This study is to determine the appropriate dosing regimen of GS-9820 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.
Name: GS-9820
Description: GS-9820 tablets containing 200 mg of GS-9820 administered orallyType: DrugGS-9820
Description: MTD will be assessed to determine the appropriate dosing regimens for use in future clinical trials of GS-9820 in subjects with lymphoid malignancies.
Measure: Maximum tolerated dose (MTD) Time: Up to 4 weeksDescription: Overall safety will be assessed by overall safety profile, enumeration and description of any dose-limiting toxicities, serious adverse events, or adverse events leading to discontinuation of study drug.
Measure: Overall safety Time: Up to 5 yearsDescription: Cmax is defined as the maximum concentration of drug Tmax is defined as the time of Cmax Ctrough is defined as the trough concentration AUC is defined as the area under the plasma concentration versus time curve
Measure: Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC Time: Baseline to Day 29Description: Tumor control as assessed by overall response rate (ORR), time to response (TTR), duration of response (DOR), progression-free survival (PFS), percent change in lymph node area, lymph node response rate, splenomegaly response rate, ALC response rate, hepatomegaly response rate, platelet response rate, hemoglobin response rate, and neutrophil response rate.
Measure: Tumor control Time: Up to 5 yearsDescription: Drug administration for GS-9820 as assessed by prescribing records and GS-9820 compliance as assessed by quantification of used and unused drug.
Measure: Drug exposure Time: Up to 5 yearsSingle Group Assignment
There is one SNP
Pharmacodynamics to measure changes in the phosphatidylinositol 3-kinase (P13K) delta pathway activation and changes in plasma concentration of disease-associated chemokines and cytokines. --- P13K ---