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

This study has been completed.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC Identifier:
First received: October 25, 2006
Last updated: February 10, 2014
Last verified: February 2014

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.

Condition Intervention Phase
Kidney Cancer
Drug: Sorafenib
Drug: RAD001
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Sorafenib (Nexavar) and RAD001 (Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Progression-Free Survival. [ Time Frame: 18 months ]
    Progression is Defined Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% Increase in the Sum of the Longest Diameter of Target Lesions, or a Measurable Increase in a Non-target Lesion, or the Appearance of New Lesions.

Enrollment: 78
Study Start Date: December 2006
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 and Sorafenib
RAD001 and Sorafenib
Drug: Sorafenib
Other Name: Nexavar
Drug: RAD001
Other Name: Everolimus, Zortress, Certican

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 treatment of advanced kidney cancer. RAD001 is an experimental drug that has been used in other research studies with other types of cancer. In this trial, the use of RAD001 and sorafenib together for the treatment of kidney cancer is experimental. In the Phase I portion of this study 13-16 patients will be treated with the same dose of sorafenib and different doses of RAD001. The purpose is to see what is a safe dose of RAD001 when combined with sorafenib in the treatment of kidney cancer. Once this dose of RAD001 is determined, about 65 more patients will be treated to see how effective this combination of drugs is against this kidney cancer.

Both of these drugs are taken by mouth. Sorafenib will be taken twice a day. RAD001 is taken by mouth weekly. Patients will be able to continue treatment as long as their disease does not worsen or side effects become intolerable.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00392821

United States, Florida
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Wellstar Cancer Research
Marietta, Georgia, United States, 30060
United States, Kentucky
Baptist Hospital East
Louisville, Kentucky, United States, 40207
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
United States, New Jersey
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, United States, 07960
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, South Carolina
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Principal Investigator: John D Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00392821     History of Changes
Other Study ID Numbers: SCRI GU 44
Study First Received: October 25, 2006
Results First Received: February 10, 2014
Last Updated: February 10, 2014

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Micronutrients processed this record on April 24, 2017