Clincosm LogoSign in Get a demo

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

Sponsor
Toni Choueiri, MD (Other)
Overall Status
Completed
CT.gov ID
NCT01283048
Collaborator
Beth Israel Deaconess Medical Center (Other)
32
Enrollment
3
Locations
1
Arm
60
Duration (Months)
10.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BKM-120 Bevacizumab
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: BKM-120 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 Names:
  • Avastin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. To determine the objective response proportion, progression-free survival, overall survival of the combination of BKM-120 and bevacizumab [2 years]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    2 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    3 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201

    Sponsors and Collaborators

    • Toni Choueiri, MD
    • Beth Israel Deaconess Medical Center

    Investigators

    • Principal Investigator: Toni K Choueiri, MD, Dana-Farber Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Toni Choueiri, MD, Assistant Professor of Medicine, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT01283048
    Other Study ID Numbers:
    • 10-405
    First Posted:
    Jan 25, 2011
    Last Update Posted:
    Sep 21, 2016
    Last Verified:
    Sep 1, 2016
    Keywords provided by Toni Choueiri, MD, Assistant Professor of Medicine, Dana-Farber Cancer Institute
    Kidney Cancer
    Avastin
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell
    Bevacizumab

    Study Results

    No Results Posted as of Sep 21, 2016