Sorafenib Long Term Extension Program (STEP)

Bayer

Status and phase

Completed

Phase 3

Conditions

Neoplasms

Treatments

Drug: Sorafenib (Nexavar, BAY43-9006)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00625378

2007-002604-17 (EudraCT Number)

12311

Details and patient eligibility

About

The primary purpose of program was to enable patients, currently receiving sorafenib (Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study had met its primary endpoint and/or had reached the end as defined in the original protocol. Patients were able to continue treatment until (i) the treating physician felt the patient was no longer benefiting from the treatment or (ii) the treatment becomes commercially available and reimbursed for the respective indication as applicable in the country in which the patient lived and the patient could obtain suitable amounts of drug for treatment through standard mechanisms of commercial availability (ie, there should be no interruption in the patient's treatment schedule when switching to commercially available product) or (iii) the patient could join a Post-Trial-Access Program, another study or can receive sorafenib through any other mechanism (e.g. local access program) in accordance with local legal and compliance rules, with no cost to the patient with respect to sorafenib.

An additional objective was the assessment of the safety of Nexavar or Nexavar combination treatment.

Enrollment

206 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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 (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.
Patient who are receiving concurrent combination with sorafenib (Nexavar) and TACE (transarterial chemoembolization) in their originating study will be eligible.
Patients who are receiving concurrent combination with sorafenib (Nexavar) and capecitabine in their originating Study 12444 (RESILIENCE) will be eligible.
Patients who are receiving concurrent combination with sorafenib (Nexavar) and erlotinib in their originating study 12917 (SEARCH) were eligible.
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 of sorafenib dosing.

Exclusion criteria

Any condition that is unstable or that 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 > New York Heart Association (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.

Excluded therapies and medications, previous and concomitant:

Concurrent anti-cancer chemotherapy, except transarterial chemoembolization (TACE) and capecitabine
Concurrent immunotherapy (including monoclonal antibodies), during or within 30 days prior to start of study drug
Concurrent hormonal therapy, except for bisphosphonates,during or within 30 days prior to start of study drug
Concomitant Rifampicin and St John's Wort (Warfarin may be used only with very close monitoring)
Radiotherapy during study or within 3 weeks of start of study drug. [Palliative radiotherapy will be allowed]
Concomitant use of potent inhibitors of CYP3A4 including ketoconazole, itraconazole and ritonavir. Consumption of grapefruit juice should also be avoided.