E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Various Cancer indication/types (e.g. Renal Cell Carcinoma, Hepatoma Carcinoma, Melanoma and other cancer types). Patients who remain actively treated in a Bayer/Onyx sponsored Clinical Trial that has reached its statistical, regulatory and/or study end and who, in the opinion of the Investigator, still benefiting from treatment, will be eligible for entry into this program. |
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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 | HLGT |
E.1.2 | Classification code | 10027655 |
E.1.2 | Term | Miscellaneous and site unspecified neoplasms malignant and unspecified |
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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 purpose of this program is to enable patients, currently receiving single agent sorafenib in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study has met its primary endpoint and/or has reached the end as defined in the original protocol. Patients will be able to continue sorafenib treatment until the treating physician feels the patient is no longer benefiting from the treatment or sorafenib becomes commercially available, and reimbursed for the respective indication as applicable in the country in which the patient lives. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients, who are participating in a previous Bayer/Onyx sponsored study that has reached its endpoint (statistical and regulatory or study end), and who are, in the opinion of the Investigator, expected to continue to have an overall positive benefit/risk from continuing treatment. Patients who have signed informed consent for this long term extension program. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing. The investigator should advise the patient how to achieve an adequate contraception. Women of childbearing potential who have a negative pregnancy test within 7 days of the first dose of sorafenib in this long term extension program. Patient is receiving sorafenib as a monotherapy in their originating protocol. Patients who were being treated with sorafenib in combination with other chemotherapies in the original study, but continued on single agent sorafenib after discontinuation of the combination agent will be eligible. Patients who have completed the End of Treatment assessments in their originating study. Every effort should e made to conduct the End of Treatment visit such that the patient does not have any interruption in sorafenib dosing. |
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E.4 | Principal exclusion criteria |
Any condition that is unstable or which could jeopardize the safety of the patient (please refer to the Investigator Brochure and product labeling safety sections). History of cardiac disease: congestive heart failure>NYHA Class 2 or uncontrolled hypertension. Myocardial infarction (MI) within the last 3 months. Symptomatic metastatic brain or meningeal tumors. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors ( Ta, Tis &T1) or any cancer curatively treated > 5 years prior to study entry. Patients with seizure disorder requiring medication (such as steroid anti-epileptics). Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results. Any condition which could jeopardise the safety of the patient and his/her compliance in the study. |
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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 | No |
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) | 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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
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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.8.5 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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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 | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |