At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 115 enrolled
Drug / intervention
PCI-32765drug
Likely dose
PCI-32765 560 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Relapsed or Refractory Mantle Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating PCI-32765 for Mantle Cell Lymphoma. Completed, enrolled 115 participants across 18 sites in 4 countries.
Detailed Summary
The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL. The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMantle Cell Lymphoma
CountriesGermany, Poland, United Kingdom, United States
CollaboratorsJanssen Pharmaceuticals
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2010
Enrollment StartFeb 2011
Primary CompletionJan 2014
TodayJul 2026
First PostedNov 8, 2010
Enrollment StartFeb 1, 2011
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.7 years ago
Interventions
PCI-32765drug
560 mg daily