Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Diffuse Large B-cell Lymphoma, Indolent Non-Hodgkin's Lymphoma

Thank you

Trial Information

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

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 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

- 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

- Ongoing immunosuppressive therapy

- Concurrent participation in an investigational drug trial with therapeutic intent

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

PFS will be evaluated from date of enrollment until the date of first documented progression or date of death from any cause, whichever were to occur first.

Outcome Time Frame:

up to 48 weeks

Safety Issue:


Principal Investigator

Michael Hawkins, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

June 2015

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Mantle Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Indolent Non-Hodgkin's Lymphoma
  • GS-US-339-0102
  • SYK inhibitor
  • GS-9973
  • GS 9973
  • CLL
  • leukemia
  • lymphoma
  • MCL
  • iNHL
  • FL
  • MZL
  • LPL
  • SLL
  • WM
  • Waldenström's macroglobulinemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Hematologic Neoplasms



Arizona Oncology AssociatesTucson, Arizona  85712-2254
Hematology Oncology Associates of Northern New JerseyMorristown, New Jersey  07960
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
Minnesota Oncology Hematology, PAMinneapolis, Minnesota  55404
Northwest Cancer Specialists, PCVancouver, Washington  98684
Cancer Care Network of South TexasSan Antonio, Texas  78229
Rocky Mountain Cancer Centers, LLPDenver, Colorado  80218
Texas Oncology-Austin MidtownAustin, Texas  78705
Cancer Center of Central ConnecticutSouthington, Connecticut  
Columbia Basin Hematology and OncologyKennewick, Washington  99336
Hattiesburg ClinicHattiesburg, Mississippi  39401
Virginia Cancer Specialists, PCFairfax, Virginia  22031
Yakima Valley Memorial Hospital North Star LodgeYakima, Washington  98902
Illinois Cancer SpecialistsNiles, Illinois  60714
Texas Oncology-Medical City DallasDallas, Texas  75230-2510
Oncology Hematology West PC dba Nebraska Cancer SpecialistsOmaha, Nebraska  68130
Williamette Valley Cancer Center and Research InstituteSpringfield, Oregon  97477
Prairie Lakes Health Care System, Inc.Watertown, South Dakota  57201
Jones Clinic PCGermantown, Tennessee  38138