Sorafenib Long Term Extension Program
Condition: Neoplasms
Intervention: Sorafenib (Nexavar, BAY43-9006)
Intervention description: At the same dose and schedule as in the participants' original clinical trials
Intervention MeSH terms: Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Cancer; Sorafenib; Extension program

Summary:

      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.
    

Eligibility criteria:

        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.