The goal of this clinical study is to learn more about the study drug GS-1206, including its safety, tolerability, and antitumor activity in adult participants with solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
302
Administered Orally
START Midwest, LLC
Grand Rapids, Michigan, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGNEXT Oncology Dallas
Texas City, Texas, United States
RECRUITINGPercentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
Time frame: First dose up to 21 days post first dose
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Time frame: First dose date up to 30 days post last dose (Up to 3 years)
Percentage of Participants Experiencing Clinical Laboratory Abnormalities Based National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Time frame: First dose date up to 30 days post last dose (Up to 3 years)
Plasma Concentrations of GS-1206 and its Metabolites After Single Dose and Repeated Dose Administration
Time frame: Predose and postdose up to end of treatment (up to 2 years)
Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites
Cmax is defined as the maximum observed concentration of drug
Time frame: Up to 2 years
PK Parameter: Tmax of GS-1206 and its Metabolites
Tmax is defined as the time (observed time point) of Cmax
Time frame: Up to 2 years
PK Parameter: AUC0-24h of GS-1206 and its Metabolites
AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24
Time frame: Up to 2 years
Objective Response Rate (ORR)
Gilead Clinical Study Information Center
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START San Antonio, LLC
Texas City, Texas, United States
RECRUITINGORR is defined as the percentage of participants who have measurable disease at baseline and have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and assessed by the investigator at the local site.
Time frame: Up to 3 years
Duration of Response (DOR)
DOR is defined as the measurement from the time of first response (CR or PR) as assessed by the investigator at local site, per RECIST v1.1 until the date of first documented disease progression or death, whichever occurs first.
Time frame: Up to 3 years
Best Overall Response (BOR)
BOR is defined as the best response recorded from first dosing date until disease progression identified by RECIST v1.1, death, or the participant discontinues study treatment, whichever occurs first.
Time frame: Up to 3 years
Progression-Free Survival (PFS)
PFS is defined as the time from first dosing date until disease progression or death from any cause, whichever comes first as measured per RECIST v1.1.
Time frame: Up to 3 years
Disease Control Rate (DCR)
DCR is defined as the measurement by the percentage of participants who achieve confirmed response of CR or PR or stable disease.
Time frame: Up to 3 years