Evaluate Safety and Tolerability in Dose Escalation of Sorafenib in Advanced Renal Cell Cancer

Phase 2

Completed

• Conditions: Renal Cell Cancer
• Interventions: Drug: sorafenib

• Registration Number: NCT01189370
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The purpose of this study is to determine whether an increase in the dose of sorafenib when given over five instead of 7 days/week, will result in an improvement of the response rate (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib will control your cancer, without causing a significant increase in side effects.

Detailed Description

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-26
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2017-01-19
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-26
• Last Update Submitted: 2017-04-26
• Results First Posted: 2017-06-01
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intra-Patient Dose Escalation: Sorafenib	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Could Tolerate Each Dose Level	12 weeks	Tolerability will be defined as successful completion of the dose level without experiencing Grade 3 or 4 toxicity.

Secondary Outcome Measures

Name	Time	Method
Overall Number of Participants That Had Disease Progression on Study	26 months	Disease Progression as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States