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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
GS-9820 tablets containing 200 mg of GS-9820 administered orally
VU Medical Center (VUmc)
Amsterdam, Netherlands
Academic Medical Center
Amsterdam, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Erasmus MC - Daniel den Hoed Cancer Center
Rotterdam, Netherlands
Maximum tolerated dose (MTD)
MTD will be assessed to determine the appropriate dosing regimens for use in future clinical trials of GS-9820 in subjects with lymphoid malignancies.
Time frame: Up to 4 weeks
Overall safety
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.
Time frame: Up to 5 years
Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC
* 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
Time frame: Baseline to Day 29
Pharmacodynamics to measure changes in the phosphatidylinositol 3-kinase (P13K) delta pathway activation and changes in plasma concentration of disease-associated chemokines and cytokines
Time frame: Baseline to Day 29
Tumor control
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.
Time frame: Up to 5 years
Patient well-being assessed using changes in baseline in HRQL (health related quality of life questionnaire) domain and symptom scores based on the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym)
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Time frame: Up to 5 years
Drug exposure
Drug administration for GS-9820 as assessed by prescribing records and GS-9820 compliance as assessed by quantification of used and unused drug.
Time frame: Up to 5 years