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Sorafenib Long Term Extension Program (STEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00625378
Recruitment Status : Active, not recruiting
First Posted : February 28, 2008
Last Update Posted : August 6, 2019
ICON Clinical Research
Information provided by (Responsible Party):

Brief Summary:

The primary purpose of program is to enable patients, currently receiving 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 treatment until (i) the treating physician feels the patient is no longer benefiting from the treatment or (ii) the treatmenti becomes commercially available and reimbursed for the respective indication as applicable in the country in which the patient lives and the patient can obtain suitable amounts of drug for treatment through standard mechanisms of commercial availability.

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

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Sorafenib (Nexavar, BAY43-9006) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sorafenib Long Term Extension Program
Actual Study Start Date : December 21, 2007
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sorafenib (Nexavar, BAY43-9006)
All patients are treated with sorafenib according to the dosage scheme of their previous trial
Drug: Sorafenib (Nexavar, BAY43-9006)

Primary Outcome Measures :
  1. Long term safety of patients coming from completed sorafenib trials. [ Time Frame: Up to 13 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.
  • Patients who are receiving concurrent combination with sorafenib (Nexavar) and capecitabine in their originating Study 12444 (RESILIENCE) will be eligible.

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, 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00625378

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Sponsors and Collaborators
ICON Clinical Research
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer Identifier: NCT00625378     History of Changes
Other Study ID Numbers: 12311
2007-002604-17 ( EudraCT Number )
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Extension program

Additional relevant MeSH terms:
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Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action