Diseases / Gastrointestinal Stromal Tumors
Gastrointestinal Stromal Tumors
DiseaseGastrointestinal stromal tumors (GISTs) are rare mesenchymal neoplasms of the gastrointestinal tract, commonly driven by activating KIT or PDGFRA mutations and arising from interstitial cells of Cajal. They can occur throughout the GI tract, most often in the stomach and small intestine. Clinical behavior ranges from indolent to malignant, and management depends on tumor risk features and molecular profile.
- Trials
- 333
- Recruiting
- 46
- Completed
- 178
- With results
- 69
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Approved for marketing | Available | No longer available | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | — | 1 | — | — | — | 1 | — | — | — | 2 |
| Phase 1 | 5 | — | — | 2 | 29 | 4 | 1 | 1 | 1 | — | — | — | 43 |
| Phase 1/2 | 2 | — | — | 1 | 14 | 2 | 1 | — | — | — | — | — | 20 |
| Phase 2 | 16 | 2 | 1 | 5 | 66 | 9 | 2 | — | 10 | — | — | — | 111 |
| Phase 2/3 | 1 | — | — | — | 1 | — | — | — | — | — | — | — | 2 |
| Phase 3 | 3 | 1 | — | 2 | 18 | 9 | — | — | 3 | — | — | — | 36 |
| Phase 4 | — | — | — | — | 8 | — | — | — | 2 | — | — | — | 10 |
| Not applicable | 5 | — | — | 1 | 9 | 5 | — | 1 | 11 | — | — | — | 32 |
| Unknown | 14 | 4 | — | 1 | 32 | 2 | 3 | 1 | 12 | 1 | 2 | 5 | 77 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal Stromal Tumors | 2 | 43 | 20 | 111 | 2 | 36 | 10 | 32 | 77 | 333 |
| Sarcoma | — | 8 | 7 | 16 | — | 2 | — | 1 | 4 | 38 |
| Stomach Neoplasms | — | 9 | 4 | 6 | — | 1 | 1 | 7 | 9 | 37 |
| Pancreatic Neoplasms | — | 7 | 3 | 3 | — | 1 | 1 | 5 | 7 | 27 |
| Esophageal Neoplasms | — | 7 | 1 | 2 | — | 1 | 1 | 3 | 7 | 22 |
| Colonic Neoplasms | — | 6 | 3 | 2 | — | 1 | 1 | 2 | 6 | 21 |
| Colorectal Neoplasms | — | 5 | 4 | 4 | — | — | 1 | 5 | 2 | 21 |
| Gastrointestinal Neoplasms | — | 1 | 2 | 6 | — | 2 | 1 | 2 | 7 | 21 |
| Neoplasm Metastasis | — | 3 | 3 | 5 | — | 3 | — | 1 | 6 | 21 |
| Neoplasms | — | 7 | 2 | 6 | — | 2 | 1 | 2 | 1 | 21 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Novartis Pharmaceuticals | 25 | 4 |
| 2 | National Cancer Institute (NCI) | 23 | 3 |
| 3 | Asan Medical Center | 18 | 2 |
| 4 | Deciphera Pharmaceuticals, LLC | 9 | 3 |
| 5 | Pfizer | 9 | 2 |
| 6 | European Organisation for Research and Treatment of Cancer - EORTC | 7 | 3 |
| 7 | M.D. Anderson Cancer Center | 7 | 0 |
| 8 | Bayer | 6 | 1 |
| 9 | Blueprint Medicines Corporation | 5 | 1 |
| 10 | First Affiliated Hospital, Sun Yat-Sen University | 5 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Imatinib Mesylate | 71 |
| 2 | Sunitinib | 31 |
| 3 | regorafenib | 17 |
| 4 | nilotinib | 15 |
| 5 | ripretinib | 13 |
| 6 | avapritinib | 7 |
| 7 | Dasatinib | 5 |
| 8 | Ipilimumab | 5 |
| 9 | Laparoscopy | 5 |
| 10 | 4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one | 4 |
Evidence
- Results reported
- 38.8%69 of 178 completed
- Published
- 13.5%24 of 178 completed
- Primary endpoint met
- 75%6 of 8 analyses
- Median months to report
- 14
Documents disclosed
Trial profile
- Median enrollment
- 57
- Median duration
- 47months
- Countries
- 58
- Study sites
- 3298
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 18
- Phase 1
- 34
- Phase 1/2
- 68
- Phase 2
- 40
- Phase 2/3
- 152
- Phase 3
- 133
- Phase 4
- 56
- Not applicable
- 61
- Unknown
- 100
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Boston | United States | 54 |
| 2 | New York | United States | 42 |
| 3 | Philadelphia | United States | 42 |
| 4 | Seoul | South Korea | 39 |
| 5 | Houston | United States | 37 |
| 6 | Portland | United States | 36 |
| 7 | Lyon | France | 35 |
| 8 | Beijing | China | 31 |
| 9 | Bordeaux | France | 29 |
| 10 | Los Angeles | United States | 27 |
Terminations
- Terminated
- 31
- Withdrawn
- 7
- Suspended
- 3
- Stopped for recruitment
- 4.2%14 of 333 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT05867901 Suspended | Suspended | Enrollment has been temporarily paused pending ethics review and implementation of the revised study protocol. Follow-up of previously enrolled participants is continuing. | 2028-12-31 |
| NCT05080621 Withdrawn | Withdrawn | The Sponsor decided to discontinue this study due to a corporate restructuring intended to prioritize clinical development of select programs. No patients enrolled in this study and no patients received investigational product. | 2027-05-31 |
| NCT04714983 Suspended | Suspended | DNAtrix management decision not based on study design, safety, or site performance. | 2026-12-31 |
| NCT02734823 Withdrawn | Withdrawn | Lack of accrual | 2024-03-14 |
| NCT05160168 Terminated | Terminated | The Sponsor terminated the study due to early dose-limiting toxicities. | 2024-02-02 |
| NCT04000529 Terminated | Terminated | Business reasons | 2024-01-15 |
| NCT04811833 Withdrawn | Withdrawn | The GASTROMO study has been stopped early before enrolling its first patient because the results of our primary endpoint would have been inconsistent. The variability of the leakage rate between all anastomosis included in the study was overly high. | 2023-12-31 |
| NCT02924714 Suspended | Suspended | Slow accrual | 2022-11-30 |
| NCT04879979 Terminated | Terminated | Slow enrollment | 2022-05-04 |
| NCT04409223 Terminated | Terminated | R\&D strategy adjustment | 2022-03-25 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above:
Search all Gastrointestinal Stromal Tumors trials on ClinicalTrials.gov →