Spots Global Cancer Trial Database for A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer
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Trial Identification
Brief Title: A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer
Official Title: A Phase I/II, Multi-center, Open-label Study of BEZ235, Administered Orally on a Continuous Daily Dosing Schedule in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
Study ID: NCT00620594
Interventions
Study Description
Brief Summary: This is a first-in-human, phase I/Ib clinical research study with BEZ235, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a dose escalation part followed by a safety dose expansion part: 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:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Catalunya, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Manchester, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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