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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


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

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Trial Information

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


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
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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate

Outcome Description:

Objective response rate (ORR) as assessed by the Independent Review Committee (IRC), defined as the subjects' best overall response during GS-9973/idelalisib therapy and will include complete response (CR) or partial response (PR) (or very good partial response [VGPR] or minor response [MR] for subjects with LPL/WM)

Outcome Time Frame:

up to 48 weeks

Safety Issue:

No

Principal Investigator

Michael Hawkins, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences

Authority:

United States: Food and Drug Administration

Study ID:

GS-US-339-0103

NCT ID:

NCT01796470

Start Date:

April 2013

Completion Date:

April 2016

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Mantle Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Indolent Non-Hodgkin's Lymphoma
  • GS-US-339-0103
  • SYK inhibitor
  • PI3K inhibitor
  • GS-9973
  • GS 9973
  • GS-1101
  • GS 1101
  • Cal-101
  • Cal 101
  • idelalisib
  • leukemia
  • lymphoma
  • CLL
  • MCL
  • DLBCL
  • 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

Name

Location

Cancer Center of Santa BarbaraSanta Barbara, California  93105
Charleston Hematology OncologyCharleston, South Carolina  29403
Northwest Medical SpecialtiesTacoma, Washington  98405
Medical and Surgical Specialists, LLCGalesburg, Illinois  61401
Ventura County Hematology Oncology SpecialistsOxnard, California  93030
Collaborative Research Group LLCBoynton Beach, Florida  33435