Trial Condition(s):

Neoplasms

Sorafenib Long Term Extension Program (STEP)

Bayer Identifier:

12311

ClinicalTrials.gov Identifier:

NCT00625378

EudraCT Number:

2007-002604-17

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
206
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Essen, Germany, 45239

Status
Completed
 
Locations

Investigative Site

Southampton, United Kingdom, SO16 6YD

Status
Completed
 
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Investigative Site

Maidstone, United Kingdom, ME16 9QQ

Status
Completed
 
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Investigative Site

London, United Kingdom, SE1 9RT

Status
Completed
 
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Investigative Site

Glasgow, United Kingdom, G12 0YN

Status
Completed
 
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Investigative Site

Sutton, United Kingdom, SM2 5PT

Status
Completed
 
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Investigative Site

San Antonio, United States, 78229

Status
Completed
 
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Investigative Site

New Haven, United States, 06511-5991

Status
Completed
 
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Investigative Site

Warszawa, Poland, 02-781

Status
Completed
 
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Investigative Site

Wroclaw, Poland, 50 - 556

Status
Completed
 
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Investigative Site

Szczecin, Poland, 70-111

Status
Completed
 
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Investigative Site

Hamburg, Germany, 20246

Status
Completed
 
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Investigative Site

Berlin, Germany, 12200

Status
Completed
 
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Investigative Site

Regensburg, Germany, 93042

Status
Completed
 
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Investigative Site

Grosshansdorf, Germany, 22927

Status
Completed
 
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Investigative Site

London, United Kingdom, SW3 6JJ

Status
Completed
 
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Investigative Site

Los Angeles, United States, 90025

Status
Completed
 
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Investigative Site

Philadelphia, United States, 19104

Status
Completed
 
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Investigative Site

Bologna, Italy, 40138

Status
Completed
 
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Investigative Site

Milano, Italy, 20089

Status
Completed
 
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Investigative Site

Gdansk, Poland, 80-219

Status
Completed
 
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Investigative Site

Warszawa, Poland, 04-141

Status
Completed
 
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Poznan, Poland, 61-848

Status
Completed
 
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Investigative Site

Pisa, Italy, 56126

Status
Completed
 
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Reggio Emilia, Italy, 42123

Status
Completed
 
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Investigative Site

Torino, Italy, 10043

Status
Completed
 
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Barcelona, Spain, 08036

Status
Completed
 
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Valencia, Spain, 46014

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08003

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
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Investigative Site

Calgary, Canada, T2N 4N1

Status
Completed
 
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Investigative Site

Pavia, Italy, 27100

Status
Completed
 
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Investigative Site

Milano, Italy, 20133

Status
Completed
 
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Investigative Site

Perugia, Italy, 06132

Status
Completed
 
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Investigative Site

Alicante, Spain, 03010

Status
Completed
 
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Investigative Site

Oviedo, Spain, 33011

Status
Completed
 
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Investigative Site

Madrid, Spain, 28040

Status
Completed
 
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Investigative Site

Montreal, Canada, H3A 1A1

Status
Completed
 
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Investigative Site

Toronto, Canada, M5G 2C4

Status
Completed
 
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Investigative Site

Montreal, Canada, H3T 1E2

Status
Completed
 
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Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
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Investigative Site

CHARLEROI, Belgium, 6000

Status
Completed
 
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Investigative Site

Toronto, Canada, M5G 2M9

Status
Completed
 
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Investigative Site

Randwick, Australia, 2031

Status
Completed
 
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Investigative Site

Sao Paulo, Brazil, 01246-903

Status
Completed
 
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Investigative Site

Kiev, Ukraine, 115

Status
Completed
 
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Investigative Site

Seoul, South Korea, 06351

Status
Completed
 
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Investigative Site

Seoul, South Korea, 03722

Status
Completed
 
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Investigative Site

Seoul, South Korea, 03080

Status
Completed
 
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Investigative Site

Taipei, Taiwan, China, 10002

Status
Completed
 
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Investigative Site

Daegu, South Korea, 700721

Status
Completed
 
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Investigative Site

BORDEAUX, France, 33000

Status
Completed
 
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Investigative Site

Edmonton, Canada, T6G 1Z2

Status
Completed
 
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Investigative Site

Beijing, China, 100021

Status
Completed
 
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Investigative Site

Xi'an, China, 710032

Status
Completed
 
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Investigative Site

Auckland, New Zealand, 1023

Status
Completed
 
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Investigative Site

Cardiff, United Kingdom, CF14 2TL

Status
Completed
 
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Investigative Site

Madrid, Spain, 28041

Status
Completed
 
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Investigative Site

Milano, Italy, 20122

Status
Completed
 
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Investigative Site

Gauting, Germany, 82131

Status
Completed
 
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Investigative Site

Hong Kong, Hong Kong, China

Status
Completed
 
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Investigative Site

Montreal, Canada, H3G 1A4

Status
Completed
 
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Investigative Site

Floridablanca, Colombia

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510080

Status
Completed
 
Locations

Investigative Site

Taoyuan, Taiwan, China, 33305

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 106

Status
Completed
 
Locations

Investigative Site

Taichung, Taiwan, China, 40447

Status
Completed
 
Locations

Investigative Site

Kaohsiung, Taiwan, China, 833

Status
Completed
 
Locations

Investigative Site

Tainan, Taiwan, China, 736

Status
Completed
 
Locations

Investigative Site

Plovdiv, Bulgaria, 4002

Status
Completed
 
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Investigative Site

Varna, Bulgaria, 9010

Status
Completed
 
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Investigative Site

Shanghai, China, 200030

Status
Completed
 
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Investigative Site

Siena, Italy, 53100

Status
Completed
 
Locations

Investigative Site

Hangzhou, China, 310022

Status
Completed
 

Trial Design