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

Completed · Phase 1

Conditions studied: Advanced Solid Tumors, Metastatic Breast Cancer, Metastatic Renal Cell Carcinoma

In brief

Study has two parts: 1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in patients with advanced solid tumors. 2. Dose-expansion: to assess safety and tolerability of RAD001 and BEZ235 at the MTD in patients with ER+/HER2- metastatic breast cancer and metastatic renal cell cancer

Key facts

Study ID

NCT01482156

Run by

Novartis Pharmaceuticals

People needed

46

Starts

2012-01-01

Expected to finish

2015-02-01

Last updated by the study team

2020-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients age 18 years or older
• In the dose finding phase, patients with histologically or cytologically confirmed advanced solid malignancies that are metastatic or unresectable
• In the dose expansion phase, the enrollment will be limited to patients with:
• Patients with metastatic renal cell carcinoma (mRCC) whose disease had progressed despite prior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine kinase inhibitor) therapy (at least one but no more than two lines of VEGFR-TKI therapy) Patients with metastatic breast cancer (MBC) which is ER+/HER2-, whose disease had progressed despite prior treatment with at least one but no more than two lines of chemotherapy and at least one prior line of endocrine therapy in the metastatic setting
• WHO performance status of 0-2
• Lab parameters within specifically defined criteria
• Patients with measurable disease per RECIST 1.0

You may not qualify if…

• Patients who have previously received mTOR inhibitors or PI3K inhibitors
• Patients with CNS metastases unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery plus the disease having been stable for at least 2 months without steroid use for at least 1 month prior to the first dose of RAD001 and BEZ235. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs.
• Major surgery within 2 weeks prior to study enrollment
• Patient taking anti-cancer drug concomitantly
• Received radiation within 4 weeks prior to study enrollment (2 weeks if limited field radiation)
• Receive chemotherapy 4 weeks prior to study enrollment
• Received live attenuated vaccines within 1 week prior to study enrollment
• History of HIV
• Any other severe and/or uncontrolled medical condition
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Highlands Oncology Group Dept of Highlands Oncology Grp — Fayetteville, Arkansas, United States
• Washington University School of Medicine Washington University (16) — St Louis, Missouri, United States
• Medical University of South Carolina SC — Charleston, South Carolina, United States
• Novartis Investigative Site — Wilrijk, Belgium
• Novartis Investigative Site — Bordeaux, France
• Novartis Investigative Site — Montellier Cedex 5, France
• Novartis Investigative Site — Verona, VR, Italy
• Novartis Investigative Site — Auckland, New Zealand
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — High Heaton, Newcastle Upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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