Gastrointestinal Neoplasms
Conditions
Keywords
Velzatinib, GSK6042981, IDRX-42, Gastrointestinal Stromal Tumors (GIST)
Brief summary
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.
Interventions
DRUGVelzatinib
Velzatinib will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable. * Documented disease progression on or intolerance to imatinib, sunitinib, regorafenib, and pimitespib. * Documented mutation status of KIT and/or PDGFRA. * Tumor tissue may be available for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Investigators may consult with the sponsor regarding the enrolment of participants for whom archival tissue is no longer available and who are not eligible to undergo a new biopsy. * Is willing to use adequate contraception male and/or female participants.
Exclusion criteria
* Known untreated or active central nervous system metastases. * Has significant, uncontrolled, or active cardiovascular disease. * Participants with a known allergy or hypersensitivity to any component of velzatinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded. * Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of metastatic disease. * Prior treatment with ripretinib or other investigational agents that are currently under clinical development for GIST. * Is pregnant or breastfeeding. * Any condition or illness that, in the opinion of the Investigator, might compromise participant safety or interfere with the evaluation of the safety of the study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmed objective response rate (ORR) | Up to 67 weeks | ORR is defined as the percent of participants reaching confirmed complete response (CR) or partial response (PR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | Up to 156 weeks | 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. |
| Disease control rate for minimum 8-week period (DCR8) | Up to 156 weeks | 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. |
| Progression free survival (PFS) | Up to 156 weeks | 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. |
| Overall survival (OS) | Up to 156 weeks | OS is defined as the time from the date of first dose of study treatment to the date of death due to any cause. |
| Confirmed ORR | Up to 156 weeks | ORR is defined as the percent of participants reaching confirmed CR or PR. |
| Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-F17 (EORTC-QLQ-F17) | Baseline (Day 1) up to 156 weeks | 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. |
| Change from baseline in EQ-5D-5L score | Baseline (Day 1) up to 156 weeks | 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). |
| Plasma concentrations of velzatinib | 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 | Up to 156 weeks | — |
Countries
Japan
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
Outcome results
None listed