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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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00655252
Enrollment
Unknown
Registered
2008-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2011-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Renal Cell Cancer

Keywords

Expanded access, metastatic renal cell cancer, progression despite VEGF receptors

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.

Interventions

DRUGEverolimus

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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/

Countries

Australia, Austria, Belgium, Canada, Czechia, Germany, Hungary, Lebanon, Norway, Switzerland, Turkey (Türkiye), United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026