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

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01804686
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 9, 2013
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2029

Study Design

Enrollment
700 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib

Primary Outcome Measure

Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier ]

Central Contacts

Locations (32)

FacilityCityStateZIPSite coordinators
City of Hope Cancer CenterDuarteCalifornia91010-
University of California San Diego Medical CenterLa JollaCalifornia92093-
University of California Los AngelesLos AngelesCalifornia90095-
St. Joseph Hospital Center for Cancer Prevention and TreatmentOrangeCalifornia92868-
Stanford UniversityStanfordCalifornia94305-
Stanford University Medical CenterStanfordCalifornia94305-
Norwalk Medical GroupNorwalkConnecticut06850-
Northwest Georgia Oncology Centers PCMariettaGeorgia30060-
Northwestern University HospitalChicagoIllinois60611-
Indiana UniversityGoshenIndiana46526-
Kansas University Medical CenterWestwoodKansas66205-
Louisville Oncology Suburban - Norton Cancer InstituteLouisvilleKentucky40207-
Dana Farber Cancer CenterBostonMassachusetts02215-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Battle Creek Health SystmBattle CreekMichigan49016-
Karmanos Cancer Institute - Wayne State UniversityDetroitMichigan48201-
Washington UniversitySt LouisMissouri63110-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Hackensack University Medical CenterHackensackNew Jersey07601-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Weill Medical College of Cornell UniversityNew YorkNew York10021-
Southeastern Medical Oncology CenterGoldsboroNorth Carolina27534-
The Ohio State University- James Cancer HospitalColumbusOhio43210-
Willamette Valley Cancer CenterEugeneOregon97401-
Kaiser PermanentePortlandOregon97227-
University of Pennsylvania Medical CenterPhiladelphiaPennsylvania19104-
Avera Medical GroupSioux FallsSouth Dakota57105-
MD Anderson Cancer Center - University of TexasHoustonTexas77030-
University of VirginiaCharlottesvilleVirginia22908-
University of WashingtonSeattleWashington98109-
West Virginia UniversityMorgantownWest Virginia26506-
University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical ResearchMadisonWisconsin53705-

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City of Hope Cancer Center· Duarte, CAUniversity of California San Diego Medical Center· La Jolla, CAUniversity of California Los Angeles· Los Angeles, CASt. Joseph Hospital Center for Cancer Prevention and Treatment· Orange, CAStanford University· Stanford, CAStanford University Medical Center· Stanford, CA

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