A Phase Ib/II Trial of LEE011 in Combination With Everolimus (RAD001) and Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive, Her2- Locally Advanced or Metastatic Breast Cancer
The primary purpose of the phase Ib part of this study is to determine the maximum tolerated
dose(s) (MTD(s)) and/or recommended phase II dose (RP2D) of LEE011 + everolimus + exemestane
in patients with ER+ Her2- advanced breast cancer. This part of the study will also assess
safety, tolerability, and PK of the LEE011 + exemestane, LEE011 + everolimus + exemestane
combinations.
The phase II part of the study will evaluate the triple combination of LEE011 + everolimus +
exemestane and the double combination of LEE011 + exemestane in comparison to everolimus +
exemestane. Safety, tolerability and PK (in a subset of patients) will also be assessed.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of dose limiting toxicity (DLT)- Phase Ib
DLT is defined as treatment-related toxicity (classified according Common Toxicity Criteria for Adverse Events (CTCAE) Version 4) occurring during the first 28 treatment days and meeting specific protocol-predefined criteria. The information will be integrated in a Bayesian logistic regression model with overdose control to estimate the maximum tolerated dose (MTD).
Day 1- Day 28 of Cycle 1 (28 day cycle)
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CLEE011X2106
NCT01857193
August 2013
June 2016
Name | Location |
---|---|
Wayne State University/Karmanos Cancer Institute Dept of Onc | Detroit, Michigan 48201 |
Massachusetts General Hospital Onc Dept | Boston, Massachusetts 02114 |
Memorial Sloan Kettering Cancer Center Oncology Dept. | New York, New York 10021 |
MD Anderson Cancer Center/University of Texas Onc Dept | Houston, Texas 77030-4009 |