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
62 participants
INTERVENTIONAL
2013-10-31
2016-08-31
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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Metastatic breast cancer
Evaluation of safety and efficacy in patients with metastatic breast cancer whose tumors contain mutations to PIK3CA and alterations FGFR 1-3.
BGJ398
BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
BYL719
BYL719 will be administered orally once daily on each day of the 28-day cycle.
Solid tumor arm 1
Patients with solid tumors (except for colorectal cancer) whose tumors express mutations to PIK3CA.
BGJ398
BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
BYL719
BYL719 will be administered orally once daily on each day of the 28-day cycle.
Solid tumor arm 2
Patients with solid tumors (except for colorectal cancer) whose tumomrs express mutations to PIK3CA and alterations to FGFR 1-3
BGJ398
BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
BYL719
BYL719 will be administered orally once daily on each day of the 28-day cycle.
Dose escalation
To determine the MTD or RDE of the combination of BGJ398 with BYL719 in patients with advanced or metastastic solid tumors that express mutations to PIK3CA.
BGJ398
BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
BYL719
BYL719 will be administered orally once daily on each day of the 28-day cycle.
Interventions
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BGJ398
BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
BYL719
BYL719 will be administered orally once daily on each day of the 28-day cycle.
Eligibility Criteria
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Inclusion Criteria
* Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alterations in FGFR depending upon dose expansion cohort (either local or central determination)
* Measurable disease defined by RECIST v1.1
* ECOG performance status of ≤2
Exclusion Criteria
* Colorectal cancer (for patients enrolled to expansion part)
* Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ≥ 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus
* Use of medications that increase serum levels of phosphorus and/or calcium
* Inorganic phosphorus outside of normal limits
* Total and ionized serum calcium outside of normal limits
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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H. Lee Moffitt Cancer Center & Research Institute Moffitt 4
Tampa, Florida, United States
University of Michigan Comprehensive Cancer Center SC
Ann Arbor, Michigan, United States
Karmanos Cancer Institute Dept of Onc
Detroit, Michigan, United States
Washington University School of Medicine Onc Dept
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center Onc Dept
New York, New York, United States
Vanderbilt University Medical Center Dept of Onc
Nashville, Tennessee, United States
Cancer Therapy & Research Center / UT Health Science Center SC
San Antonio, Texas, United States
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Saint-Herblain, , France
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Modena, MO, Italy
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seville, Andalusia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Bellinzona, , Switzerland
Countries
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Related Links
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Results for CBGJ398X2102 from the Novartis Clinical Trials website
Other Identifiers
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CBGJ398X2102
Identifier Type: -
Identifier Source: org_study_id