Trial intelligence / Profile preview

PCI-32765 (Ibrutinib) in Relapsed/Refractory Multiple Myeloma

NCT01478581Phase 2

Key facts

Status: Completed
Start: Mar 2012
Primary completion: Aug 2018
Countries: 1
Sponsor: Pharmacyclics
Modality: Small Molecules

Drugs: ibrutinib
Conditions: multiple myeloma (MM)

Overview

Phase 2, open-label trial of ibrutinib in multiple myeloma (MM) (4 cohorts), sponsored by Pharmacyclics. Primary endpoint: Clinical Benefit Response up to 60 months. Started Mar 2012; status: completed.

Design

4 arms

Study design: Non-randomizedOpen-label

Cohort 1
PCI-32765 420 mg per day
Cohort 2
PCI-32765 560 mg per day + Dexamethasone
Cohort 3
PCI-32765 840 mg per day
Cohort 4
PCI-32765 840 mg per day + Dexamethasone

Who it enrols

Patients with relapsed or relapsed/refractory multiple myeloma who have received 2-5 prior lines of therapy including an immunomodulator.

Endpoints

Primary

Clinical Benefit Responseup to 60 months

Secondary

Overall Response Rateup to 60 months
Maximum Observed Plasma Concentrationup to 60 weeks
Time to Maximum Observed Plasma Concentrationup to 60 weeks
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hoursup to 60 weeks
Terminal Elimination Half-lifeup to 60 weeks
Accumulation Ratio for AUC0-24hup to 60 weeks
Metabolite-to-Parent Ratio for Cmaxup to 60 weeks
Metabolite-to-Parent Ratio for AUC0-24hup to 60 weeks

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