Clinical trial NCT00625378: Sorafenib Long Term Extension Program
Official title: Sorafenib Long Term Extension Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neoplasms
Keywords: Cancer
Sorafenib
Extension program
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: ICON Clinical Research
First posted: 2008-02-28
Enrollment: 206
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Sorafenib Treatment Duration Within STEP
timeFrame: From the date of the first sorafenib dose until the date of the last sorafenib dose, with a mean duration of 25 months and max duraton of 153.8 months
measure: Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
timeFrame: From signing the informed consent form (ICF) in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
measure: Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade
timeFrame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
measure: Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade
timeFrame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
measure: Number of Participants With All Adverse Events
timeFrame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
measure: Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade
timeFrame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
measure: Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE
timeFrame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
measure: Number of Deaths With Primary Cause of Death
timeFrame: From signing the ICF in STEP until completion or discontinuation of the study, with a mean duration of 26 months
measure: Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
timeFrame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
measure: Number of Participants With ECOG Performance Status by 6-months Time Intervals
timeFrame: Up to 156 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Philadelphia
country: United States
state: Pennsylvania
city: San Antonio
country: United States
state: Texas
city: Randwick
country: Australia
state: New South Wales
city: Bruxelles - Brussel
country: Belgium
city: Charleroi
country: Belgium
city: Sao Paulo
country: Brazil
city: Plovdiv
country: Bulgaria
city: Varna
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Guangzhou
country: China
state: Guangdong
city: Xi'an
country: China
state: Shanxi
city: Hangzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Shanghai
country: China
city: Floridablanca
country: Colombia
state: Santander
city: Bordeaux
country: France
city: Gauting
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Grosshansdorf
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hong Kong
country: Hong Kong
city: Bologna
country: Italy
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
state: Emilia-Romagna
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Torino
country: Italy
state: Piemonte
city: Pisa
country: Italy
state: Toscana
city: Siena
country: Italy
state: Toscana
city: Perugia
country: Italy
state: Umbria
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Daegu
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Auckland
country: New Zealand
city: Gdansk
country: Poland
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Oviedo
country: Spain
state: Asturias
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Kiev
country: Ukraine
city: Southampton
country: United Kingdom
state: Hampshire
city: Maidstone
country: United Kingdom
state: Kent
city: Cardiff
country: United Kingdom
state: South Glamorgan
city: Sutton
country: United Kingdom
state: Surrey
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: