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

NCT01804686 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ibrutinib

Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.

Sponsors & Collaborators

  • Pharmacyclics LLC.

    collaborator INDUSTRY

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-09
Primary Completion
2026-12-31
Completion
2027-08-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Colombia
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Puerto Rico
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01804686 on ClinicalTrials.gov