A Phase IA, Multicenter, Open-label Dose Escalation Study of Oral BYL719, in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD (or RP2D) of oral BYL719 as single agent and in combination with fulvestrant
Incidence rate of dose limiting toxicities (DLT) (in the first cycle (of 28 days) of each investigated dose level).
February 2013
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CBYL719X2101
NCT01219699
October 2010
April 2014
Name | Location |
---|---|
Vanderbilt Univeristy SC | Nashville, Tennessee 37232 |
Massachusetts General Hospital MGH | Boston, Massachusetts 02114 |
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4) | Nashville, Tennessee 37203 |
MD Anderson Cancer Center/University of Texas MD Anderson | Houston, Texas 77030-4009 |
University of California San Francisco UCSF Mount Zion | San Francisco, California 94101 |