Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being done in 2 parts. The first part is to determine the dose of RAD001 that should be used in combination with sorafenib. The second part is using the above determined dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against advanced kidney cancer.

Participants will be asked to keep a pill diary.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: Bayer; Novartis
• Treatments: Everolimus; Niacinamide; Sirolimus; Sorafenib

Criteria

Inclusion Criteria:

• Clinically documented metastatic or unresectable locally recurrent clear cell renal carcinoma

• Previous removal of kidney except if the size of the tumor was less than 5 cm or there was extensive liver or bone metastasis

• May have had no prior chemotherapy or up to 1 prior treatment regimen with immunotherapy or chemotherapy

• Performance status of 0-1

• Measurable disease

• Adequate liver, renal, and bone marrow function

• Must be able to give written informed consent

• Women able to become pregnant must have a negative pregnancy test

• Must be 18 or over

• Must be able to swallow pills

Exclusion Criteria:

• Prior treatment with sorafenib or m-TOR inhibitors

• History of acute MI within the last 6 months

• Active brain metastasis or patients with meningeal metastases

• Prior treatment for another cancer in the last 5 years

• Prior bleeding problems; coughing up or vomiting blood

• Non-healing wounds, ulcer, or long bone fracture

• Chronic use of systemic steroids or immunosuppressive agents

• Uncontrolled hypertension

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.