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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, Treatment18 and overGS-US-339-0102
NCI-2013-01283, 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:

Life expectancy of at least 3 months

Karnofsky performance status of ≥ 60

All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before

the start of study drug

Presence of radiographically measurable lymphadenopathy or extranodal lymphoid

malignancy

Prior treatment for lymphoid malignancy requiring treatment for progressive disease

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

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

Exclusion Criteria:

Concurrent participation in an investigational drug trial with therapeutic intent

Ongoing immunosuppressive therapy

History of prior allogeneic bone marrow progenitor cell or solid organ

transplantation

Pregnancy or breastfeeding

Ongoing alcohol or drug addiction

Ongoing inflammatory bowel disease

Ongoing drug-induced pneumonitis

Ongoing or recent hepatic encephalopathy

Ongoing liver injury

Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of

start of study drug

Current therapy with agents that reduce gastric acidity, including but not limited to

antacids, H2 inhibitors, and proton pump inhibitors

Presence of known intermediate- or high-grade myelodysplastic syndrome

Known active central nervous system or leptomeningeal lymphoma

Known histological transformation from iNHL or CLL to an aggressive form of

non-Hodgkin lymphoma (ie, Richter transformation)

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Gilead

    Trial Sites

    U.S.A.

    Alabama
    Birmingham

    University of Alabama at Birmingham Cancer Center

    Andres Forero-Torres
    Principal Investigator

    California
    Duarte

    City of Hope Comprehensive Cancer Center

    Robert W. Chen
    Principal Investigator

    Michigan
    Detroit

    Barbara Ann Karmanos Cancer Institute

    Jay Yang
    Principal Investigator

    New York
    Bronx

    Albert Einstein College of Medicine

    Ramakrishna Battini
    Principal Investigator

    North Carolina
    Chapel Hill

    University of North Carolina at Chapel Hill

    Steven I. Park
    Principal Investigator

    Ohio
    Cleveland

    Case Comprehensive Cancer Center

    Mitchell Reed Smith
    Principal Investigator

    Columbus

    Ohio State University Comprehensive Cancer Center

    Farrukh Tauseef Awan
    Principal Investigator

    Washington
    Seattle

    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Andrei R. Shustov
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifer NCT01799889

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.