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

Phase 1

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: BKM-120 Bevacizumab

• Registration Number: NCT01283048
• Lead Sponsor: Toni Choueiri, MD

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Study Start: 2011-09
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BKM-120 Bevacizumab	BKM-120 Bevacizumab	BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose and dose limiting toxicities of the combination of BKM-120 and bevacizumab in metastatic renal cell carcinoma	2 year

Secondary Outcome Measures

Name	Time	Method
To determine additional toxicity and safety information from the combination of BKM-120 and bevacizumab in an expanded cohort of patients at the MTD	2 year
To determine the objective response proportion, progression-free survival, overall survival of the combination of BKM-120 and bevacizumab	2 years
To determine whether the BKM-120 and bevacizumab combination at the MTD is associated with concomitant changes in angiokines and PI3K pathway members in plasma and tumor samples	2 years

Trial Locations

Locations (3)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States