Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2008-02-29
2011-01-31
Brief Summary
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This is an "open-label" study which means that the patient, the doctor and Bayer Healthcare will know what tablets the patient is taking. All patients in this study will receive sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day). Treatment with sorafenib will continue until the patient's tumor grows larger or spreads further or if the patient has intolerable side effects. The dose of sorafenib that the patient will receive in the study will increase at certain points during the patient's treatment, as long as the patient is not experiencing side effects and the patient's tumor has not grown.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sorafenib (Nexavar, BAY43-9006)
Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
Sorafenib (Nexavar, BAY43-9006)
The initial dose of sorafenib will be 400 mg bid administered orally, on a continuous basis. A treatment cycle is considered to be 28 days. Intrapatient dose escalation will occur according to the following schedule, providing no grade 3 or 4 toxicities are observed (except for alopecia, nausea and vomiting); Day 1-28 400 mg bid, Day 29-56 600 mg bid, Day 57 onwards 800 mg bid. Subjects will continue on treatment until progression, unacceptable toxicity, subject withdraws consent or the decision is taken to stop the study following the analysis of response rates.
Interventions
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Sorafenib (Nexavar, BAY43-9006)
The initial dose of sorafenib will be 400 mg bid administered orally, on a continuous basis. A treatment cycle is considered to be 28 days. Intrapatient dose escalation will occur according to the following schedule, providing no grade 3 or 4 toxicities are observed (except for alopecia, nausea and vomiting); Day 1-28 400 mg bid, Day 29-56 600 mg bid, Day 57 onwards 800 mg bid. Subjects will continue on treatment until progression, unacceptable toxicity, subject withdraws consent or the decision is taken to stop the study following the analysis of response rates.
Eligibility Criteria
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Inclusion Criteria
* Metastatic clear cell RCC (renal cell carcinoma)
* Subjects with at least one uni-dimensional measurable lesion.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Memorial Sloan Kettering Cancer Center (MSKCC) good or intermediate category
* Life expectancy of at least 12 weeks.
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to treatment
* Signed informed consent must be obtained prior to any study specific procedures.
* Subjects must have received no prior systemic anticancer therapy for the treatment of their renal cell carcinoma
* Prior total nephrectomy
Exclusion Criteria
* History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
* Active clinically serious infections (\> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 3.0)
* Symptomatic metastatic brain or meningeal tumors unless the subject is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry.
* Subjects with evidence or history of bleeding diathesis
* Deep vein thrombosis and/or pulmonary embolus within 12 months of the start of treatment.
* Delayed healing of wounds, ulcers or bone fractures
* Subjects with pre-existing thyroid abnormality whose thyroid function cannot be maintained within the normal range by medication
* Subjects undergoing renal dialysis
* Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and three months after the completion of trial.
* Prior adjuvant sorafenib is excluded.
* Radiotherapy during study or within 3 weeks of start of study drug
* Major surgery within 4 weeks of start of study
* Investigational drug therapy outside of this trial during or within 4 weeks of study entry
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Bordeaux, , France
La Roche-sur-Yon, , France
Marseille, , France
Nantes, , France
Paris, , France
Tours, , France
Tübingen, Baden-Wurttemberg, Germany
Marburg, Hesse, Germany
Hanover, Lower Saxony, Germany
Mainz, Rhineland-Palatinate, Germany
Jena, Thuringia, Germany
Aviano, Pordenone, Italy
Milan, , Italy
Pavia, , Italy
Olsztyn, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
London, London, United Kingdom
Greater Manchester, Manchester, United Kingdom
Cardiff, South Glamorgan, United Kingdom
Glasgow, , United Kingdom
Countries
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Related Links
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Click here and search for Bayer product information provided by EMA
Other Identifiers
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2007-004875-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12913
Identifier Type: -
Identifier Source: org_study_id