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NCT02712112
A Study of Intermittent Dosing Schedule of Imatinib in Patients With Tyrosine Kinase Inhibitor Refractory GISTs
Phase 2 trial testing Imatinib Mesylate in Gastrointestinal Stromal Tumors (GISTs) in 51 participants. Completed in 15 June 2019.
15 June 2019
Quick facts
| Lead sponsor | Asan Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 16 March 2016 |
| Primary completion | 15 June 2019 |
| Estimated completion | 15 June 2019 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Imatinib Mesylate — full drug profile →
Conditions studied
- Gastrointestinal Stromal Tumors (GISTs) — all drugs for Gastrointestinal Stromal Tumors (GISTs) →
Sponsor
Asan Medical Center
Who can join
19 and older, any sex, with Gastrointestinal Stromal Tumors (GISTs). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Recent preclinical study has suggested a potential possibility that imatinib might promote tumor growth in the presence of secondary resistance mutations \[10\]. This result imply that intermittent dosing schedule of imatinib rechallenge might be better than continuous dosing schedule in terms of controlling tumors harboring secondary resistance mutations. In addition, in these heavily pretreated patients, even mild grade of toxicity may significantly impair quality of life, and intermittent dosing schedule may have an advantage in this context. Therefore, investigators hypothesize that intermittent dosing schedule of imatinib rechallenge might be feasible and effective in patients with TKI-refractory GISTs. This study will assess the feasibility of intermittent imatinib dosing schedule in patients with GISTs who had failures from both imatinib and sunitinib.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02712112
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Imatinib Mesylate
Trials testing the same drug.
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- NCT05385549 — 5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk · Phase 2 · recruiting
- NCT04953052 — A Randomized Study to Investigate the Effect of Intravenous Imatinib on the Amount of Oxygen in the Lungs and Blood of A · Phase 2 · withdrawn
- NCT04416750 — Positioning Imatinib for Pulmonary Arterial Hypertension · Phase 2 · unknown
Other Asan Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02712112 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Asan Medical Center
- Last refreshed: 4 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02712112.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing