Advanced solid tumors, metastatic solid tumors
Conditions
Interventions
Product Code: BGJ398 5mg
Pharmaceutical Form: Capsule, hard
Other descriptive name: BGJ398
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Code: BGJ398
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anticancer 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 other, protocol-defined criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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 other, protocol-defined criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: tolerability, ORR, PFS;Primary end point(s): Incidence rate of dose limiting toxicities (DLTs) of the combination of BGJ398 with BYL719;Timepoint(s) of evaluation of this end point: approx. 8 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety and tolerability of BGJ398/BYL719 combination at the recommended dose for expansion (RDE) 2. Overall response rate 3. Progression free survival 4. Time vs. concentration profile of BGJ398 and BYL719;Timepoint(s) of evaluation of this end point: 1. Every 28 days from baseline visit until end of study visit 2 and 3. Every two months from the date of baseline CT scan 4. Every 28 days for up to 10 cycles | — |
Countries
Australia, Belgium, Canada, France, Germany, Hong Kong, Italy, Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed