Sorafenib Long Term Extension Program

Last updated: August 11, 2022
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Neoplasms

Treatment

N/A

Clinical Study ID

NCT00625378
12311
2007-002604-17
  • Ages > 16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients, who are participating in a previous Bayer/Onyx sponsored study that hasreached its endpoint (statistical and regulatory or study end), and who are, in theopinion of the Investigator, expected to continue to have an overall positivebenefit/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 priorto study entry and for the duration of study participation, including the 30 daysperiod after last study drug dosing. The investigator should advise the patient how toachieve an adequate contraception.
  • Women of childbearing potential who have a negative pregnancy test within 7 days ofthe first dose of sorafenib in this long term extension program.
  • Patient is receiving sorafenib (Nexavar) as a monotherapy in their originatingprotocol. Patients who were being treated with sorafenib (Nexavar) in combination withother 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) andcapecitabine in their originating Study 12444 (RESILIENCE) will be eligible.
  • Patients who are receiving concurrent combination with sorafenib (Nexavar) anderlotinib in their originating study 12917 (SEARCH) were eligible.
  • Patients who have completed the End of Treatment assessments in their originatingstudy. Every effort should be made to conduct the End of Treatment visit such that thepatient does not have any interruption of sorafenib dosing.

Exclusion

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 thecancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basalcell carcinoma, superficial bladder tumors ( Ta, Tis &T1) or any cancer curativelytreated > 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 withthe 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 compliancein the study. Excluded therapies and medications, previous and concomitant:
  • Concurrent anti-cancer chemotherapy, except transarterial chemoembolization (TACE) andcapecitabine
  • Concurrent immunotherapy (including monoclonal antibodies), during or within 30 daysprior to start of study drug
  • Concurrent hormonal therapy, except for bisphosphonates,during or within 30 days priorto start of study drug
  • Concomitant Rifampicin and St John's Wort (Warfarin may be used only with very closemonitoring)
  • Radiotherapy during study or within 3 weeks of start of study drug. [Palliativeradiotherapy will be allowed]
  • Concomitant use of potent inhibitors of CYP3A4 including ketoconazole, itraconazoleand ritonavir. Consumption of grapefruit juice should also be avoided.

Study Design

Total Participants: 206
Study Start date:
December 21, 2007
Estimated Completion Date:
September 24, 2021

Connect with a study center

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    Buenos Aires, Ciudad Auton. de Buenos Aires C1280AEB
    Argentina

    Site Not Available

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    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Bruxelles - Brussel, 1200
    Belgium

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  • Charleroi, 6000
    Belgium

    Site Not Available

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    São Paulo, Sao Paulo 01331020
    Brazil

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    São Paulo, Sao Paulo 01331020
    Brazil

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  • Sao Paulo, 01246-903
    Brazil

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  • Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Varna, 9010
    Bulgaria

    Site Not Available

  • Calgary, Alberta T2N 4N1
    Canada

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  • Edmonton, Alberta T6G 1Z2
    Canada

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    Surrey, British Columbia V3V 1Z2
    Canada

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  • Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Montreal, Quebec H3G 1A4
    Canada

    Site Not Available

  • Guangzhou, Guangdong 510080
    China

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  • Xi'an, Shanxi 710032
    China

    Site Not Available

  • Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • Beijing, 100021
    China

    Site Not Available

  • Shanghai, 200030
    China

    Site Not Available

  • Floridablanca, Santander
    Colombia

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    Floridablanca-Bucaramanga, Santander
    Colombia

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  • Bordeaux, 33000
    France

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  • Gauting, Bayern 82131
    Germany

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    München, Bayern 81377
    Germany

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    München, Bayern 81377
    Germany

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  • Regensburg, Bayern 93042
    Germany

    Site Not Available

  • Essen, Nordrhein-Westfalen 45239
    Germany

    Site Not Available

  • Grosshansdorf, Schleswig-Holstein 22927
    Germany

    Site Not Available

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    Großhansdorf, Schleswig-Holstein 22927
    Germany

    Site Not Available

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    Großhansdorf, Schleswig-Holstein 22927
    Germany

    Site Not Available

  • Berlin, 12200
    Germany

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  • Hamburg, 20246
    Germany

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    Athens, Attica 11528
    Greece

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    Larissa, 41111
    Greece

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    Patra, 26500
    Greece

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    Patras, 26500
    Greece

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    Rio / Patra, 26500
    Greece

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  • Hong Kong,
    Hong Kong

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    Beer Sheva, 85025
    Israel

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    Haifa, 31096
    Israel

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    Jerusalem, 91120
    Israel

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    Petach Tikva, 4941492
    Israel

    Site Not Available

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    Petah Tikva, 4941492
    Israel

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  • Bologna, Emilia-Romagna 40138
    Italy

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  • Reggio Emilia, Emilia-Romagna 42123
    Italy

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  • Milano, Lombardia 20089
    Italy

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  • Pavia, Lombardia 27100
    Italy

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    Rozzano, Milano 20089
    Italy

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  • Torino, Piemonte 10043
    Italy

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    Orbassano, Torino 10043
    Italy

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  • Pisa, Toscana 56126
    Italy

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  • Siena, Toscana 53100
    Italy

    Site Not Available

  • Perugia, Umbria 06132
    Italy

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    Campobasso, 00168
    Italy

    Site Not Available

  • Daegu, 700721
    Korea, Republic of

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  • Seoul, 03722
    Korea, Republic of

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  • Auckland, 1023
    New Zealand

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    Wellington South, 6001
    New Zealand

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  • Gdansk, 80-219
    Poland

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    Lublin, 20-090
    Poland

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  • Poznan, 61-848
    Poland

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  • Szczecin, 70-111
    Poland

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  • Warszawa, 04-141
    Poland

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  • Wroclaw, 50 - 556
    Poland

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    Moscow, 115478
    Russian Federation

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    South Africa,
    South Africa

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  • Oviedo, Asturias 33011
    Spain

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    Hospitalet de Llobregat, Barcelona 08907
    Spain

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    Cruces/Barakaldo, Bilbao 48903
    Spain

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  • Alicante, 03010
    Spain

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  • Barcelona, 08035
    Spain

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  • Madrid, 28041
    Spain

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  • Valencia, 46014
    Spain

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    Chia Yi, 613
    Taiwan

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  • Kaohsiung, 833
    Taiwan

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  • Taichung, 40447
    Taiwan

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  • Tainan, 736
    Taiwan

    Site Not Available

  • Taipei, 106
    Taiwan

    Site Not Available

  • Taoyuan, 33305
    Taiwan

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    Donetsk, 83092
    Ukraine

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  • Kiev, 115
    Ukraine

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  • Southampton, Hampshire SO16 6YD
    United Kingdom

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  • Maidstone, Kent ME16 9QQ
    United Kingdom

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  • Cardiff, South Glamorgan CF14 2TL
    United Kingdom

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  • Sutton, Surrey SM2 5PT
    United Kingdom

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  • Glasgow, G12 0YN
    United Kingdom

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  • London, SE1 9RT
    United Kingdom

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  • Los Angeles, California 90025
    United States

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    Aurora, Colorado 80045
    United States

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  • New Haven, Connecticut 06511-5991
    United States

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    Tampa, Florida 33612
    United States

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    Omaha, Nebraska 68114
    United States

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  • Philadelphia, Pennsylvania 19104
    United States

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    Nashville, Tennessee 37203
    United States

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  • San Antonio, Texas 78229
    United States

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    Charlottesville, Virginia 22908
    United States

    Site Not Available

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