check_circleStudy Completed
Neoplasms
Bayer Identifier:
12311
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Sorafenib Long Term Extension Program
Trial purpose
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.
An additional objective was the assessment of the safety of Nexavar or Nexavar combination treatment.
Key Participants Requirements
Sex
BothAge
16 - N/ATrial summary
Enrollment Goal
206Trial Dates
December 2007 - September 2021Phase
Phase 3Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Essen, 45239, Germany | |
Completed | Southampton, SO16 6YD, United Kingdom | |
Completed | Maidstone, ME16 9QQ, United Kingdom | |
Completed | London, SE1 9RT, United Kingdom | |
Completed | Glasgow, G12 0YN, United Kingdom | |
Completed | Sutton, SM2 5PT, United Kingdom | |
Withdrawn | Charlottesville, 22908, United States | |
Completed | San Antonio, 78229, United States | |
Completed | New Haven, 06511-5991, United States | |
Withdrawn | Tampa, 33612, United States | |
Withdrawn | Philadelphia, 19111-2497, United States | |
Completed | Warszawa, 02-781, Poland | |
Completed | Wroclaw, 50 - 556, Poland | |
Completed | Szczecin, 70-111, Poland | |
Completed | Hamburg, 20246, Germany | |
Completed | Berlin, 12200, Germany | |
Completed | Regensburg, 93042, Germany | |
Withdrawn | München, 81377, Germany | |
Completed | Grosshansdorf, 22927, Germany | |
Completed | London, SW3 6JJ, United Kingdom | |
Withdrawn | Nashville, 37203, United States | |
Completed | Los Angeles, 90025, United States | |
Completed | Philadelphia, 19104, United States | |
Withdrawn | Omaha, 68114, United States | |
Completed | Bologna, 40138, Italy | |
Completed | Milano, 20089, Italy | |
Completed | Gdansk, 80-219, Poland | |
Completed | Warszawa, 04-141, Poland | |
Completed | Poznan, 61-848, Poland | |
Completed | Warszawa, 02-781, Poland | |
Withdrawn | Lublin, 20-090, Poland | |
Completed | Bologna, 40138, Italy | |
Completed | Pisa, 56126, Italy | |
Completed | Reggio Emilia, 42123, Italy | |
Completed | Torino, 10043, Italy | |
Completed | Barcelona, 08036, Spain | |
Completed | Valencia, 46014, Spain | |
Completed | Barcelona, 08003, Spain | |
Completed | Barcelona, 08035, Spain | |
Completed | Calgary, T2N 4N1, Canada | |
Completed | Pavia, 27100, Italy | |
Completed | Milano, 20133, Italy | |
Completed | Perugia, 06132, Italy | |
Withdrawn | Barakaldo, 48903, Spain | |
Completed | Alicante, 03010, Spain | |
Completed | Oviedo, 33011, Spain | |
Completed | Madrid, 28040, Spain | |
Completed | Montreal, H3A 1A1, Canada | |
Completed | Toronto, M5G 2C4, Canada | |
Completed | Montreal, H3T 1E2, Canada | |
Completed | BRUXELLES - BRUSSEL, 1200, Belgium | |
Completed | CHARLEROI, 6000, Belgium | |
Withdrawn | São Paulo, 01331020, Brazil | |
Withdrawn | Moscow, 115552, Russian Federation | |
Completed | Toronto, M5G 2M9, Canada | |
Withdrawn | Camperdown, 2050, Australia | |
Completed | Randwick, 2031, Australia | |
Completed | Sao Paulo, 01246-903, Brazil | |
Withdrawn | Donetsk, 83092, Ukraine | |
Completed | Kiev, 115, Ukraine | |
Completed | Seoul, 06351, Korea, Republic Of | |
Completed | Seoul, 03722, Korea, Republic Of | |
Completed | Seoul, 03080, Korea, Republic Of | |
Completed | Taipei, 10002, Taiwan | |
Completed | Daegu, 700721, Korea, Republic Of | |
Completed | BORDEAUX, 33000, France | |
Completed | Edmonton, T6G 1Z2, Canada | |
Withdrawn | Petah Tikva, 4941492, Israel | |
Completed | Beijing, 100021, China | |
Completed | Xi'an, 710032, China | |
Completed | Auckland, 1023, New Zealand | |
Completed | Cardiff, CF14 2TL, United Kingdom | |
Completed | Madrid, 28041, Spain | |
Completed | Milano, 20122, Italy | |
Withdrawn | Campobasso, 00168, Italy | |
