NCT02160041

BGJ398 for Patients With Tumors With FGFR Genetic Alterations

Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 6 - BGJ398 for Patients With Tumors With FGFR Genetic Alterations

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this signal seeking study was to determine whether treatment with BGJ398 demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or hematologic malignancies to warrant further study.

Conditions

• Solid Tumor
• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	BGJ398	BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.

Timeline

• Start date: 2014-07-24
• Primary completion: 2018-04-30
• Completion: 2018-04-30
• First posted: 2014-06-10
• Last updated: 2019-06-18
• Results posted: 2019-06-18

Locations

56 sites across 1 country: United States

Regulatory

• FDA-regulated drug study