Everolimus/Sorafenib or Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC)

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 31, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

April 30, 2016

Conditions
Locally Metastatic Malignant Neoplasm
Interventions
DRUG

Everolimus and sorafenib

"* Starting doses: everolimus 5 mg daily and sorafenib 400 mg BID - taken fasting, no food 1 hour before or 2 hours after dosing~* Everolimus and sorafenib are dosed continuously~(Note: everolimus and sorafenib are typically dosed in 28 day cycles, and sunitinib is typically dosed in 42 day cycles; for the purposes of this protocol to keep timing consistent, a cycle will be defined as 42 days of therapy)"

DRUG

Sunitinib monotherapy

"Starting dose: sunitinib 50 mg daily 4 weeks on, 2 weeks off - taken fasting, no food 1 hour before or 2 hours after dosing~(Note: sunitinib is typically dosed in 42 day cycles described above: 28 days treatment, 14 days off. For the purposes of this protocol, to keep timing consistent, a cycle will be defined as 42 days of therapy)"

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Andrea Harzstark

OTHER

NCT01616186 - Everolimus/Sorafenib or Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC) | Biotech Hunter | Biotech Hunter