This study will evaluate the safety and tolerability of GS-9901 monotherapy in adults with follicular lymphoma (FL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL). The study will also characterize the pharmacokinetic (PK) profile of GS-9901, determine the appropriate dosing regimen of GS-9901 for use in future clinical trials, and to evaluate the efficacy of GS-9901 monotherapy in adults with FL, MZL, CLL, or SLL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
GS-9901 tablets administered orally
City of Hope
Duarte, California, United States
Cancer Care Center of Fresno
Fresno, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Cancer Center Central Connecticut
Southington, Connecticut, United States
Lombardi Cancer Center-Georgetown University
Washington D.C., District of Columbia, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Occurrence of adverse events (AEs) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)
Overall safety profile will be characterized by number of participants experiencing adverse events or laboratory abnormalities.
Time frame: Up to 28 days
Occurrence of AEs and clinical laboratory abnormalities not defined as DLTs
Overall safety profile will be characterized by number of participants experiencing adverse events or laboratory abnormalities.
Time frame: Up to 2 years
Overall response rate
Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).
Time frame: Up to 2 years
Progression-free survival
Progression-free survival (PFS) is defined as the interval from the start of study therapy to the earlier of the first documentation of definitive disease progression or death from any cause.
Time frame: Up to 2 years
Duration of response
Duration of response (DOR) is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause.
Time frame: Up to 2 years
PK profile of GS-9901
This endpoint will measure the plasma PK profile of GS-9901. The following parameters will be measured: * Cmax: maximum observed concentration of drug in plasma * AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)
Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, and 24 hours postdose on Days 1 and 15; predose and 1.5 hours postdose on Days 29, 43, 85, and 169
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