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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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30 November 2020 |
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Main ID: |
EUCTR2007-002604-17-IT |
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Date of registration:
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11/12/2007 |
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Prospective Registration:
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No |
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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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30/11/2007 |
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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: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: conferma terapeutica
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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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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Poland
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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:
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.
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:
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 patient?s 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.
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 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.
MedDRA version: 9.1
Level: HLGT
Classification code 10027655
Term: Miscellaneous and site unspecified neoplasms malignant and unspecified
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Intervention(s)
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Trade Name: NEXAVAR
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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Secondary Objective:
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Main Objective: 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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Primary end point(s):
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Secondary ID(s)
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2007-002604-17-FR
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12311
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 11/10/2007
Contact:
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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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URL:
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