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

Completed · Phase 1

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID: NCT01283048
Run by: Toni Choueiri, MD
People needed: 32
Starts: 2011-09-01
Expected to finish: 2016-09-01
Last updated by the study team: 2016-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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