E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ADVANCED RENAL CELL CANCER |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050513 |
E.1.2 | Term | Metastatic renal cell carcinoma |
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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 evaluate the efficacy of the combination of Sorafenib and Interleukin 2 compared with Sorafenib alone in patients with metastatic renal cell carcinoma based on progression free survival |
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E.2.2 | Secondary objectives of the trial |
1. To determine the overall survival, objective response rates of Sorafenib and Interleukin 2 as compared with Sorafenib alone
2. To characterize the safety profile of the combination therapy versus Sorafenib alone |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Signed written informed consent (approved by institutional review board / independent ethics committee)
2.Patient must be willing and able to comply with the protocol
3.Age >= 18 years
4.Patients with cito-hystological diagnosis of renal cell carcinoma (RCC)
5.If the initial diagnosis of RCC is dated more than two years ago,cito- histological confirmation of renal cell carcinoma origin of the current lesions is mandatory
6.Fertile women (<2 years after last menstruation) and men of childbearing potential must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilisation)
7.Measurable disease (as per RECIST criteria)
8.Karnofsky performance status >/= 60%
9.Life expectancy greater than 3 months
10.The required values at baseline are as follows:
Absolute neutrophil count >1.5 x 109 /L, Platelet count > 100 x 109 /L, Haemoglobin > 9g/dl, total bilirubin < 1.5 upper limit of normal (ULN); AST, ALT<2.5 ULN in patients without liver metastases, <5 ULN in patients with liver metastases; serum creatinine < 2.0 mg/dl, amylase and lipase <1.5 ULN |
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E.4 | Principal exclusion criteria |
1.Prior medical treatment for metastatic RCC (are allowed adjuvant or neo-adjuvant treatment but stopped almost from six months)
2.Major surgical procedure within 28 days prior to study treatment start
3.Evidence of current central nervous system (CNS) metastases or spinal cord compression. Patients must undergo a MRI or CT scan of the brain within 28 days prior to randomisation
4.Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix, meningiomas)
5.Clinically significant cardiovascular disease, for example cerebrovascular accidents (<6 months), myocardial infarction (<6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication
6.Recent (within the 30 days prior to randomisation) treatment with another investigational drug or participation in another investigational study
7.Chronic treatment with corticosteroids (dose >10 mg/day methylprednisolone equivalent) excluding inhaled steroids.
8.History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
9.Prior isotope treatment
10.PT or INR and PTT <1.5 times the Upper Normal Limit of the institution (patient who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists).
For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care
11.Previous or concomitant radiotherapy in the site parameter of disease
12.Previous radiotherapy or other locoregional antitumoral treatment performed within 21 days before the study recruitment
13.Uncontrolled hypertension (>= 160 mmHg systolic and/or 90 mmHg diastolic) while receiving chronic medication |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the efficacy of the combination of Sorafenib and Interleukin 2 compared with Sorafenib alone in patients with metastatic renal cell carcinoma based on progression free survival |
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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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
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.8.5 | 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 | 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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |