A Phase 2 of Entospletinib in Subjects With Relapsed or Refractory Hematologic Malignancies

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overPharmaceutical / IndustryGS-US-339-0102
NCT01799889

Trial Description

Summary

This study is to evaluate the efficacy, safety, tolerability, and pharmacodynamics of entospletinib. Participants with the following hematological tumor types will be enrolled into the study: relapsed or refractory chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), or non-FL indolent non-Hodgkin lymphomas (iNHL; including lymphoplasmacytoid lymphoma/ Waldenström macroglobulinemia [LPL/WM], small lymphocytic lymphoma [SLL], or marginal zone lymphoma [MZL]).

Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of B-cell iNHL, DLBCL, MCL, or CLL as documented by medical records and with histology based on criteria established by the World Health Organization
  • For institutions that have Phase 3 protocols studying idelalisib (GS-1101); subjects with malignancies being studied in these protocols must have failed screening in the respective idelalisib protocol
  • Prior treatment for lymphoid malignancy requiring treatment for progressive disease
  • Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
  • All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before the start of study drug
  • Karnofsky performance status of ≥ 60
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Known histological transformation from iNHL or CLL to an aggressive form of non-Hodgkin lymphoma (ie, Richter transformation)
  • Known active central nervous system or leptomeningeal lymphoma
  • Presence of known intermediate- or high-grade myelodysplastic syndrome
  • Current therapy with agents that reduce gastric acidity, including but not limited to antacids, H2 inhibitors, and proton pump inhibitors
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug
  • Ongoing liver injury
  • Ongoing or recent hepatic encephalopathy
  • Ongoing drug-induced pneumonitis
  • Ongoing inflammatory bowel disease
  • Ongoing alcohol or drug addiction
  • Pregnancy or breastfeeding
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing immunosuppressive therapy
  • Concurrent participation in an investigational drug trial with therapeutic intent

Trial Contact Information

Trial Lead Organizations/Sponsors

Gilead Sciences

    Steve Abella, M.D., Study Director
    Gilead Study Team

    Email: GS9973alerts@gilead.com

    Trial Sites

    U.S.A.

    Alabama
    Birmingham

    UAB Comprehensive Cancer Center

    Elizabeth Busby
    Ph: 205-934-0337
    Email: lizbusby@uab.edu

    Andres Forero-Torres
    Principal Investigator

    Arizona
    Tucson

    Arizona Oncology Associates

    Janice Miller
    Ph: 520-886-0206
    Email: janice.miller@usoncology.com

    Julie Klinker
    Ph: 520-886-0206
    Email: julie.klinker@usoncology.com

    Christopher Di Simone, MD
    Principal Investigator

    California
    Duarte

    City of Hope Comprehensive Cancer Center

    Jaemee Bautista
    Ph: 626-256-4673Ext. 63033
    Email: jbautista@coh.org

    Pennie Lam
    Ph: 626-256-4673Ext. 63192
    Email: hilam@coh.org

    Robert Chen, MD
    Principal Investigator

    Sacramento

    Sutter Medical Group

    Christina Dyer
    Ph: 916-454-6962
    Email: dyercj@sutterhealth.org

    Michael Carroll
    Principal Investigator

    San Diego

    Sharp Memorial Hospital Cancer Center

    Cathy Wood
    Ph: 858-939-5067
    Email: Cathy.wood@sharp.com

    Karen Graham
    Ph: 858-939-5068
    Email: Karen.graham@sharp.com

    Alfred Saleh, MD
    Principal Investigator

    San Francisco

    Pacific Hematology/Oncology Associates

    Madeline Decker
    Ph: 415-600-3613
    Email: DeckerM@cpmcri.org

    Caroline Behler
    Principal Investigator

    Colorado
    Boulder

    Rocky Mountain Cancer Centers, LLP

    Heather Harsh
    Ph: 303-388-4876
    Email: heather.harsh@usoncology.com

    Bobbie Donnachaidh
    Ph: 303-388-4876
    Email: bobbie.donnachaidh@usoncology.com

    David Andorsky, MD
    Principal Investigator

    Denver

    Kaiser Permanente of Colorado

    Joshua Gordon
    Ph: 303-764-5056
    Email: Josh.B.Gordon@kp.org

    Alex Menter
    Principal Investigator

    Connecticut
    Southington

    Cancer Center of Central Connecticut - Southington

    Mark Turney
    Ph: 860-621-9316
    Email: mjt2716@sbcglobal.net

    Peter D. Byeff
    Principal Investigator

    Florida
    Ft. Myers

    Florida Cancer - Colonial

    Nancy Solak
    Ph: 239-938-0800
    Email: nsolak@flcancer.com

    Stacy Gilmore
    Ph: 239-938-0800
    Email: sgilmore@flcancer.com

    Lowell Hart, MD
    Principal Investigator

    Hollywood

    Memorial Cancer Institute at Memorial Regional Hospital

    Deneise Francis
    Ph: 954-965-6390
    Email: Dfrancis@mhs.net

    Alvaro Alencar, MD
    Principal Investigator

    Jacksonville

    Baptist Cancer Institute - Jacksonville

    Jeanine Richmond
    Ph: 904-202-7070
    Email: Jeanine.richmond@bmcjax.com

    Andrea Canto
    Ph: 904-202-7073
    Email: andrea.canto@bmcjax.com

    Troy Guthrie, Jr, MD
    Principal Investigator

    Georgia
    Atlanta

    Northside Hospital

    Robin Williams
    Ph: 770-496-9419
    Email: Robin.Williams@gacancer.com

    Charles Sykes
    Ph: 478-745-6130Ext. x128
    Email: charles.sykes@gacancer.com

    Mansoor Noorali Saleh
    Principal Investigator

    Lawrenceville

    Gwinnett Hospital System Dba The Center for Cancer Care

    Kathy Frank
    Ph: 678-533-1567
    Email: kfrank@suburban-hemonc.com

    Christopher Hagenstad, MD
    Principal Investigator

    Marietta

    Northwest Georgia Oncology Centers, PC - Marietta Center

    Mary Gilley
    Ph: 770-281-5131
    Email: mgilley@ngoc.com

    Latanya Alphonse
    Ph: 770-281-5118
    Email: lalphonse@ngoc.com

    Robert C. Hermann
    Principal Investigator

    Illinois
    Niles

    Cancer Care and Hematology Specialists of Chicagoland - Niles

    Pian Moy
    Ph: 847-827-9060
    Email: pian.moy@usoncology.com

    Heather Lee
    Ph: 847-259-0624
    Email: heather.lee@usoncology.com

    Leonard Klein, MD
    Principal Investigator

    Louisiana
    Baton Rouge

    Hematology Oncology Clinic, PLLC

    Evie Key
    Ph: 225-761-3951
    Email: eviekey@hoc.brcoxmail.com

    Kathy Probst
    Ph: 225-761-3952
    Email: eviekey@hoc.brcoxmail.com

    Michael Castine, MD
    Principal Investigator

    Massachusetts
    Boston

    Tufts Medical Center Cancer Center

    Colleen Loiselle
    Ph: 617-636-2683
    Email: cloiselle@tuftsmedicalcenter.org

    Shrikar Rajagopal
    Ph: 617-636-2883
    Email: srajagopal@tuftsmedicalcenter.org

    Andreas Klein
    Principal Investigator

    Michigan
    Ann Arbor

    University of Michigan Health System

    Tina Willbee
    Ph: 734-936-3879
    Email: tpelton@med.umich.edu

    Erica Chapman
    Ph: 734-232-0716
    Email: echapman@med.umich.edu

    Daniel Lebovic, MD
    Principal Investigator

    Detroit

    Barbara Ann Karmanos Cancer Institute

    Christy Houde
    Ph: 313-576-9831
    Email: houdec@karmanos.org

    Courtney Wolf
    Ph: 313-576-9376
    Email: wolfc@karmanos.org

    Jay Yang, MD
    Principal Investigator

    Minnesota
    Woodbury

    Minnesota Oncology Hematology, PA

    Lori Green
    Ph: 651-735-7414
    Email: lori.green@usoncology.com

    Holly Desma
    Ph: 651-735-7414
    Email: hollyjo.desma@usoncology.com

    Patrick Flynn, MD
    Principal Investigator

    Mississippi
    Hattiesburg

    Hattiesburg Clinic, PA at Forrest General

    Tammy McBeth
    Ph: 601-288-2495
    Email: tmcbeth@forrestgeneral.com

    John Hrom, MD
    Principal Investigator

    Nebraska
    Omaha

    Oncology Hematology West PC dba Nebraska Cancer Specialists

    Anne Marie Fredrichs
    Ph: 402-691-6971
    Email: afredrichs@nebraskacancer.com

