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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00625378




Registration number
NCT00625378
Ethics application status
Date submitted
20/02/2008
Date registered
28/02/2008

Titles & IDs
Public title
Sorafenib Long Term Extension Program
Scientific title
Sorafenib Long Term Extension Program
Secondary ID [1] 0 0
2007-002604-17
Secondary ID [2] 0 0
12311
Universal Trial Number (UTN)
Trial acronym
STEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sorafenib (Nexavar, BAY43-9006)

Experimental: Sorafenib (Nexavar, BAY43-9006) - Participants receive single-agent sorafenib at the same dose and schedule as in their original clinical trials.


Treatment: Drugs: Sorafenib (Nexavar, BAY43-9006)
At the same dose and schedule as in the participants' original clinical trials
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sorafenib Treatment Duration Within STEP
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
From signing the informed consent form (ICF) in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
Primary outcome [3] 0 0
Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade
Timepoint [3] 0 0
From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
Primary outcome [4] 0 0
Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade
Timepoint [4] 0 0
From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
Primary outcome [5] 0 0
Number of Participants With All Adverse Events
Timepoint [5] 0 0
From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
Primary outcome [6] 0 0
Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade
Timepoint [6] 0 0
From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
Primary outcome [7] 0 0
Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE
Timepoint [7] 0 0
From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
Primary outcome [8] 0 0
Number of Deaths With Primary Cause of Death
Timepoint [8] 0 0
From signing the ICF in STEP until completion or discontinuation of the study, with a mean duration of 26 months
Primary outcome [9] 0 0
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Timepoint [9] 0 0
From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
Primary outcome [10] 0 0
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Timepoint [10] 0 0
Up to 156 months

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/09/2021
Sample size
Target
Accrual to date
Final
206
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles - Brussel
Country [6] 0 0
Belgium
State/province [6] 0 0
Charleroi
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Paulo
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Plovdiv
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Varna
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
China
State/province [13] 0 0
Guangdong
Country [14] 0 0
China
State/province [14] 0 0
Shanxi
Country [15] 0 0
China
State/province [15] 0 0
Zhejiang
Country [16] 0 0
China
State/province [16] 0 0
Beijing
Country [17] 0 0
China
State/province [17] 0 0
Shanghai
Country [18] 0 0
Colombia
State/province [18] 0 0
Santander
Country [19] 0 0
France
State/province [19] 0 0
Bordeaux
Country [20] 0 0
Germany
State/province [20] 0 0
Bayern
Country [21] 0 0
Germany
State/province [21] 0 0
Nordrhein-Westfalen
Country [22] 0 0
Germany
State/province [22] 0 0
Schleswig-Holstein
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Hong Kong
Country [26] 0 0
Italy
State/province [26] 0 0
Emilia-Romagna
Country [27] 0 0
Italy
State/province [27] 0 0
Lombardia
Country [28] 0 0
Italy
State/province [28] 0 0
Piemonte
Country [29] 0 0
Italy
State/province [29] 0 0
Toscana
Country [30] 0 0
Italy
State/province [30] 0 0
Umbria
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul Teugbyeolsi
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Daegu
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
New Zealand
State/province [34] 0 0
Auckland
Country [35] 0 0
Poland
State/province [35] 0 0
Gdansk
Country [36] 0 0
Poland
State/province [36] 0 0
Poznan
Country [37] 0 0
Poland
State/province [37] 0 0
Szczecin
Country [38] 0 0
Poland
State/province [38] 0 0
Warszawa
Country [39] 0 0
Poland
State/province [39] 0 0
Wroclaw
Country [40] 0 0
Spain
State/province [40] 0 0
Asturias
Country [41] 0 0
Spain
State/province [41] 0 0
Alicante
Country [42] 0 0
Spain
State/province [42] 0 0
Barcelona
Country [43] 0 0
Spain
State/province [43] 0 0
Madrid
Country [44] 0 0
Spain
State/province [44] 0 0
Valencia
Country [45] 0 0
Taiwan
State/province [45] 0 0
Kaohsiung
Country [46] 0 0
Taiwan
State/province [46] 0 0
Taichung
Country [47] 0 0
Taiwan
State/province [47] 0 0
Tainan
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei
Country [49] 0 0
Taiwan
State/province [49] 0 0
Taoyuan
Country [50] 0 0
Ukraine
State/province [50] 0 0
Kiev
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Hampshire
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Kent
Country [53] 0 0
United Kingdom
State/province [53] 0 0
South Glamorgan
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Surrey
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Glasgow
Country [56] 0 0
United Kingdom
State/province [56] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
ICON Clinical Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00625378