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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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12 October 2015 |
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Main ID: |
EUCTR2007-002604-17-FR |
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Date of registration:
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17/10/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sorafenib Long Term Extension Program (STEP) - STEP
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Scientific title:
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Sorafenib Long Term Extension Program (STEP) - STEP |
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Date of first enrolment:
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14/12/2009 |
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Target sample size:
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2000 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002604-17 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Belgium
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Bulgaria
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France
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Germany
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Italy
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Spain
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1) 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.
2) Patients who have signed informed consent for this long term extension program.
3) 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.
4) 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.
5) Patients receiving sorafenib (Nexavar®) as a monotherapy in their originating protocol. Patients who were being treated with sorafenib (Nexavar®) in combination with other chemotherapies in the original study, but continued on single agent sorafenib (Nexavar®) after discontinuation of the combination agent will be eligible.
6) Patients who have completed the End of Treatment assessments in their originating study. Every effort should be made to conduct the End of Treatment visit such that the patient does not have any interruption in sorafenib dosing.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1) 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).
2) History of cardiac disease: congestive heart failure>NYHA Class 2 (Appendix 10.2) or uncontrolled hypertension
3) Myocardial infarction (MI) within the last 3 months
4) Symptomatic metastatic brain or meningeal tumors
5) 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.
6) Patients with seizure disorder requiring medication (such as steroid anti-epileptics)
7) Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
8) Any condition which could jeopardise the safety of the patient and his/her compliance in the study
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Various cancer indications/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.
MedDRA version: 9.1
Level: LLT
Classification code 10028980
Term: Neoplasm
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Intervention(s)
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Trade Name: NEXAVAR
Product Name: sorafenib
Product Code: BAY 43-9006
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sorafenib
CAS Number: 28844-1-73-1
Current Sponsor code: BAY 43-9006
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
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Primary Outcome(s)
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Primary end point(s): Not applicable
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Main Objective: The purpose of this program is to enable patients, currently receiving single agent sorafenib (Nexavar®) 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 (Nexavar®) treatment until the treating physician feels the patient is no longer benefiting from the treatment or sorafenib (Nexavar®) becomes commercially available, and reimbursed for the respective indication as applicable in the country in which the patient lives or until intolerable/unacceptable toxicity occurs.
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Secondary Objective: Not applicable
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Secondary ID(s)
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BAY 43-9006 / 12311
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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