Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Toni Choueiri, MD, Dana-Farber Cancer Institute Identifier:
First received: January 24, 2011
Last updated: February 9, 2015
Last verified: February 2015

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.

Condition Intervention Phase
Renal Cell Carcinoma
Drug: BKM-120 Bevacizumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Dana-Farber Cancer Institute:

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 [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • To determine the objective response proportion, progression-free survival, overall survival of the combination of BKM-120 and bevacizumab [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: September 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BKM-120 with Bevacizumab
BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks
Drug: BKM-120 Bevacizumab
BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks
Other Name: Avastin

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01283048

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Toni Choueiri, MD
Beth Israel Deaconess Medical Center
Principal Investigator: Toni K Choueiri, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Toni Choueiri, MD, Assistant Professor of Medicine, Dana-Farber Cancer Institute Identifier: NCT01283048     History of Changes
Other Study ID Numbers: 10-405
Study First Received: January 24, 2011
Last Updated: February 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Kidney Cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on March 01, 2015