Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors, Metastatic Solid Tumors

In brief

To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.

Key facts

Study ID

NCT01928459

Run by

Novartis Pharmaceuticals

People needed

62

Starts

2013-10-01

Expected to finish

2016-08-01

Last updated by the study team

2020-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anti-cancer therapy exists
• 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

You may not qualify if…

• Prior PI3Ki or selective FGFR inhibitor treatment (for patients enrolled to expansion part)
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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