Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors
NCT ID: NCT01482156
Last Updated: 2020-12-21
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
46 participants
INTERVENTIONAL
2012-01-31
2015-02-28
Brief Summary
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1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in patients with advanced solid tumors.
2. Dose-expansion: to assess safety and tolerability of RAD001 and BEZ235 at the MTD in patients with ER+/HER2- metastatic breast cancer and metastatic renal cell cancer
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RAD001 + BEZ235
Patients will receive first dose of RAD001 at 2.5mg/5mg/10 mg weekly or 2.5mg/5mg daily in combination of BEZ235 at 50 mg/100 mg/200 mg/300 mg/400 mg twice a day. In the initial cohort of the dose finding phase, patients will receive a single 2.5 mg dose of RAD001 on Cycle 1 Day 1 and the combination therapy of RAD001 2.5 mg/week and BEZ235 200 mg bid starting on Cycle 1 Day 8. Dose escalation phase: patients will start RAD001 and BEZ235 on Cycle 1 Day 1 with both study drugs being administered at the center. Dose expansion phase: the first 15 patients enrolled at selected sites will take RAD001 as monotherapy from Day 1 to Day 7 (for PK sampling). The combination therapy of RAD001 and BEZ235 will start on Day 8. All remaining patients will receive the combination therapy of RAD001 and BEZ235 starting on Cycle 1 Day 1.
RAD001 + BEZ235
RAD001 is formulated as tablets of 2.5 mg and 5 mg strength, blistered in units of 10 tablets (for oral use) each. Blisters should be opened only at the time of dministration as the drug is both hygroscopic and light-sensitive. RAD001 should be administered immediately after a meal with a large glass of water. BEZ235 is supplied as 50-mg, 200-mg, 300-mg and 400-mg sachets (for oral use). BEZ235 is packaged in aluminum foil bags. Bags are packaged in a box. Patients will receive RAD001 in combination with BEZ235.
Interventions
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RAD001 + BEZ235
RAD001 is formulated as tablets of 2.5 mg and 5 mg strength, blistered in units of 10 tablets (for oral use) each. Blisters should be opened only at the time of dministration as the drug is both hygroscopic and light-sensitive. RAD001 should be administered immediately after a meal with a large glass of water. BEZ235 is supplied as 50-mg, 200-mg, 300-mg and 400-mg sachets (for oral use). BEZ235 is packaged in aluminum foil bags. Bags are packaged in a box. Patients will receive RAD001 in combination with BEZ235.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In the dose finding phase, patients with histologically or cytologically confirmed advanced solid malignancies that are metastatic or unresectable
* In the dose expansion phase, the enrollment will be limited to patients with:
Patients with metastatic renal cell carcinoma (mRCC) whose disease had progressed despite prior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine kinase inhibitor) therapy (at least one but no more than two lines of VEGFR-TKI therapy) Patients with metastatic breast cancer (MBC) which is ER+/HER2-, whose disease had progressed despite prior treatment with at least one but no more than two lines of chemotherapy and at least one prior line of endocrine therapy in the metastatic setting
* WHO performance status of 0-2
* Lab parameters within specifically defined criteria
* Patients with measurable disease per RECIST 1.0
Exclusion Criteria
* Patients with CNS metastases unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery plus the disease having been stable for at least 2 months without steroid use for at least 1 month prior to the first dose of RAD001 and BEZ235. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs.
* Major surgery within 2 weeks prior to study enrollment
* Patient taking anti-cancer drug concomitantly
* Received radiation within 4 weeks prior to study enrollment (2 weeks if limited field radiation)
* Receive chemotherapy 4 weeks prior to study enrollment
* Received live attenuated vaccines within 1 week prior to study enrollment
* History of HIV
* Any other severe and/or uncontrolled medical condition
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States
Washington University School of Medicine Washington University (16)
St Louis, Missouri, United States
Medical University of South Carolina SC
Charleston, South Carolina, United States
Novartis Investigative Site
Wilrijk, , Belgium
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Montellier Cedex 5, , France
Novartis Investigative Site
Verona, VR, Italy
Novartis Investigative Site
Auckland, , New Zealand
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
High Heaton, Newcastle Upon Tyne, United Kingdom
Countries
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Related Links
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Results for CRAD001X2109 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2011-001425-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAD001X2109
Identifier Type: -
Identifier Source: org_study_id