A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer
NCT ID: NCT00620594
Last Updated: 2020-12-09
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
183 participants
INTERVENTIONAL
2006-12-21
2013-01-08
Brief Summary
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Dose escalation part (advanced solid tumors, including patients with breast cancer being treated with trastuzumab):
Patients receive oral BEZ235 once daily on days 1-28 of the first course. Courses will repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of at least 3 patients receive escalating doses of BEZ235, as single agent or in combination with trastuzumab, until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose expected to produce during the first course of treatment dose-limiting toxicity in 33% of patients.
Once the MTD has been defined, the safety expansion parts of the trial will be opened for enrollment.
Safety dose expansion part (advanced solid tumors, including patients with breast cancer being treated with trastuzumab):
Patients will be treated with BEZ235, as single agent or in combination with trastuzumab, given at the MTD, once daily. Treatment of patients will continue until disease progression or occurrence of unacceptable side effects.
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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BEZ235 Alone, Dose Escalation
BEZ235
BEZ235 + trastuzumab, Dose Escalation
BEZ235
BEZ235 Alone, MTD Expansion
BEZ235
BEZ235 + Trastuzumab, MTD Expansion
BEZ235
Interventions
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BEZ235
Eligibility Criteria
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Inclusion Criteria
\[Combination part\]: Patients with metastatic HER2+ Breast Cancer, after failure of trastuzumab treatment. Eligible patients will have to have tumors carrying molecular alterations of PIK3CA and/or PTEN.
\[Single agent safety expansion arm\]: Patients with histologically-confirmed, advanced unresectable solid tumors including CS patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists. Patients will be prescreened for molecular alterations affecting PIK3CA and/or PTEN. Patients with NSCLC will also be pre-screened for EGFR mutation.
Exclusion Criteria
* Prior treatment with a PI3K inhibitor
* Acute or chronic liver disease or renal disease
* Acute or chronic pancreatitis
* Patients with unresolved diarrhea ≥ CTCAE grade 2
* Impaired cardiac function or clinically significant cardiac diseases
* Patients with diabetes mellitus requiring insulin treatment
* Patients with known coagulopathies
* Patients with a history of photosensitivity reactions to other drugs
* Any of the following ophthalmological findings:
* Progressive eye disease that could lead to severe loss of visual acuity or visual field
* loss during the study period
* Inability to perform the ophthalmic procedures required in this protocol
* Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
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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University of California at Los Angeles JonssonComprehensiveCancerCtr
Los Angeles, California, United States
Yale University School of Medicine YaleCancerCtr-ClinTrialsOffice
New Haven, Connecticut, United States
Dana Farber Cancer Institute Clinical Trials ProjectManager
Boston, Massachusetts, United States
Nevada Cancer Institute NVCC - Huntsman
Las Vegas, Nevada, United States
Cancer Centers of the Carolinas CCC Faris
Greenville, South Carolina, United States
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(2)
Nashville, Tennessee, United States
Baylor Health Care System/Sammons Cancer Center Baylor- Sammons
Dallas, Texas, United States
University of Texas/MD Anderson Cancer Center Thoractic Head/Neck Med.Onc(2)
Houston, Texas, United States
Tyler Cancer Center TCC
Tyler, Texas, United States
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Manchester, , United Kingdom
Countries
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Related Links
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Results for CBEZ235A2101 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2006-004353-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBEZ235A2101
Identifier Type: -
Identifier Source: org_study_id