drugset / Trial / NCT01804686

A Long-term Extension Study of PCI-32765 (Ibrutinib)

NCT01804686 ↗

Phase 3 Active not recruiting 539 enrolled Janssen Research & Development, LLC Pharmacyclics LLC. · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.

Timeline

Start
2013-09-09
Primary completion
2026-12-31
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 140 mg Oral
Subject Ibrutinib Small molecule 280 mg Oral
Subject Ibrutinib Small molecule 420 mg Oral
Subject Ibrutinib Small molecule 560 mg Oral