A Phase I Study of Bevacizumab and Escalation Doses of BKM-120 in Patients With Metastatic Renal Cell Carcinoma Who Failed Prior Systemic Therapies
Subjects will receive an intravenous infusion of Avastin on Day 1 and Day 15 of each month
(cycle). Subjects will take a daily oral dose of BKM-120 at the dose level assigned.
Subjects will have a clinic visit weekly during Cycle 1 and then on Day 1 and Day 15 of each
cycle for blood tests and physical exam.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose and dose limiting toxicities of the combination of BKM-120 and bevacizumab in metastatic renal cell carcinoma
Toni K Choueiri, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|