    Faye Park
    Ph: 402-691-6971
    Email: fpark@nebraskacancer.com

    Stefano Tarantolo, MD
    Principal Investigator

    New Jersey
    Morristown

    Hematology-Oncology Associates of Northern New Jersey, PA at Carol G. Simon Cancer Center

    Michelle MacKenzie
    Ph: 973-538-3593Ext. 2338
    Email: mmackenzie@hoannj.com

    Charles M. Farber
    Principal Investigator

    New York
    Lake Success

    Clinical Research Alliance, Incorporated

    Judith Lovecchio
    Ph: 516-488-2918Ext. 101
    Email: jlovecchio@researchcra.com

    Morton Coleman
    Principal Investigator

    North Carolina
    Chapel Hill

    Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Elizabeth Tita
    Ph: 919-966-4432
    Email: elizabeth_tita@med.unc.edu

    Steven Park, MD
    Principal Investigator

    Ohio
    Canton

    Gabrail Cancer Center - Canton Office

    Carrie Smith
    Ph: 330-492-3345Ext. 208
    Email: csmith@gabrailcancercenter.com

    Nashat Yousif Gabrail
    Principal Investigator

    Cincinnati

    Oncology Hematology Care, Incorporated - Blue Ash

    Nicole Given
    Ph: 513-751-2273Ext. 27110
    Email: ngiven@ohcare.com

    Shaundra Izzo
    Ph: 513-751-2273
    Email: sizzo@ohcare.com

    James Essell, MD
    Principal Investigator

    Cleveland

    Cleveland Clinic Taussig Cancer Center

    Sarah Cornman
    Ph: 216-444-4432
    Email: Cornmas@ccf.org

    Basel Rouphail
    Ph: 216-636-5643
    Email: rouphab@ccf.org

    Mitchell Smith, MD
    Principal Investigator

    Oregon
    Springfield

    Williamette Valley Cancer Center and Research Institute

    Wade Carson
    Ph: 541-741-3451
    Email: wade.carson@usoncology.com

    Betty Olguin
    Ph: 541-741-3451
    Email: betty.goracke-olguin@usoncology.com

    Jeff Sharman, MD
    Principal Investigator

    South Carolina
    Greenville

    Bon Secours St. Francis Health System

    Amber Lewis
    Ph: 864-255-1517
    Email: Amber_Lewis2@bshsi.org

    Howland Crosswell
    Principal Investigator

    South Dakota
    Watertown

    Prairie Lakes Cancer Center

    Lisa Campbell
    Ph: 605-882-6800
    Email: lisa.campbell@prairielakes.com

    Valerie Jensen
    Ph: 605-882-6800
    Email: valerie.jensen@prairielakes.com

    Bipinkumar Amin, MD
    Principal Investigator

    Tennessee
    Bristol

    Wellmont Medical Associates Oncology and Hematology

    Tracy Bowman
    Ph: 423-968-2311
    Email: Tracy.Bowman@wellmont.org

    Harsha Vardhana
    Principal Investigator

    Chattanooga

    Associates in Oncology and Hematology

    James Slatton
    Ph: 423-622-2337
    Email: jslatton@chemodok.com

    Jitendra Gandhi
    Principal Investigator

    Germantown

    Jones Clinic PC

    Catherine Morningstar
    Ph: 901-685-5969
    Email: cmorningstar@jonescancerclinic.com

