Know Cancer

or
forgot password

An Open-label, Multi-center Phase I Dose-finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors, Metastatic Breast Cancer, Metastatic Renal Cell Carcinoma

Thank you

Trial Information

An Open-label, Multi-center Phase I Dose-finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Probability of a Dose Limiting Toxicity (DLT) by the end of the first treatment cycle (DLT)

Outcome Description:

The maximum tolerated dose (MTD) and the dose limiting toxicities during the first cycle of treatment

Outcome Time Frame:

First treatment cycle (28 days)

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001X2109

NCT ID:

NCT01482156

Start Date:

January 2012

Completion Date:

May 2014

Related Keywords:

  • Advanced Solid Tumors
  • Metastatic Breast Cancer
  • Metastatic Renal Cell Carcinoma
  • Advanced solid tumors
  • Metastatic renal cell carcinoma (mRCC)
  • ER+/HER2-Metastatic breast cancer (MBC)
  • Dose finding study
  • mTOR
  • Pl3K
  • BEZ235
  • RAD001
  • Everolimus
  • Afinitor®
  • ER+/HER2- metastatic breast cancer
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Neoplasms

Name

Location

Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
Washington University School Of Medicine-Siteman Cancer Ctr Wash UniSt. Louis, Missouri  63110
Memorial Sloan Kettering Cancer Center MSKCC3New York, New York  10021
Medical University of South Carolina SCCharleston, South Carolina  29425
University of California at Los Angeles Dept. of UCLA (4)Los Angeles, California  90095
University of California at San Diego, Moores Cancer Ctr UCSDSan Diego, California  92103