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Clinical Trials (PDQ®)

A Phase 2 of GS-9973 in Subjects With Relapsed or Refractory Hematologic Malignancies

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

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 GS-9973. Up to 280 participants will be enrolled who have one of the following hematological tumor types: 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
  • 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 NHL (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

Alma Araneta
  Email: alma.araneta@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-TorresPrincipal 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, MDPrincipal Investigator
California
  Duarte
 City of Hope Comprehensive Cancer Center
 Jaemee Bautista Ph: 626-256-4673 Ext.63033
  Email: jbautista@coh.org
 Pennie Lam Ph: 626-256-4673 Ext.63192
  Email: hilam@coh.org
 Robert Chen, MDPrincipal 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, MDPrincipal 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, MDPrincipal Investigator
Connecticut
  Southington
 Cancer Center of Central Connecticut - Southington
 Mark Turney Ph: 860-621-9316
  Email: mjt2716@sbcglobal.net
 Peter D. ByeffPrincipal 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, MDPrincipal Investigator
  Hollywood
 Memorial Cancer Institute at Memorial Regional Hospital
 Deneise Francis Ph: 954-965-6390
  Email: Dfrancis@mhs.net
 Alvaro Alencar, MDPrincipal 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, MDPrincipal Investigator
Georgia
  Atlanta
 Northside Hospital
 Robin Williams Ph: 770-496-9419
  Email: Robin.Williams@gacancer.com
 Charles Sykes Ph: 478-745-6130 Ext.x128
  Email: charles.sykes@gacancer.com
 Mansoor Noorali SalehPrincipal Investigator
  Lawrenceville
 Gwinnett Hospital System Dba The Center for Cancer Care
 Kathy Frank Ph: 678-533-1567
  Email: kfrank@suburban-hemonc.com
 Christopher Hagenstad, MDPrincipal 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. HermannPrincipal 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, MDPrincipal 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, MDPrincipal 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 KleinPrincipal Investigator
Michigan
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
 Tina Willbee Ph: 734-936-3879
  Email: tpelton@med.umich.edu
 Erica Chapman Ph: 734-232-0716
  Email: echapman@med.umich.edu
 Daniel Lebovic, MDPrincipal 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, MDPrincipal 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, MDPrincipal Investigator
Mississippi
  Hattiesburg
 Hattiesburg Clinic, PA at Forrest General
 Tammy McBeth Ph: 601-288-2495
  Email: tmcbeth@forrestgeneral.com
 John Hrom, MDPrincipal 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, MDPrincipal Investigator
New Jersey
  Morristown
 Hematology-Oncology Associates of Northern New Jersey, PA at Carol G. Simon Cancer Center
 Michelle MacKenzie Ph: 973-538-3593 Ext.2338
  Email: mmackenzie@hoannj.com
 Charles M. FarberPrincipal Investigator
Ohio
  Cincinnati
 Oncology Hematology Care, Incorporated - Blue Ash
 Nicole Given Ph: 513-751-2273 Ext.27110
  Email: ngiven@ohcare.com
 Shaundra Izzo Ph: 513-751-2273
  Email: sizzo@ohcare.com
 James Essell, MDPrincipal 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, MDPrincipal 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, MDPrincipal 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, MDPrincipal Investigator
Tennessee
  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 JonesPrincipal Investigator
  Nashville
 Tennessee Oncology, PLLC - Baptist Medical Building
 Sara Colding Ph: 615-524-4127
  Email: sara.colding@scresearch.net
 Ian Flinn, MD, PhDPrincipal Investigator
Texas
  Arlington
 Arlington Cancer Center - Arlington
 Nikki Rogers Ph: 817-261-4906
  Email: nikkirogers@texashealth.org
 Alfred DiStefano, MDPrincipal 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, MDPrincipal 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, MDPrincipal 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, PhDPrincipal Investigator
  San Antonio
 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, MDPrincipal 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, MDPrincipal Investigator
  Richmond
 Virginia Cancer Institute - West End
 David Nilson Ph: 804-288-7159
  Email: dnilson@vacancer.com
 James Khatcheressian, MDPrincipal Investigator
Washington
  Kennewick
 Columbia Basin Hematology
 Heather Johansen, MD Ph: 509-783-4637 Ext.1
  Email: hjohansen@cbho.org
 Dina Kasper Ph: (509) 783-4637
  Email: dkasper@cbho.org
 Thomas Rado, MDPrincipal 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, MDPrincipal 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, MDPrincipal 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 BoydPrincipal Investigator
Canada
Ontario
  Barrie
 Royal Victoria Regional Health Centre
 Kim Marsh-Gray Ph: 705-728-9090 Ext.43340
  Email: marshk@rvh.on.ca
 Michele Harris Ph: 705-728-9090 Ext.43342
  Email: harrism@rvh.on.ca
 Derek Nay, MDPrincipal Investigator
Quebec
  Montreal
 Sir Mortimer B. Davis-Jewish General Hospital
 Cara Lau Ph: 514-340-8222 Ext.8325
  Email: clau@jgh.mcgill.ca
 Monica Dobocan Ph: 514-340-8222 Ext.8326
  Email: mdobocan@jgh.mcgill.ca
 Sarit AssoulinePrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01799889
ClinicalTrials.gov processed this data on May 11, 2014

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.

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