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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00625378
Registration number
NCT00625378
Ethics application status
Date submitted
20/02/2008
Date registered
28/02/2008
Date last updated
1/09/2022
Titles & IDs
Public title
Sorafenib Long Term Extension Program
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Scientific title
Sorafenib Long Term Extension Program
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Secondary ID [1]
0
0
2007-002604-17
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Secondary ID [2]
0
0
12311
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Universal Trial Number (UTN)
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Trial acronym
STEP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms
0
0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
0
Sorafenib Treatment Duration Within STEP
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Assessment method [1]
0
0
Treatment duration was calculated in days as the date of the last dose of any study treatment minus date of the first dose of any study treatment plus one day.
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Timepoint [1]
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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
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Primary outcome [2]
0
0
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
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Assessment method [2]
0
0
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The adverse event did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly or birth defect; was an important medical event. A new treatment-emergent adverse event (TEAE) was any AE that had a start date on or after ICF date in STEP and up to 30 days after the last sorafenib dose. A drug-related new TEAE was any new TEAE that had a causal relationship with the study treatment as assessed by the investigator.
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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
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Primary outcome [3]
0
0
Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade
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Assessment method [3]
0
0
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A new treatment-emergent adverse event (TEAE) was any AE that had a start date on or after ICF date in STEP and up to 30 days after the last sorafenib dose. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria, Version 3.0 (NCI-CTC v. 3.0). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.
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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
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Primary outcome [4]
0
0
Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade
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Assessment method [4]
0
0
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A new treatment-emergent AE (TEAE) was any AE that had a start date on or after ICF date in STEP and up to 30 days after the last sorafenib dose. A drug-related new TEAE was a new TEAE that had a causal relationship with the study treatment as assessed by the investigator. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria (CTC v3). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. The general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.
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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
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Primary outcome [5]
0
0
Number of Participants With All Adverse Events
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Assessment method [5]
0
0
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A drug-related AE was any AE that had a causal relationship with the study treatment as assessed by the investigator. All AEs in STEP were the combination of AEs ongoing from feeder studies and new TEAEs.
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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
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Primary outcome [6]
0
0
Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade
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Assessment method [6]
0
0
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. All AEs in STEP were the combination of AEs ongoing from feeder studies and new TEAEs. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria, Version 3.0 (NCI-CTC v. 3.0). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.
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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
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Primary outcome [7]
0
0
Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE
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Assessment method [7]
0
0
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A drug-related AE was any AE that had a causal relationship with the study treatment as assessed by the investigator. All AEs in STEP was a combination of AEs ongoing from feeder studies and new TEAEs. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria, Version 3.0 (NCI-CTC v. 3.0). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.
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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
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Primary outcome [8]
0
0
Number of Deaths With Primary Cause of Death
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Assessment method [8]
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Primary cause of death included: any cause; progressive disease; toxicity due to study treatment (with at least one AE with outcome death); other (unspecified) or missing cause.
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Timepoint [8]
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0
From signing the ICF in STEP until completion or discontinuation of the study, with a mean duration of 26 months
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Primary outcome [9]
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Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
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Assessment method [9]
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Hematology and blood chemistry values were summarized according to their worst CTCAE grade, where applicable. Hematology and blood chemistry values were graded based on the applicable laboratory threshold values outlined in NCI CTCAE version 3.0. Participants with a specific laboratory value that were "not graded" are not included in the table. CTCAE grade was set to "not graded" if the reference ranges or other information necessary to derive grades were unavailable or result had a special character (such as > or < ). The Common Terminology Criteria for Adverse Events (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.
