Last updated on February 2008

Sorafenib Long Term Extension Program (STEP)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Neoplasms
  • Age: Between 16 - 100 Years
  • Gender: Male or Female
  • Other:
    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 have completed the End of Treatment assessments in their originating
    tudy. Every effort should e made to conduct the End of Treatment visit such that the
    patient does not have any interruption in sorafenib dosing.

You may not be eligible for this study if the following are true:

  • 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
    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 TACE (transarterial chemoembolization),
    during or within 30 days prior to start of study drug
    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
    Radiotherapy during study or within 3 weeks of start of study drug. [Palliative
    radiotherapy will be allowed]
    Concomitant use of potent inhibitors of CYP 3A4 including ketoconazole, itraconazole
    and ritonavir. Consumption of grapefruit juice should also be avoided.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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