Sorafenib Long Term Extension Program (STEP)

Tracking Information

Start Date  ICMJEDecember 2007
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 20, 2008)
Long term safety of patients coming from completed sorafenib trials. [ Time Frame: 2012 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00625378 on Archive Site

Descriptive Information

Brief Title  ICMJESorafenib Long Term Extension Program (STEP)
Official Title  ICMJESorafenib Long Term Extension Program
Brief Summary

This study is focusing on patients with cancer who are currently enrolled in a Bayer/Onyx sponsored clinical trial and receive sorafenib as monotherapy. During the entire course of the study, which is about 5 years, numerous patients will be treated with sorafenib. Involvement in this study will be depending on whether the patient benefits from the treatment or not, based on the physician's judgment and the results of particular additional examinations. Overall, participation in this study will help to evaluate the safety of treatment with sorafenib.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Condition  ICMJENeoplasms
Intervention  ICMJEDrug: Sorafenib (Nexavar, BAY43-9006)
All patients are treated with sorafenib according to the dosage scheme of their previous trial. (400 - 600 bid)
Study Arms / Comparison GroupsArm 1: Experimental
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)

Recruitment Information

Estimated Enrollment  ICMJE2000
Estimated Completion DateAugust 2010
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • 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.

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

Excluded therapies and medications, previous and concomitant:

  • Concurrent anti-cancer chemotherapy, immunotherapy (including monoclonal antibodies) or 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 CYP 3A4 including ketoconazole, itraconazole and ritonavir. Consumption of grapefruit juice should also be avoided.
Ages16 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Bayer Clinical Trials
Contact: For trial location information (Phone Menu Options '3' or '4')(+)1-888-84 22937
Location Countries  ICMJEUnited States,   Australia,   Belgium,   Brazil,   Canada,   Germany,   Italy,   New Zealand,   Poland,   Russian Federation,   Spain,   Taiwan,   Ukraine,   United Kingdom

Administrative Information

Responsible PartyTherapeutic Area Head, Bayer HealthCare AG
Study ID Numbers  ICMJE12311, EudraCT: 2007-002604-17, STEP
Study Sponsor  ICMJEBayer
Collaborators  ICMJEICON Clinical Research
Investigators  ICMJE
Study Director:Bayer Study DirectorBayer
Information Provided ByBayer