Bevacizumab and BKM-120 in Patients With Metastatic Renal Cell Carcinoma

Toni Choueiri, MD

Status and phase

Completed

Phase 1

Conditions

Renal Cell Carcinoma

Treatments

Drug: BKM-120 Bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT01283048

10-405

Details and patient eligibility

About

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.

Full description

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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