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An Open-Label, Multi-Center, Expanded Access Study of RAD001 in Patients With Metastatic Carcinoma of the Kidney Who Are Intolerant of or Have Progressed Despite Any AvailableVascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy


N/A
18 Years
N/A
Not Enrolling
Both
Metastatic Renal Cell Cancer

Thank you

Trial Information

An Open-Label, Multi-Center, Expanded Access Study of RAD001 in Patients With Metastatic Carcinoma of the Kidney Who Are Intolerant of or Have Progressed Despite Any AvailableVascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy

Inclusion Criteria


Inclusion criteria:

- ≥ 18 years old; metastatic renal cancer, intolerant of or failed sunitinib and/or
sorafenib

- Adequate bone marrow function, liver function, renal function

- Adequate birth control

Exclusion criteria:

- Previously received RAD001 or other mTOR inhibitors, known hypersensitivity to
rapamycin, chronic systemic treatment with corticosteroids or immunosuppressive
agents (prednisone ≤ 20 mg/day for adrenal insufficiency OK

- Topical or inhaled steroids OK)

- Active bleeding

- Uncontrolled angina, CHF, heart attack ≤ 6 months, uncontrolled diabetes

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001L2401

NCT ID:

NCT00655252

Start Date:

Completion Date:

Related Keywords:

  • Metastatic Renal Cell Cancer
  • Expanded access
  • metastatic renal cell cancer
  • progression despite VEGF receptors
  • Carcinoma, Renal Cell

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Missouri Cancer AssociatesColumbia, Missouri  65201
Henry Ford Health SystemDetroit, Michigan  48202
Cancer Centers of Florida, P.A.Orlando, Florida  
Gabrail Cancer CenterCanton, Ohio  44718
Highlands Oncology Group, PASpringdale, Arkansas  72764
Cleo Craig Memorial Cancer & Research ClinicLawton, Oklahoma  73505
MD Anderson Cancer Center - OrlandoOrlando, Florida  32806
Heartland Hematology-Oncology Associates, Inc.Kansas City, Missouri  64118
University of Colorado Health Sciences Center/Anschutz PavillionAurora, Colorado  12801
The Cancer Institute, St. Joseph Medical CenterTowson, Maryland  21209
Washington University/Siteman Cancer CenterSt. Louis, Missouri  63110
Blumenthal Cancer Center/Carolinas Medical CenterCharlotte, North Carolina  28203
Cliveland Clinic FoundationCleveland, Ohio  44195