Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Infigratinib

Criteria

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