A Phase 2 interventional study of Velzatinib in Gastrointestinal Neoplasms, sponsored by GlaxoSmithKline. Recruiting at 3 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
Among 20 studies in Gastrointestinal Stromal Tumors with a site in Japan — 6 open to participants now, 8 under way, 2 of them phase 3. Gastrointestinal Stromal Tumors · Japan.
Among the 20 studies in Gastrointestinal Stromal Tumors with a site in Japan, this one is the 15th largest by planned enrollment of the 19 interventional ones that give a count, is one of 3 that started in 2026, is one of 7 in phase 2, and was the 20th registered.
343 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 61 are open to participants now.
Browse Gastrointestinal Stromal Tumors studies →6 of the 20 studies in Gastrointestinal Stromal Tumors with a site in Japan are open now. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Japan, United States, Argentina and 17 more countries
Ages 18+
Ono Pharmaceutical Co., Ltd. · Sites in Japan
Ages 18+
GlaxoSmithKline · Sites in Japan, United States, Australia and 16 more countries
Ages 18+
Bayer · Sites in Japan, United States, Australia and 8 more countries
Ages 18+
Chinese University of Hong Kong · Sites in Japan, China, Hong Kong and 1 more country
Ages 18–75
A study can be open while its sites in Japan have not opened yet or have stopped. Only those recruiting at a site in Japan →
Of the 49 Gastrointestinal Stromal Tumors studies recruiting now, 38 (78%) set no upper age limit and 4 (8%) stop at 75 or younger; 6 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 8 · Phase 3 4 · Phase 4 1
First in 2004; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 50 across 252 interventional studies indexed under Gastrointestinal Stromal Tumors.
Median enrollment 78 across the 19 interventional studies, 72 across the 1 observational. Of the 12 that completed or were terminated, 6 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 20 have an industry lead sponsor. The 10 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
GlaxoSmithKline has 6 studies filed under Gastrointestinal Stromal Tumors — fewer than ten, so there is no comparison to draw.
3 of the studies in Gastrointestinal Stromal Tumors with a site in Japan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05245968Taiho Pharmaceutical Co., Ltd.A Study of Pimitespib in Combination With Imatinib in Patients With GIST (CHAPTER-GIST-101) | 2026-12 |
| NCT05489237IDRX, Inc., a wholly owned subsidiary of GSK, LLCFirst-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors | 2027-03-10 |
| NCT07689201GlaxoSmithKlineA Study of Velzatinib in Participants With Metastatic and/or Unresectable GIST After Imatinib, Sunitinib, Regorafenib, and Pimitespib | 2027-11-29 |
Add all 3 to your calendar (.ics) → With an account.
Among the 20 studies in Gastrointestinal Stromal Tumors with a site in Japan, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
343 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 61 are open to participants now.
This study's planned enrollment of 24 is below the median of 50 across 252 interventional studies indexed under Gastrointestinal Stromal Tumors.
Browse Gastrointestinal Stromal Tumors studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Compared within Gastrointestinal Stromal Tumors, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gastrointestinal Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Velzatinib
Velzatinib will be administered.
Also known as: GSK6042981
Confirmed 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.
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
Plan to share: No — GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Nov 2027, 15 months after the start.
Of 47 phase 2 interventional studies under Gastrointestinal Stromal Tumors, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 92. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: IDRX-42
Gastrointestinal Stromal Tumors →