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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Toni Choueiri, MD
Study ID
NCT01283048
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

First listed
Jan 25, 2011
Start date
Sep 30, 2011
Status verified
Sep 2016
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BKM-120 Bevacizumab
    BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks

Primary Outcome Measure

To determine the maximum tolerated dose and dose limiting toxicities of the combination of BKM-120 and bevacizumab in metastatic renal cell carcinoma [ Time Frame: 2 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-

Find similar trials in Boston, MA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MABarbara Ann Karmanos Cancer Institute· Detroit, MI

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