Sorafenib Long Term Extension Program (STEP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bayer
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00625378
First received: February 20, 2008
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

This study will enable patients receiving sorafenib (Nexavar) in the completed Bayer/Onyx sponsored clinical trials to continue treatment. During the entire course of the study, 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 and efficacy of treatment with sorafenib.


Condition Intervention Phase
Neoplasms
Drug: Sorafenib (Nexavar, BAY43-9006)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sorafenib Long Term Extension Program

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Long term safety of patients coming from completed sorafenib trials. [ Time Frame: 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: December 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Sorafenib (Nexavar, BAY43-9006)
All patients are treated with sorafenib according to the dosage scheme of their previous trial.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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, 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625378

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 100 Study Locations
Sponsors and Collaborators
Bayer
ICON Clinical Research
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00625378     History of Changes
Other Study ID Numbers: 12311, 2007-002604-17
Study First Received: February 20, 2008
Last Updated: October 15, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Commission d'Ethique Biomedicale Hospitalo-Facultaire
Brazil: National Health Surveillance Agency
Canada: Health Canada
France: ANSM (National Agency for Drug and health products Safety
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
New Zealand: Medsafe
Poland: Ministry of Health
Spain: Spanish Agency of Medicines
Taiwan : Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Korea: Korea Food and Drug Administration (KFDA)
United States: Food and Drug Administration
China: Food and Drug Administration

Keywords provided by Bayer:
Cancer
Sorafenib
Extension program

Additional relevant MeSH terms:
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014