Evaluate Safety and Tolerability in Dose Escalation of Sorafenib in Advanced Renal Cell Cancer
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|ClinicalTrials.gov Identifier: NCT01189370|
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Cancer||Drug: sorafenib||Phase 2|
In 2006, an estimated 38,890 people in the United States were diagnosed with kidney cancer and greater than 12,000 died from the disease. Kidney cancer that has spread to other parts of the body is one of the most treatment-resistant diseases. Standard of care treatment usually involves chemotherapy. Results from chemotherapy have been disappointing. Therefore, there is a need to develop additional safe and effective therapies to treat advanced kidney cancer.
Sorafenib (Nexavar®) has been approved by the FDA for the treatment of advanced kidney cancer. Sorafenib works by interfering with a type of protein in your body that determines how your kidney cells work and grow. Sorafenib at standard doses for 400mg(two pills) twice/day, given seven days/week, may slow progression of the disease for an average of three months but it is not expected to be curative. Preliminary studies have suggested higher doses of sorafenib may increase the chance that the tumor will shrink.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Efficacy and Tolerability of the Dose Escalation of Sorafenib in Advanced Renal Cell Cancer|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: Intra-Patient Dose Escalation: Sorafenib
All patients will receive a starting dose of sorafenib 400 mg by mouth twice daily. At four weeks, all patients who have not experienced Grade 3 or 4 toxicity will undergo dose escalation using a treatment schedule of days 1-5 days of each week. Doses will continue to be escalated every 4 weeks depending on tolerability and tumor response.
- Number of Participants Who Could Tolerate Each Dose Level [ Time Frame: 12 weeks ]Tolerability will be defined as successful completion of the dose level without experiencing Grade 3 or 4 toxicity.
- Overall Number of Participants That Had Disease Progression on Study [ Time Frame: 26 months ]Disease Progression as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189370
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Study Chair:||Stephen Williamson, MD||The University of Kansas - Cancer Center|