Clinical trial · Interventional
Phase 1b Trial of BGJ398/BYL719 in Solid Tumors
A Phase Ib, Open-label Study of Oral BGJ398 in Combination With Oral BYL719 in Adult Patients With Select Advanced Solid Tumors
NCT01928459CI-TRIAL-00048734completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BGJ398 | Drug | Infigratinib | ALIAS |
| BYL719 | Drug | Alpelisib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Metastatic breast cancer
- description
- Evaluation of safety and efficacy in patients with metastatic breast cancer whose tumors contain mutations to PIK3CA and alterations FGFR 1-3.
- interventionNames
- Drug: BGJ398
- Drug: BYL719
- type
- EXPERIMENTAL
- label
- Solid tumor arm 1
- description
- Patients with solid tumors (except for colorectal cancer) whose tumors express mutations to PIK3CA.
- interventionNames
- Drug: BGJ398
- Drug: BYL719
- type
- EXPERIMENTAL
- label
- Solid tumor arm 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.