    Lori Lynch
    Ph: 901-685-5969
    Email: llynch@jonescancerclinic.com

    Clyde Michael Jones
    Principal Investigator

    Nashville

    Tennessee Oncology, PLLC - Baptist Medical Building

    Sara Colding
    Ph: 615-524-4127
    Email: sara.colding@scresearch.net

    Ian Flinn, MD, PhD
    Principal Investigator

    Texas
    Arlington

    Arlington Cancer Center - Arlington

    Nikki Rogers
    Ph: 817-261-4906
    Email: nikkirogers@texashealth.org

    Alfred DiStefano, MD
    Principal Investigator

    Austin

    Texas Oncology - Midtown Austin

    Andreas Shaw
    Ph: 512-614-5935
    Email: Andrea.Shaw@usoncology.com

    Lauren Hendrix
    Ph: 512-341-8724
    Email: lauren.hendrix@usoncology.com

    Jason Melear, MD
    Principal Investigator

    Dallas

    Texas Oncology, PA at Texas Cancer Center Medical City Dallas

    Rhonda Waldrop
    Ph: 972-566-4291
    Email: rhonda.waldrop@usoncology.com

    Karen Holck
    Ph: 972-566-4291
    Email: karen.holck@usoncology.com

    Michael Savin, MD
    Principal Investigator

    Fort Worth

    Center for Cancer and Blood Disorders - Fort Worth

    Melissa Sottosanti
    Ph: 817-759-7023
    Email: msottosanti@txcc.com

    Robin Rutt
    Ph: 817-759-7000
    Email: rrutt@txcc.com

    Ray Page, DO, PhD
    Principal Investigator

    San Antonio

    Cancer Care Centers of South Texas - Medical Center

    Debora Lind
    Ph: 210-595-5300
    Email: debora.lind@usoncology.com

    Roger Lyons, MD
    Principal Investigator

    San Antonio Tumor and Blood Clinic - Madison Oaks

    Maria Lopez
    Ph: 210-656-7177
    Email: Maria.lopez2@usoncology.com

    Julie MacLaren
    Ph: 210-656-7177
    Email: Julie.maclaren@usoncology.com

    David Gordon, MD
    Principal Investigator

    Virginia
    Fairfax

    Virginia Cancer Specialists

    Lisa Chapuran
    Ph: 703-280-5390
    Email: lisa.chapuran@usoncology.com

    Janine Prime
    Ph: 703-280-5390
    Email: janine.prime@usoncology.com

    Dipti Patel-Donnelly, MD
    Principal Investigator

    Richmond

    Virginia Cancer Institute - West End

    David Nilson
    Ph: 804-288-7159
    Email: dnilson@vacancer.com

    James Khatcheressian, MD
    Principal Investigator

    Washington
    Kennewick

    Columbia Basin Hematology

    Heather Johansen, MD
    Ph: 509-783-4637Ext. 1
    Email: hjohansen@cbho.org

    Dina Kasper
    Ph: (509) 783-4637
    Email: dkasper@cbho.org

    Thomas Rado, MD
    Principal Investigator

    Seattle

    University Cancer Center at University of Washington Medical Center

    Kari Blankenship
    Ph: 206-288-1172
    Email: kblanken@seattlecca.org

    Alisa Bradford
    Ph: 206-288-6747
    Email: abradfor@seattlecca.org

    Andrei Shustov
    Principal Investigator

    Vancouver

    Northwest Cancer Specialists at Vancouver Cancer Center

    Susan Papenfuse
    Ph: 360-449-6521
    Email: susan.papenfuse@usoncology.com

    Judith Welch
    Ph: 360-449-6522
    Email: Judith.welch@usoncology.com

    Kathryn Kolibaba, MD
    Principal Investigator

    Yakima

    North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Mark Lapsley
    Ph: 509-574-3493
    Email: mark.lapsley@yvmh.org

    Beth Parker
    Ph: 509-574-3493
    Email: beth.parker@yvmh.org

    Thomas Edwin Boyd
    Principal Investigator

    Canada

    Ontario
    Barrie

    Royal Victoria Regional Health Centre

    Kim Marsh-Gray
    Ph: 705-728-9090Ext. 43340
    Email: marshk@rvh.on.ca

    Michele Harris
    Ph: 705-728-9090Ext. 43342
    Email: harrism@rvh.on.ca

    Derek Nay, MD
    Principal Investigator

    Quebec
    Montreal

    Jewish General Hospital - Montreal

    Cara Lau
    Ph: 514-340-8222Ext. 8325
    Email: clau@jgh.mcgill.ca

    Monica Dobocan
    Ph: 514-340-8222Ext. 8326
    Email: mdobocan@jgh.mcgill.ca

    Sarit Assouline
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01799889
    ClinicalTrials.gov processed this data on May 12, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.