Bevacizumab and BKM-120 in Patients With Metastatic Renal Cell Carcinoma
Status: Recruiting
Phase: Phase 1
Diagnosis: Kidney Cancer
NCT ID: NCT01283048
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-405
BKM-120 is a drug that may slow the growth of cancer cells. This drug has been used in laboratory experiments and information from those research studies suggests that this drug may help to slow the growth of renal cancer cells. In this research study, the investigators are testing the safety to BKM-120 at different dose levels. The investigators will also be studying how well tolerated BKM-120 is, and how effective BKM-120 can be in the treatment of kidney cancer.
Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center
Overall PI:
Toni Choueiri, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Daniel Cho, MD,
Beth Israel Deaconess Medical Center
Contacts:
Dana-Farber Cancer Institute:
Bon Lam, 617-632-5261,
bon_lam@dfci.harvard.edu
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Eligibility Criteria
Inclusion Criteria:
- Metastatic RCC with clear cell component or papillary RCC
- Life expectancy > 12 weeks
- Must have failed at least 1 prior anti-VEGF systemic therapy for metastatic RCC
Exclusion Criteria:
- Prior treatment with a P13K inhibitor or bevacizumab
- Untreated brain metastases
- Acute or chronic liver or pancreatic disease
- Major mood disorder
- Concurrent severe and/or uncontrolled medical condition
- Diabetes mellitus
- GI disease
- Currently taking therapeutic doses of warfarin sodium or any other
coumadin-derivative anticoagulant
- Pregnant or breastfeeding
- HIV positive
- History of another malignancy within 3 years except cured basal cell carcinoma of the
skin or excised in situ carcinoma of the cervix
- Uncontrolled hypertension