E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced Renal Cell Carcinoma |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study is to make BAY 43-9006 available for patients with advanced RCC, who failed prior systemic therapy for advanced disease (i. e., require second line treatment), and who do not have access to or are not eligible for other clinical trials with BAY 43-9006. |
|
E.2.2 | Secondary objectives of the trial |
In addition, safety data and limited efficacy data will be collected for BAY 43-9006 in the treatment of patients with advanced RCC, who failed prior systemic therapy for advanced disease (i. e., require second line treatment). All Drug Related Adverse Events, all Adverse Events NCI CTCAE Version 3.0 Grade 3 or higher, and all Serious Adverse Events regardless of causal relationship to study drug will be recorded in this study. It is expected that, according to the oncological standards, radiological and other procedures will have been performed prior to enrolment of any patient, and, similarly, that the Investigator will be performing appropriate radiological and other procedures according to the local standard of care, although these procedures are not specifically defined within this study protocol. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.The patient must provide written informed consent prior to receiving BAY 43-9006. 2.The male or female patient must be at least 18 years of age. 3.The patient must have advanced Renal Cell Carcinoma. 4.The patient must have failed at least one prior systemic established therapy for advanced RCC (e. g., IL-2, IFN-alpha), or must have been unable to tolerate systemic therapy for advanced RCC, or is deemed by the Investigator to be unsuited for systemic therapy for advanced RCC. 5.A patient, who has received prior systemic and local therapies, must have completely recovered from acute toxicity (i. e., resolved back to CTCAE Grade 1 or less, or is considered as not going to resolve), if any, prior to study entry. 6.The patient must be, in the Investigator’s opinion, reasonably likely to benefit from treatment with BAY 43-9006 as a single agent. 7.The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 8.The patient will not require other systemic anti-cancer chemotherapy, immunotherapy (including monoclonal antibodies) or hormonal therapy, except for bisphosphonates while taking BAY 43-9006. 9.Both male and female patients must use adequate barrier birth control methods (oral contraceptives, injectable contraceptives, intrauterine devices, condoms, sterilization) during their participation in the protocol. The birth control methods must be used for 4 weeks for female patients and for 3 months for male patients after discontinuation of treatment with BAY 43-9006. 10.For patients, who have had major surgery, the wound must be completely healed prior to receiving BAY 43-9006 treatment (4 weeks).
|
|
E.4 | Principal exclusion criteria |
1.Patients who are currently enrolled in or have previously participated in any other BAY 43-9006 trial. 2.Patients, who are eligible for or do have access to any other BAY 43-9006 clinical trial as to the knowledge of the Investigator. 3.Patients who have a life expectancy of less than 2 months. 4.Patients with metastatic brain or meningeal tumours. 5.Patients are excluded who require any of the following: a.Investigational drug therapy during the treatment with BAY 43-9006 or within 30 days prior to their first dose of BAY 43-9006. b.Concomitant Rifampicin. c.Concomitant St. John’s Wort (Hypericum perforatum). Warfarin is allowed; however, for patients receiving concomitant warfarin therapy close monitoring of Prothrombin Time (PT) should be performed (please note that no laboratory data are collected in this study). 6.Women who are pregnant or breast feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of study drug (please note that no laboratory data are collected in this study). 7.Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity) 8.Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTc > 0.45 - 0.47 second). 9.Patients with active coronary artery disease or ischemia. 10.Patients with Child Pugh class C hepatic impairment. 11.Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis. 12.Patients with active uncontrolled hypertension. 13.Patients with recent or active bleeding diathesis. 14.Patients with any medical condition which could jeopardize their safety while taking an investigational drug.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
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 | 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 | 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 | No |
E.8.1.1 | Randomised | No |
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) | No |
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 | Yes |
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
|
It is the intention of the Sponsor to continue the protocol until BAY 43-9006 is approved by the EMEA, i. e. the recruitment of patients will be stopped after approval of the study drug. The protocol may be discontinued at any time if, for example, data become available from ongoing clinical trials which changes the risk/benefit assessment. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 15 |