The goal of this study is to evaluate the study drug velzatinib (GSK6042981 / IDRX-42) to see whether velzatinib can shrink or control tumors and is safe and tolerated in Japan participants with gastrointestinal tumors (GIST) who progressed or were intolerant to standard therapies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Velzatinib will be administered.
GSK Investigational Site
Fukuoka, Japan
RECRUITINGGSK Investigational Site
Hokkaido, Japan
RECRUITINGConfirmed objective response rate (ORR)
ORR is defined as the percent of participants reaching confirmed complete response (CR) or partial response (PR).
Time frame: Up to 67 weeks
Duration of response (DOR)
DOR is defined as the time from the date of first documented objective response (confirmed CR or PR) to the date of first documented disease progression (PD) or death due to any cause, whichever comes first.
Time frame: Up to 156 weeks
Disease control rate for minimum 8-week period (DCR8)
DCR8 is defined as the percent of participants reaching confirmed CR or PR, or stable disease (SD) sustained for a minimum period of 8 weeks.
Time frame: Up to 156 weeks
Progression free survival (PFS)
PFS is defined as the time from the date of first dose of study treatment to the date of first documented PD or death due to any cause, whichever comes first.
Time frame: Up to 156 weeks
Overall survival (OS)
OS is defined as the time from the date of first dose of study treatment to the date of death due to any cause.
Time frame: Up to 156 weeks
Confirmed ORR
ORR is defined as the percent of participants reaching confirmed CR or PR.
Time frame: Up to 156 weeks
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-F17 (EORTC-QLQ-F17)
The EORTC QLQ-F17 is a shorter version of the EORTC QLQ-C30. QLQ-F17 includes the Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. Scores for each scale are averaged and transformed linearly to a score ranging from 0-100. A high score for functional scales and for Global Health Status/QoL represents better functioning ability or HRQoL.
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Time frame: Baseline (Day 1) up to 156 weeks
Change from baseline in EQ-5D-5L score
The EQ-5D-5L is a validated standardised, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: Baseline (Day 1) up to 156 weeks
Plasma concentrations of velzatinib
Time frame: Up to 156 weeks
Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), dose reductions and interruptions and discontinuation of study treatment due to toxicity by severity
Time frame: Up to 156 weeks