Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Advanced Solid TumorsMetastatic Breast CancerMetastatic Renal Cell Carcinoma
Interventions
DRUG

RAD001 + BEZ235

RAD001 is formulated as tablets of 2.5 mg and 5 mg strength, blistered in units of 10 tablets (for oral use) each. Blisters should be opened only at the time of dministration as the drug is both hygroscopic and light-sensitive. RAD001 should be administered immediately after a meal with a large glass of water. BEZ235 is supplied as 50-mg, 200-mg, 300-mg and 400-mg sachets (for oral use). BEZ235 is packaged in aluminum foil bags. Bags are packaged in a box. Patients will receive RAD001 in combination with BEZ235.

Trial Locations (10)

2610

Novartis Investigative Site, Wilrijk

29425

Medical University of South Carolina SC, Charleston

33075

Novartis Investigative Site, Bordeaux

34298

Novartis Investigative Site, Montellier Cedex 5

37126

Novartis Investigative Site, Verona

63110

Washington University School of Medicine Washington University (16), St Louis

72703

Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville

Unknown

Novartis Investigative Site, Auckland

08035

Novartis Investigative Site, Barcelona

NE7 7DN

Novartis Investigative Site, High Heaton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY