Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies



Status:Active, not recruiting
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2013
End Date:March 2016

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A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Combination With Idelalisib in Subjects With Relapsed or Refractory Hematologic Malignancies

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


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 or Phase 4 protocols studying idelalisib
(Zydelig®; GS-1101); subjects with malignancies being studied in these protocols must
have failed screening and be registered as a screen failure in the respective
idelalisib protocol

- Prior treatment for lymphoid malignancy

- Presence of radiographically measurable lymphadenopathy or extranodal lymphoid
malignancy

- Discontinuation of all therapy for the treatment of cancer ≥ 3 weeks before the start
of study drug

- 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
We found this trial at
18
sites
Houston, Texas 77030
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Boynton Beach, Florida 33435
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Boynton Beach, FL
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Charleston, South Carolina 29403
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Charleston, SC
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Charleston, South Carolina 29425
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Charleston, SC
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Greenbrae, California 94904
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Greenbrae, CA
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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La Jolla, CA
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Long Beach, California 90813
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Long Beach, CA
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Middletown, OH
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Mount Sterling, Kentucky 40353
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Mount Sterling, KY
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University School of Medicine NYU School of Medicine has a proud history that...
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New York, NY
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New York, New York 10021
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New York, NY
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Oxnard, CA
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Rochester, NY
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Salt Lake City, Utah 84106
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Salt Lake City, UT
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Santa Barbara, California 93105
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Santa Barbara, CA
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Tacoma, Washington 98405
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Tacoma, WA
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Washington,
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