check_circleStudy Completed
Carcinoma, Renal Cell
Bayer Identifier:
100391
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer
Trial purpose
The purpose of the study is to:
- Find out if BAY 43-9006 prevents the growth of tumors
- For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time.
- Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers.
- Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.
- Find out if BAY 43-9006 prevents the growth of tumors
- For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time.
- Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers.
- Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
501Trial Dates
September 2002 - January 2007Phase
Phase 2Could I Receive a placebo
YesProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | M. D. Anderson Cancer Center - University of Texas | Houston, 77030, United States |
Completed | University of Pennsylvania | Philadelphia, 19104, United States |
Completed | Royal Marsden NHS Trust (Surrey) | Sutton, SM2 5PT, United Kingdom |
Completed | University of Chicago | Chicago, 60637, United States |
Terminated | Western Infirmary | Glasgow, G11 6NT, United Kingdom |
Completed | Institute for Drug Development | San Antonio, 78229, United States |
Completed | Royal Marsden Hospital (London) | London, SW3 6JJ, United Kingdom |
Primary Outcome
- Number of progressions post randomization to placebo or sorafenibdate_rangeTime Frame:12 weeks post randomizationenhanced_encryptionNoneSafety Issue:
Secondary Outcome
- Time to progressiondate_rangeTime Frame:Until Progression occursenhanced_encryptionNoneSafety Issue:
- Duration of objective tumor responsedate_rangeTime Frame:Time from initial Response to documented Tumor Progressionenhanced_encryptionNoneSafety Issue:
- Overall survival timedate_rangeTime Frame:At the End-of-Study visitenhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.#PL#J CLIN ONCOL 24 (16) 2505-2512 (2006)#PL#PubMed.Click here to find results for studies related to Bayer Healthcare products.