Expanded Access Study of RAD001 in Metastatic Renal Cell Cancer Patients Who Are Intolerant of or Who Have Failed Despite Prior Vascular Endothelial Growth Factor Therapy
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
No longer available
CT.gov ID
NCT00655252
Collaborator
(none)
85
Study Details
Study Description
Brief Summary
This expanded access study is designed to provide RAD001 to patients with MRCC who are without satisfactory treatment alternatives, until RAD001 becomes commercially available.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Expanded Access
Official Title:
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
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Highlands oncology Group, PA | Springdale | Arkansas | United States | 72764 |
| 2 | University of Colorado Health Sciences Center/Anschutz Pavillion | Aurora | Colorado | United States | 12801 |
| 3 | Cancer Centers of Florida, P.A. | Ocoee | Florida | United States | 34761 |
| 4 | MD Anderson Cancer Center - Orlando | Orlando | Florida | United States | 32806 |
| 5 | Indiana University Cancer center | Indianapolis | Indiana | United States | 46202 |
| 6 | The Cancer Institute, St. Joseph Medical Center | Towson | Maryland | United States | 21209 |
| 7 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 8 | Missouri Cancer Associates | Columbia | Missouri | United States | 65201 |
| 9 | Heartland Hematology-Oncology Associates, Inc. | Kansas City | Missouri | United States | 64118 |
| 10 | Washington University/Siteman Cancer Center | St. Louis | Missouri | United States | 63110 |
| 11 | Blumenthal Cancer Center/Carolinas Medical Center | Charlotte | North Carolina | United States | 28203 |
| 12 | Gabrail Cancer Center | Canton | Ohio | United States | 44718 |
| 13 | Cliveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 14 | Cleo Craig Memorial Cancer & Research Clinic | Lawton | Oklahoma | United States | 73505 |
| 15 | Cancer centers of the Carolinas | Greenville | South Carolina | United States | 29615 |
| 16 | Novartis Investigative Site | Malvern | Australia | ||
| 17 | Novartis Investigative Site | Graz | Austria | ||
| 18 | Novartis Investigative Site | Linz | Austria | ||
| 19 | Novartis Investigative Site | Salzburg | Austria | ||
| 20 | Novartis Investigative Site | Vienna | Austria | ||
| 21 | Novartis Investigative Site | Brussels | Belgium | ||
| 22 | Moncton Hospital | Moncton | New Brunswick | Canada | E1C 6Z8 |
| 23 | QE ll Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 24 | Royal Victoria Hospital | Barrie | Ontario | Canada | L4M 6M2 |
| 25 | Lakeridhe Health Corp - Oshawa | Oshawa | Ontario | Canada | L1G 2B9 |
| 26 | Sault Area Hospital - General Site | Sault Ste Marie | Ontario | Canada | P6A 2C4 |
| 27 | Les Urologues Associes du CHUM | Montreal | Quebec | Canada | H2X 1N8 |
| 28 | Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 29 | Saskatoon Cancer Center | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
| 30 | Novartis Investigative Site | Brno | Czech Republic | ||
| 31 | Novartis Investigative Site | Prague 2 | Czech Republic | ||
| 32 | Novartis Investigative Site | Prague | Czech Republic | ||
| 33 | Novartis Investigative Site | Augsburg | Germany | ||
| 34 | Novartis Investigative Site | Bautzen | Germany | ||
| 35 | Novartis Investigative Site | Berlin | Germany | ||
| 36 | Novartis Investigative Site | Bremen | Germany | ||
| 37 | Novartis Investigative Site | Chemnitz | Germany | ||
| 38 | Novartis Investigative Site | Dresden | Germany | ||
| 39 | Novartis Investigative Site | Erlangen | Germany | ||
| 40 | Novartis Investigative Site | Essen | Germany | ||
| 41 | Novartis Investigative Site | Frankfurt/Main | Germany | ||
| 42 | Novartis Investigative Site | Frankfurt | Germany | ||
| 43 | Novartis Investigative Site | Freiburg | Germany | ||
| 44 | Novartis Investigative Site | Fulda | Germany | ||
| 45 | Novartis Investigative Site | Goslar | Germany | ||
| 46 | Novartis Investigative Site | Hamburg | Germany | ||
| 47 | Novartis Investigative Site | Hannover | Germany | ||
| 48 | Novartis Investigative Site | Jena | Germany | ||
| 49 | Novartis Investigative site | Koln | Germany | ||
| 50 | Novartis Investigative Site | Leipzig | Germany | ||
| 51 | Novartis Investigative Site | Magdeburg | Germany | ||
| 52 | Novartis Investigative Site | Mainz | Germany | ||
| 53 | Novartis Investigative Site | Mannheim | Germany | ||
| 54 | Novartis Investigative Site | Munchen | Germany | ||
| 55 | Novartis Investigative site | Munster | Germany | ||
| 56 | Novartis Investidative Site | Nurnberg | Germany | ||
| 57 | Novartis Investigative Site | Offenburg | Germany | ||
| 58 | Novartis Investigative Site | Oldenburg | Germany | ||
| 59 | Novartis Investigative Site | Recklinghausen | Germany | ||
| 60 | Novartis Investigative Site | Rostock | Germany | ||
| 61 | Novartis Investigative Site | Tubingen | Germany | ||
| 62 | Novartis Investigative Site | Wuppertal | Germany | ||
| 63 | Novartis Investigative Site | Budapest | Hungary | ||
| 64 | Novartis Investigative Site | Beirut | Lebanon | ||
| 65 | Novartis Investigative Site | Alesund | Norway | ||
| 66 | Novartis Investigative Site | Oslo | Norway | ||
| 67 | Novartis Investigative Site | Geneva | Switzerland | ||
| 68 | Novartis Investigative Site | St. Gallen | Switzerland | ||
| 69 | Novartis Investigative Site | Ankara | Turkey | ||
| 70 | Novartis Investigative Site | Istanbul | Turkey | ||
| 71 | Novartis Investigative Site | Izmir | Turkey | ||
| 72 | Royal Bournemouth Hospital | Bournemouth | United Kingdom | BH7 7DW | |
| 73 | British Haematology and Oncology Centre | Bristol | United Kingdom | BS2 8ED | |
| 74 | Addenbrookes Hospital | Cambridge | United Kingdom | CB2 0QQ | |
| 75 | CRUK | Glasgow | United Kingdom | G61 1BD | |
| 76 | Southampton University Hospital NHS Trust, | Hampshire | United Kingdom | SO16 6YD | |
| 77 | Oncology & Haematology Clinical Tirals Unit | Leicester | United Kingdom | LE1 5WW | |
| 78 | Royal Free Hospital | London | United Kingdom | NW3 2QG | |
| 79 | Guy's and St. Thomas' NHS Foundation Trust | London | United Kingdom | SE1 9RT | |
| 80 | Royal Marsden Hospital | London | United Kingdom | SW3 6JJ | |
| 81 | The Christie Hospital | Manchester | United Kingdom | M20 9BX | |
| 82 | Newcastle General Hospital | Newcastle | United Kingdom | NE4 6BE | |
| 83 | Mount Vernon Cancer Centre | Northwood | United Kingdom | HA6 2RN | |
| 84 | St Luke's Wing, Royal Surrey County Hospital | Surrey | United Kingdom | GU2 7XX | |
| 85 | Singleton Hospital | Swansea | United Kingdom | SA2 8QA |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00655252
Other Study ID Numbers:
- CRAD001L2401
First Posted:
Apr 9, 2008
Last Update Posted:
Aug 19, 2011
Last Verified:
Aug 1, 2011
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms: