: Vers: Date: Title: Objectives:
|
FARMACOCINETICA/FARMACODINAMICA: Vers: Data: Titolo: Obiettivi:
|
|
E.3 | Principal inclusion criteria |
Patients in study BO17705 with metastatic clear cell renal cancer who have had nephrectomy, who participate in the BO17705 Population PK subset, and who are on stable bevacizumab (or placebo) 10 (or 5) mg/kg plus stable interferon alpha-2a treatment. |
Pazienti con tumore a cellule renali metastatico (a cellule chiare) che hanno avuto una nefrectomia |
|
E.4 | Principal exclusion criteria |
1. Prior systemic treatment for metastatic RCC disease (including neo-adjuvant therapy) 2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study 3. Serious non-healing wound, ulcer or bone fracture 4. Evidence of current central nervous system (CNS) metastases or spinal cord compression. Patients must undergo an MRI or CT scan of the brain (with contrast if possible) within 28 days prior to randomization. 5. Seizure(s) not controlled with standard medical therapy 6. Other malignancies within the last 5 years prior to randomisation (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix) 7. Evidence of bleeding diathesis or coagulopathy 8. Ongoing or recent (< 10 days prior to study treatment start) need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin (> 325 mg/day) 9. Uncontrolled hypertension (≥ 160 mm Hg systolic and/or ≥ 90 mm Hg diastolic) while receiving chronic medication 10. Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents and myocardial infarction ( both ≤ 6 months before randomisation), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication 11. Recent (< 30 days prior to randomization) treatment with another investigational drug or participation in another investigational study 12. Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone equivalent), excluding inhaled steroids 13. History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications |
Patients in study BO17705 with metastatic clear cell renal cancer who have had nephrectomy, who participate in the BO17705 Population PK subset, and who are on stable bevacizumab (or placebo) 10 (or 5) mg/kg plus stable interferon alpha-2a treatment. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Non disponibile |
Primario: tempo di sopravvivenza. Secondari: sopravvivenza libera da malattia, tempo alla progressione della malattia, tempo all'insuccesso terapeutico, tasso di risposta globale, stato funzionale (indice di Karnofsky) |
|
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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Placebo+trattamento standard associato (Roferon-A) |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 9 |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |