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A Phase 1b Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GS-9820 Monotherapy and Combination Therapy in Subjects With Lymphoid Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoid Malignancies

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Trial Information

A Phase 1b Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GS-9820 Monotherapy and Combination Therapy in Subjects With Lymphoid Malignancies


This is a Phase 1b, open-label, dose-escalation and expansion study evaluating the safety,
pharmacokinetics, pharmacodynamics, and antitumor activity of GS-9820, administered alone
and in combination with rituximab. The study will be conducted in 3 stages.

Stage 1 will evaluate the safety and pharmacology of a range of GS-9820 doses. Stage 2 will
assess the safety and pharmacology of GS-9820 in combination with rituximab. Stage 3 will
further explore the safety, pharmacology and clinical activity of GS-9820 monotherapy.


Inclusion Criteria:



- Previously treated recurrent B-cell iNHL, DLBCL, MCL, HL or CLL

- Measurable lymphadenopathy

- Requires therapy

Exclusion Criteria:

- Recent history of a major non-lymphoid malignancy

- Evidence of ongoing infection

- Concurrent participation in another therapeutic clinical trial

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dosing Regimen

Outcome Description:

To determine the appropriate dosing regimens for use in future clinical trials of GS-9820 in subjects with lymphoid malignancies.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Arnon P Kater, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Academic Medical Center, University of Amsterdam

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

GS-US-315-0102

NCT ID:

NCT01705847

Start Date:

November 2012

Completion Date:

March 2015

Related Keywords:

  • Lymphoid Malignancies
  • chronic lymphocytic leukemia (CLL)
  • non-Hodgkin lymphoma (NHL)
  • Hodgkin lymphoma (HL)
  • indolent non-Hodgkin lymphoma (iNHL)
  • diffuse large B-cell lymphoma-activated B-cell (DLBCL-ABC)
  • DLBCL-germinal center B-cell (GCB)
  • mantle cell lymphoma (MCL)
  • GS-9820
  • phosphatidylinositol 3-kinase (PI3K)
  • Neoplasms

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