Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors.
NCT ID: NCT00849550
Last Updated: 2012-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2009-07-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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XELOX-A-Ev
capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)
bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral
Interventions
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capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)
bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral
Eligibility Criteria
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Inclusion Criteria
* Must have a performance status of at least 70% (able to carry on most normal activities)
* Must have life expectancy of at least 3 months
* Must have adequate organ and marrow function as determined by lab tests
* Women of child-bearing potential and men must agree to use two forms of contraception
* Ability and willingness to sign a written informed consent document
* Histologically confirmed solid tumor malignancy that is metastatic or unresectable
Exclusion Criteria
* Patients who have received any other investigational agents within 28 days of the first day of study drug
* Patients with known CNS metastases
* History of other carcinomas within last 5 years (except non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer)
* Inadequately controlled hypertension
* Significant vascular disease
* Invasion or encasement of a major artery
* Evidence of bleeding diathesis or coagulopathy
* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 of study drug
* Serious illness or medical condition
* History of myocardial infarction, unstable angina, cardiac or other vascular stenting
* History of stroke
* HIV, Hepatitis C, Hepatitis B or other serious chronic infection
* Impairment of Gastrointestinal function or disease
* History of interstitial lung disease
* Patients who have had radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within 28 days of receiving study drug.
18 Years
ALL
No
Sponsors
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Roche-Genentech
INDUSTRY
Novartis
INDUSTRY
Herbert Hurwitz
OTHER
Responsible Party
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Herbert Hurwitz
Associate Professor of Medicine
Principal Investigators
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Herbert Hurwitz, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Ingalls Cancer Research Center
Harvey, Illinois, United States
Duke University Medical Center
Durham, North Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Countries
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Other Identifiers
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4265
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00015605
Identifier Type: -
Identifier Source: org_study_id