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Trial #NCT01799889
Chronic Lymphocytic Leukemia Clinical Trials

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


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects With Relapsed or Refractory Hematologic Malignancies
Study ID: GS-US-339-0102; Source: Gilead Sciences
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Recruiting
Country Multiple Countries
Study type Interventional
Enrollment 420
Start date March 2013
Completion date December 2016
Phase Phase 2
Sponsor Gilead Sciences
Summary:
This study is to evaluate the efficacy, safety, tolerability, and pharmacodynamics of
GS-9973. 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:
Gender: Both
Age: 18 Years - N/A
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
Outcome:
Primary outcome
  • Progression Free Survival
    Progression Free Survival (PFS) is defined as the interval from first dose of GS-9973 to the earlier of the first documentation of definitive disease progression or death from any cause.
    Time frame: Up to 24 weeks
Secondary outcome
  • Duration of response
    Duration of response (DOR) is defined as time from the first response (CR or PR [or VGPR or MR for participants with LPL/WM]) is achieved until the earlier of the first documentation of definitive disease progression or death from any cause.
    Time frame: Up to 4 years
  • Incidence of abnormal laboratory data and adverse events
    This composite endpoint is to assess the safety and tolerability profile of GS-9973. Safety will be assessed by grading of laboratory values and adverse events according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
    Time frame: Up to 4 years
  • Objective response rate
    Objective response rate (ORR) will be determined from the participants' best response during GS-9973 therapy and will include complete response (CR) and partial response (PR) (or very good partial response [VGPR] or minor response [MR] for subjects with LPL/WM).
    Time frame: Up to 4 years
  • Time to response
    Time to response (TTR) is defined as time from the first dose of GS-9973 to the first time the response (CR or PR [or VGPR or MR for subjects with LPL/WM]) is achieved.
    Time frame: Up to 4 years
Contacts:
  • Steve Abella, M.D.; Gilead Sciences (Study Director)
  • Gilead Study Team;
Location Country Status
University of Alabama at Birmingham Birmingham, Alabama United States Recruiting
Arizona Oncology Associates Tucson, Arizona United States Recruiting
Providence Saint Joseph Medical Center Burbank, California United States Withdrawn
City of Hope National Medical Center Duarte, California United States Recruiting
Sharp Memorial Hospital San Diego, California United States Recruiting
Rocky Mountain Cancer Centers, LLP Boulder, Colorado United States Recruiting
Cancer Center of Central Connecticut Southington, Connecticut United States Recruiting
Florida Cancer - Colonial Ft. Myers, Florida United States Recruiting
Memorial Cancer Institute Hollywood, Florida United States Recruiting
Baptist Cancer Institute Jacksonville, Florida United States Recruiting
Northside Hospital Atlanta, Georgia United States Recruiting
Gwinnett Hospital System Dba The Center for Cancer Care Lawrenceville, Georgia United States Recruiting
Northwest Georgia Oncology Center Marietta, Georgia United States Recruiting
Illinois Cancer Specialists Niles, Illinois United States Recruiting
Hematology Oncology Clinic, PLLC Baton Rouge, Louisiana United States Recruiting
Tufts Medical Center Boston, Massachusetts United States Recruiting
University of Michigan Health System Ann Arbor, Michigan United States Recruiting
Karmanos Cancer Institute Detroit, Michigan United States Recruiting
Minnesota Oncology Hematology, PA Woodbury, Minnesota United States Recruiting
Hattiesburg Clinic Hattiesburg, Mississippi United States Recruiting
Oncology Hematology West PC dba Nebraska Cancer Specialists Omaha, Nebraska United States Recruiting
Hematology Oncology Associates of Northern New Jersey Morristown, New Jersey United States Recruiting
Clinical Research Alliance Lake Success, New York United States Recruiting
University of North Carolina Chapel Hill, North Carolina United States Recruiting
Oncology Hematology Care Cincinnati, Ohio United States Recruiting
Cleveland Clinic Cleveland, Ohio United States Recruiting
Williamette Valley Cancer Center and Research Institute Springfield, Oregon United States Recruiting
South Carolina Oncology Associates, PA Columbia, South Carolina United States Withdrawn
Bon Secours Saint Francis Health System Greenville, South Carolina United States Recruiting
Prairie Lakes Health Care System, Inc. Watertown, South Dakota United States Recruiting
Associates in Oncology and Hematology Chattanooga, Tennessee United States Recruiting
Jones Clinic PC Germantown, Tennessee United States Recruiting
Tennessee Oncology, PLLC Nashville, Tennessee United States Recruiting
Arlington Cancer Center Arlington, Texas United States Recruiting
Texas Oncology-Austin Midtown Austin, Texas United States Recruiting
Texas Oncology-Medical City Dallas Dallas, Texas United States Recruiting
Center for Cancer and Blood Disorders Fort Worth, Texas United States Recruiting
Cancer Care Network of South Texas San Antonio, Texas United States Recruiting
Virginia Cancer Specialists, PC Fairfax, Virginia United States Recruiting
Virginia Cancer Institute Richmond, Virginia United States Recruiting
Columbia Basin Hematology and Oncology Kennewick, Washington United States Recruiting
University of Washington Seattle, Washington United States Recruiting
Northwest Cancer Specialists, PC Vancouver, Washington United States Recruiting
Yakima Valley Memorial Hospital North Star Lodge Yakima, Washington United States Recruiting
Royal Victoria Regional Health Centre Barrie, Ontario Canada Recruiting
Sir Mortimer B. Davis-Jewish General Hospital Montreal, Quebec Canada Recruiting
Sponsors:
  • Gilead Sciences - (Lead Sponsor)

Related trials: Terms
  • SLL
  • LPL
  • GS-US-339-0102
  • WM
  • GS 9973
  • FL
  • MCL
  • iNHL
  • GS-9973
  • DLBCL
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