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Clinical Trial VICCPHI1364


A Phase Ib, Open-Label Study of Oral BGJ398 in Combination with Oral BYL719 in Adult Patients with Select Advanced Solid Tumors

Principal Investigator(s)

Ingrid Mayer


  • Protocol No. VICCPHI1364
  • Open Date: 03/07/2014
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: To determine the MTD and/or RDE of BGJ398 in combination with BYL719.
  • Disease Sites: Phase I
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: BGJ398; BYL719
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01928459
  • Secondary Protocol No: CBGJ398X2102


None Provided.


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


Inclusion Criteria:
• 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
Exclusion Criteria:
• 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