Withdrawn | Barcelona, 08036, Spain | |
Withdrawn | Hospitalet de Llobregat, 08907, Spain | |
Completed | Gauting, 82131, Germany | |
Completed | Hong Kong, Hong Kong | |
Completed | Seoul, 06351, Korea, Republic Of | |
Completed | Glasgow, G12 0YN, United Kingdom | |
Completed | Montreal, H3G 1A4, Canada | |
Completed | Floridablanca, Colombia | |
Completed | Guangzhou, 510080, China | |
Withdrawn | Taipei, 100, Taiwan | |
Completed | Taoyuan, 33305, Taiwan | |
Completed | Taipei, 106, Taiwan | |
Completed | Taichung, 40447, Taiwan | |
Withdrawn | Chia Yi, 613, Taiwan | |
Completed | Kaohsiung, 833, Taiwan | |
Completed | Tainan, 736, Taiwan | |
Completed | Plovdiv, 4002, Bulgaria | |
Completed | Varna, 9010, Bulgaria | |
Withdrawn | Beer Sheva, 8410101, Israel | |
Withdrawn | Haifa, 3109601, Israel | |
Withdrawn | Jerusalem, 9112001, Israel | |
Withdrawn | Athens, 11528, Greece | |
Withdrawn | Patras, 26500, Greece | |
Withdrawn | Larissa, 41100, Greece | |
Completed | Shanghai, 200030, China | |
Withdrawn | Seoul, 05505, Korea, Republic Of | |
Withdrawn | Seoul, 06351, Korea, Republic Of | |
Withdrawn | Shanghai, 200032, China | |
Completed | Warszawa, 04-141, Poland | |
Completed | Siena, 53100, Italy | |
Completed | Pisa, 56126, Italy | |
Completed | Warszawa, 02-781, Poland | |
Completed | Beijing, 100021, China | |
Completed | Hangzhou, 310022, China |
Primary Outcome
- Sorafenib treatment duration within STEPTreatment 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.date_rangeTime Frame: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
- Number of participants with new treatment-emergent adverse events (TEAEs)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.date_rangeTime Frame:From signing the informed consent form (ICF) in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
- Number of participants with new TEAEs of CTCAE grades 3 or higher by worst CTCAE gradeAn 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.date_rangeTime Frame:From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
- Number of participants with study drug-related new TEAEs of CTCAE grades 3 or higher by worst CTCAE gradeAn 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.date_rangeTime Frame:From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
- Number of participants with all adverse eventsAn 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.date_rangeTime Frame:From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
- Number of participants with all adverse events of CTCAE grades 3 or higher by worst CTCAE gradeAn 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.date_rangeTime Frame:From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
- Number of participants with study drug-related all adverse events of CTCAE grades 3 or higher by worst CTCAEAn 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.date_rangeTime Frame:From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
- Number of deaths with primary cause of deathPrimary 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.date_rangeTime Frame:From signing the ICF in STEP until completion or discontinuation of the study, with a mean duration of 26 months
- Number of participants with abnormal hematological and biochemical laboratory values by worst CTCAE gradeHematology 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.date_rangeTime Frame:From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
- Number of participants with ECOG performance status by 6-months time intervalsEastern 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 = Deaddate_rangeTime Frame:Up to 156 months
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1