NCT01928459

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This dose escalation/dose expansion study will evaluate the combination of orally administered BGJ398 in combination with orally administered BYL719. During the dose escalation part, the MTD of the combination will be determined in patients whose advanced or metastatic tumors express mutations to PIK3CA. Once the MTD has been determined, the expansion part will begin. Patients will be addd to one of three arms based on the disease type and genetic changes. Patients with metastatic colorectal cancer are not eligible for participation in the expansion part.

Conditions

• Advanced Solid Tumors
• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	BGJ398	BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
DRUG	BYL719	BYL719 will be administered orally once daily on each day of the 28-day cycle.

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2013-08-26
• Last updated: 2020-12-09

Locations

22 sites across 12 countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Singapore, South Korea, Spain, Switzerland