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

This study is currently recruiting participants.
Verified January 2014 by Dana-Farber Cancer Institute
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Toni Choueiri, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01283048
First received: January 24, 2011
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BKM-120 with Bevacizumab 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283048

Contacts
Contact: Toni K Choueiri, MD 617-632-5456 Toni_Choueiri@dfci.harvard.edu

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Stephanie Morrissey, RN    617-632-2382      
Contact: Meghara Kane, RN    617-632-5264      
Principal Investigator: Toni K Choueiri, MD         
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Daniel Cho, MD    617-632-9250      
Contact: Janine Morrissey    (617) 632-9285    'jmorriss@bidmc.harvard.edu'   
Sponsors and Collaborators
Toni Choueiri, MD
Beth Israel Deaconess Medical Center
Investigators
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
ClinicalTrials.gov Identifier: NCT01283048     History of Changes
Other Study ID Numbers: 10-405
Study First Received: January 24, 2011
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Kidney Cancer
Avastin

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

ClinicalTrials.gov processed this record on April 15, 2014