NCT02508532

(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors

A Phase 1 Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Blueprint Medicines Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of avapritinib (formerly BLU-285), administered orally (PO), in adult patients with unresectable GIST or other relapsed or refractory solid tumors. The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2).

Conditions

• Gastrointestinal Stromal Tumors (GIST)
• Other Relapsed or Refractory Solid Tumors

Interventions

Type	Name	Description
DRUG	Avapritinib	avapritinib tablets

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-03-06
• Completion: 2021-06-03
• First posted: 2015-07-27
• Last updated: 2022-06-21
• Results posted: 2021-06-22

Locations

19 sites across 10 countries: United States, Belgium, France, Germany, Italy, Netherlands, Poland, South Korea, Spain, United Kingdom