Sorafenib Long Term Extension Program (STEP)

• Register: EUCTR
• Last refreshed on: 3 November 2021
• Main ID: EUCTR2007-002604-17-BE
• Date of registration: 18/09/2008
• Prospective Registration: Yes
• Primary sponsor: Bayer AG, D-51368 Leverkusen, Germany
• Public title: Sorafenib Long Term Extension Program (STEP)
• Scientific title: Sorafenib Long Term Extension Program (STEP) - STEP
• Date of first enrolment: 03/10/2008
• Target sample size: 2000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002604-17
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Hungary, Israel, Italy, Japan, New Zealand, Poland, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer AG

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer AG

Key inclusion & exclusion criteria

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) Patient who are receiving concurrent combination with sorafenib (Nexavar) and TACE (transarterial chemoembolization) in their originating study will be eligible.
7)Patients who are receiving concurrent combination with sorafenib (Nexavar) and erlotinib in their originating study 12917 (SEARCH) will be eligible.
8) Patients who are receiving concurrent combination with sorafenib (Nexavar) and capecitabine in their originating study 12444 (RESILIENCE) will be eligible.
9)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:
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
9) Concurrent anti-cancer chemotherapy, except TACE (transarterial chemoembolization), erlotinib, and capecitabine
10) Concurrent immunotherapy (including monoclonal antibodies), during or within 30 days prior to start of study drug
11) Concurrent hormonal therapy, except for bisphosphonates, during or within 30 days prior to start of study drug
12) Concomitant Rifampicin and St John’s Wort (Warfarin may be used only with very close monitoring).
13) Radiotherapy during study or within 3 weeks of start of study drug. [Palliative radiotherapy will be allowed as described in the Prior and Concomitant Therapy Section 4.5.8. of the protocol]
14) Concomitant use of potent inhibitors of CYP 3A4 including ketoconazole, itraconazole and ritonavir. Consumption of grapefruit juice should also be avoided.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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: 21.1 Level: PT Classification code 10028980 Term: Neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: NEXAVAR
Product Name: sorafenib
Product Code: BAY 43-9006
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sorafenib
CAS Number: 284461-74-0
Current Sponsor code: BAY 43-9006
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

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.

Primary end point(s): Not applicable

Secondary Objective: Not applicable

Secondary ID(s)

2007-002604-17-FR

BAY43-9006/12311

Source(s) of Monetary Support

Bayer AG

Ethics review

Status: Approved
Approval date: 03/10/2008
Contact: