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

Primary Purpose

Renal Cell Carcinoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BKM-120 Bevacizumab

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Kidney Cancer, Avastin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BKM-120 Bevacizumab

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To determine additional toxicity and safety information from the combination of BKM-120 and bevacizumab in an expanded cohort of patients at the MTD

To determine the objective response proportion, progression-free survival, overall survival of the combination of BKM-120 and bevacizumab

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

Full Information

NCT ID

NCT01283048

First Posted

January 24, 2011

Last Updated

September 19, 2016

Sponsor

Toni Choueiri, MD

Collaborators

Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01283048

Brief Title

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

Official Title

A Phase I Study of Bevacizumab and Escalation Doses of BKM-120 in Patients With Metastatic Renal Cell Carcinoma Who Failed Prior Systemic Therapies

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Toni Choueiri, MD

Collaborators

Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma

Keywords

Kidney Cancer, Avastin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BKM-120 Bevacizumab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BKM-120 Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To determine additional toxicity and safety information from the combination of BKM-120 and bevacizumab in an expanded cohort of patients at the MTD

Time Frame

2 year

Title

To determine the objective response proportion, progression-free survival, overall survival of the combination of BKM-120 and bevacizumab

Time Frame

2 years

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Toni K Choueiri, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Barbara Ann Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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