Status:
COMPLETED
Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Novartis
Bayer
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 i...
Detailed Description
The drugs used in this trial are called targeted drugs as they target specific activities that are carried out by cancer cells that make them grow and spread. Sorafenib is an approved drug for the tre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00392821
Start Date
December 1 2006
End Date
October 1 2013
Last Update
June 6 2022
Active Locations (11)
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1
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
2
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
3
Wellstar Cancer Research
Marietta, Georgia, United States, 30060
4
Baptist Hospital East
Louisville, Kentucky, United States, 40207