Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease

Part of paid clinical trials in Duarte, California.

Sponsor
Pharmacyclics LLC.
Study ID
NCT02195869
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.

Key Dates

Start date
Jul 14, 2014
Status verified
Jun 2019
Primary completion
Sep 15, 2017
Completion
Sep 15, 2017

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Dose Level 1
    Subjects receive daily dose of 420 mg of Ibrutinib capsules
  • Experimental: Phase 1b: Dose Level 2
    Subjects receive daily dose of 280 mg of Ibrutinib capsules
  • Experimental: Phase 1b: Dose Level 3
    Subjects receive daily dose of 140 mg of Ibrutinib capsules
  • Experimental: Phase 2
    Subjects receive daily dose of recommended phase 2 dose

Primary Outcome Measure

Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD. [ Time Frame: 28 treatment days after last subject enrolled in Phase 1 dose level(s). ]

Locations (10)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
University of California, San FranciscoSan FranciscoCalifornia94143-
Stanford UniversityStanfordCalifornia94305-
Emory University, Winship Cancer InstituteAtlantaGeorgia30322-
Dana Farber Cancer InstituteBostonMassachusetts02215-
University of MinnesotaMinneapolisMinnesota55455-
Washington University School of MedicineSt LouisMissouri63110-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Vanderbilt University Medical Center, Henry-Joyce Cancer ClinicNashvilleTennessee37232-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAUniversity of California, San Francisco· San Francisco, CAStanford University· Stanford, CAEmory University, Winship Cancer Institute· Atlanta, GADana Farber Cancer Institute· Boston, MAUniversity of Minnesota· Minneapolis, MN

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