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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the appropriate dosing regimens for use in future clinical trials of GS-9820 in subjects with lymphoid malignancies.
Arnon P Kater, MD
Academic Medical Center, University of Amsterdam
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)