Sorafenib Long Term Extension Program

NCT ID: NCT00625378

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-21
• Study Completion Date: 2021-09-24

Brief Summary

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sorafenib (Nexavar, BAY43-9006)

Participants receive single-agent sorafenib at the same dose and schedule as in their original clinical trials.

Group Type: EXPERIMENTAL

Sorafenib (Nexavar, BAY43-9006)

Intervention Type: DRUG

At the same dose and schedule as in the participants' original clinical trials

Interventions

Sorafenib (Nexavar, BAY43-9006)

At the same dose and schedule as in the participants' original clinical trials

Intervention Type: DRUG

Eligibility 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 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ICON Clinical Research

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Los Angeles, California, United States

New Haven, Connecticut, United States

Philadelphia, Pennsylvania, United States

San Antonio, Texas, United States

Randwick, New South Wales, Australia

Bruxelles - Brussel, , Belgium

Charleroi, , Belgium

São Paulo, , Brazil

Plovdiv, , Bulgaria

Varna, , Bulgaria

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Guangzhou, Guangdong, China

Xi’an, Shanxi, China

Hangzhou, Zhejiang, China

Beijing, , China

Shanghai, , China

Floridablanca, Santander Department, Colombia

Bordeaux, , France

Gauting, Bavaria, Germany

Regensburg, Bavaria, Germany

Essen, North Rhine-Westphalia, Germany

Großhansdorf, Schleswig-Holstein, Germany

Berlin, , Germany

Hamburg, , Germany

Hong Kong, , Hong Kong

Bologna, Emilia-Romagna, Italy

Reggio Emilia, Emilia-Romagna, Italy

Milan, Lombardy, Italy

Milan, Lombardy, Italy

Milan, Lombardy, Italy

Pavia, Lombardy, Italy

Turin, Piedmont, Italy

Pisa, Tuscany, Italy

Siena, Tuscany, Italy

Perugia, Umbria, Italy

Auckland, , New Zealand

Gdansk, , Poland

Poznan, , Poland

Szczecin, , Poland

Warsaw, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Seoul, Seoul Teugbyeolsi, South Korea

Daegu, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Oviedo, Principality of Asturias, Spain

Alicante, , Spain

Barcelona, , Spain

Barcelona, , Spain

Barcelona, , Spain

Madrid, , Spain

Madrid, , Spain

Valencia, , Spain

Kaohsiung City, , Taiwan

Taichung, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Kiev, , Ukraine

Southampton, Hampshire, United Kingdom

Maidstone, Kent, United Kingdom

Cardiff, South Glamorgan, United Kingdom

Sutton, Surrey, United Kingdom

Glasgow, , United Kingdom

London, , United Kingdom

London, , United Kingdom

Countries

United States; Australia; Belgium; Brazil; Bulgaria; Canada; China; Colombia; France; Germany; Hong Kong; Italy; New Zealand; Poland; South Korea; Spain; Taiwan; Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

2007-002604-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12311

Identifier Type: -

Identifier Source: org_study_id