- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01283048
Bevacizumab and BKM-120 in Patients With Metastatic Renal Cell Carcinoma
September 19, 2016 updated by: Toni Choueiri, MD
A Phase I Study of Bevacizumab and Escalation Doses of BKM-120 in Patients With Metastatic Renal Cell Carcinoma Who Failed Prior Systemic Therapies
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Michigan
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BKM-120 Bevacizumab
BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks
|
BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 year
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To determine the objective response proportion, progression-free survival, overall survival of the combination of BKM-120 and bevacizumab
Time Frame: 2 years
|
2 years
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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
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Toni K Choueiri, MD, Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
January 24, 2011
First Submitted That Met QC Criteria
January 24, 2011
First Posted (Estimate)
January 25, 2011
Study Record Updates
Last Update Posted (Estimate)
September 21, 2016
Last Update Submitted That Met QC Criteria
September 19, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- 10-405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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