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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
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Primary outcome [10]
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Number of Participants With ECOG Performance Status by 6-months Time Intervals
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Assessment method [10]
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Eastern cooperative oncology group (ECOG) performance status: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5 = Dead
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Timepoint [10]
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Up to 156 months
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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.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/12/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/09/2021
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Sample size
Target
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Accrual to date
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Final
206
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
0
0
- Randwick
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Recruitment postcode(s) [1]
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0
2031 - Randwick
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Connecticut
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Pennsylvania
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Texas
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Country [5]
0
0
Belgium
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State/province [5]
0
0
Bruxelles - Brussel
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Country [6]
0
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Belgium
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State/province [6]
0
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Charleroi
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Country [7]
0
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Brazil
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State/province [7]
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Sao Paulo
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Country [8]
0
0
Bulgaria
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State/province [8]
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Plovdiv
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Country [9]
0
0
Bulgaria
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State/province [9]
0
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Varna
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Country [10]
0
0
Canada
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State/province [10]
0
0
Alberta
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Country [11]
0
0
Canada
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State/province [11]
0
0
Ontario
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Country [12]
0
0
Canada
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State/province [12]
0
0
Quebec
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Country [13]
0
0
China
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State/province [13]
0
0
Guangdong
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Country [14]
0
0
China
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State/province [14]
0
0
Shanxi
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Country [15]
0
0
China
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State/province [15]
0
0
Zhejiang
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Country [16]
0
0
China
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State/province [16]
0
0
Beijing
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Country [17]
0
0
China
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State/province [17]
0
0
Shanghai
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Country [18]
0
0
Colombia
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State/province [18]
0
0
Santander
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Country [19]
0
0
France
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State/province [19]
0
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Bordeaux
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Country [20]
0
0
Germany
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State/province [20]
0
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Bayern
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0
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Germany
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State/province [21]
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Nordrhein-Westfalen
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Country [22]
0
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Germany
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State/province [22]
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Schleswig-Holstein
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Country [23]
0
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Germany
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State/province [23]
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Berlin
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Country [24]
0
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Germany
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State/province [24]
0
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Hamburg
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Country [25]
0
0
Hong Kong
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State/province [25]
0
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Hong Kong
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Country [26]
0
0
Italy
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State/province [26]
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Emilia-Romagna
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Country [27]
0
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Italy
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State/province [27]
0
0
Lombardia
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Country [28]
0
0
Italy
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State/province [28]
0
0
Piemonte
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Country [29]
0
0
Italy
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State/province [29]
0
0
Toscana
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Country [30]
0
0
Italy
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State/province [30]
0
0
Umbria
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Country [31]
0
0
Korea, Republic of
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State/province [31]
0
0
Seoul Teugbyeolsi
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Country [32]
0
0
Korea, Republic of
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State/province [32]
0
0
Daegu
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Country [33]
0
0
Korea, Republic of
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State/province [33]
0
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Seoul
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Country [34]
0
0
New Zealand
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State/province [34]
0
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Auckland
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Country [35]
0
0
Poland
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State/province [35]
0
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Gdansk
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Country [36]
0
0
Poland
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State/province [36]
0
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Poznan
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Country [37]
0
0
Poland
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State/province [37]
0
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Szczecin
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0
0
Poland
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State/province [38]
0
0
Warszawa
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Country [39]
0
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Poland
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State/province [39]
0
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Wroclaw
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Country [40]
0
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Spain
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State/province [40]
0
0
Asturias
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Country [41]
0
0
Spain
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State/province [41]
0
0
Alicante
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Country [42]
0
0
Spain
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State/province [42]
0
0
Barcelona
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Country [43]
0
0
Spain
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State/province [43]
0
0
Madrid
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Country [44]
0
0
Spain
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State/province [44]
0
0
Valencia
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Country [45]
0
0
Taiwan
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State/province [45]
0
0
Kaohsiung
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0
0
Taiwan
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0
0
Taichung
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0
0
Taiwan
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State/province [47]
0
0
Tainan
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Country [48]
0
0
Taiwan
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State/province [48]
0
0
Taipei
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Country [49]
0
0
Taiwan
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State/province [49]
0
0
Taoyuan
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Country [50]
0
0
Ukraine
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State/province [50]
0
0
Kiev
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Country [51]
0
0
United Kingdom
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State/province [51]
0
0
Hampshire
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Country [52]
0
0
United Kingdom
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State/province [52]
0
0
Kent
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Country [53]
0
0
United Kingdom
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State/province [53]
0
0
South Glamorgan
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Country [54]
0
0
United Kingdom
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State/province [54]
0
0
Surrey
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Country [55]
0
0
United Kingdom
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State/province [55]
0
0
Glasgow
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Country [56]
0
0
United Kingdom
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State/province [56]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
0
0
ICON Clinical Research
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00625378
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Bayer Study Director
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Address
0
0
Bayer
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00625378
Download to PDF