Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Conditions
Brief summary
Dual endpoints: ● OS, defined as the time from the date of randomization until the documented date of death from any cause ● PFS, defined as the time from the date of randomization until the date of radiographic disease progression (per RECIST V1.1 by BICR) or death from any cause, whichever is earlier
Detailed description
● ORR per RECIST V1.1 by BICR ● DCR per RECIST V1.1 by BICR ● DOR per RECIST V1.1 by BICR, PFS per RECIST V1.1 by investigator assessment, ● ORR per RECIST V1.1 by investigator assessment ● DCR per RECIST V1.1 by investigator assessment ● DOR per RECIST V1.1 by investigator assessment, Safety and tolerability as evaluated by the following: AEs/SAEs, clinical laboratory tests, vital signs, ECGs, and ECOG performance status, Serum concentrations of ASP2138: Ctrough, Participant-reported symptomatic AEs using: ● FACIT-GP5 ● PRO-CTCAE, HRQoL using additional parameters as measured by EORTC QLQ-C30, EORTC QLQ-OG25 and EQ-5D-5L questionnaires, Frequency of ADA-positive participants against ASP2138
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dual endpoints: ● OS, defined as the time from the date of randomization until the documented date of death from any cause ● PFS, defined as the time from the date of randomization until the date of radiographic disease progression (per RECIST V1.1 by BICR) or death from any cause, whichever is earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| ● ORR per RECIST V1.1 by BICR ● DCR per RECIST V1.1 by BICR ● DOR per RECIST V1.1 by BICR, PFS per RECIST V1.1 by investigator assessment, ● ORR per RECIST V1.1 by investigator assessment ● DCR per RECIST V1.1 by investigator assessment ● DOR per RECIST V1.1 by investigator assessment, Safety and tolerability as evaluated by the following: AEs/SAEs, clinical laboratory tests, vital signs, ECGs, and ECOG performance status, Serum concentrations of ASP2138: Ctrough, Participant-reported symptomatic AEs using: ● FACIT-GP5 ● PRO-CTCAE, HRQoL using additional parameters as measured by EORTC QLQ-C30, EORTC QLQ-OG25 and EQ-5D-5L questionnaires, Frequency of ADA-positive participants against ASP2138 | — |