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

NCT ID: NCT01283048

Last Updated: 2016-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-09-30

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BKM-120 Bevacizumab

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

Group Type: EXPERIMENTAL

BKM-120 Bevacizumab

Intervention Type: DRUG

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

Interventions

BKM-120 Bevacizumab

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

Intervention Type: DRUG

Other Intervention Names

Avastin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Toni Choueiri, MD

OTHER

Sponsor Role: lead

Responsible Party

Toni Choueiri, MD

Assistant Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Toni K Choueiri, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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

Countries

United States

Other Identifiers

10-405

Identifier Type: -

Identifier Source: org_study_id