Drugs / Debio 1347
Debio 1347
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01948297 | Aug 2013 → Jun 2020 | cancer | Debiopharm International SA | Terminated | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03344536 | Nov 2017 → Aug 2021 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03834220 | Mar 2019 → Dec 2020 | cancer | Debiopharm International SA | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2018-05-08 | Debiopharm International SA | Regulatory FDA Grants Fast Track designation to Debiopharm International’s Debio1347 for the treatment of patients with unresectable or metastatic tumors with a specific FGFR gene alteration debiopharm.com ↗ |
| 2017-11-14 | Debiopharm International SA | Regulatory EMA grants Orphan Drug Designation to Debiopharm International SA’s FGFR inhibitor Debio1347 in the treatment of biliary tract cancer debiopharm.com ↗ |
| 2017-06-01 | Debiopharm International SA | Results Debiopharm International SA Announces Results from Phase I Dose-Escalation Study of Debio1347/CH5183284 debiopharm.com ↗
Encouraging antitumor activity was seen in several tumor types, mainly in patients with FGFR2 or 3 gene alterations, including fusion events. |
All press releases naming this drug 7 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Debio1347 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01948297 ↗ |
| Action | Inhibit | “Oral Selective Pan-FGFR Inhibitor Debio 1347” NCT03834220 ↗ |
| Route | Oral | “Debio1347 orally administered daily” NCT01948297 ↗ |
| Target | FGFR1 | “A Phase II Basket Study of the Oral Selective Pan-FGFR Inhibitor Debio 1347 in Subjects With Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3” NCT03834220 ↗ |
| Target | FGFR2 | “A Phase II Basket Study of the Oral Selective Pan-FGFR Inhibitor Debio 1347 in Subjects With Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3” NCT03834220 ↗ |
| Target | FGFR3 | “A Phase II Basket Study of the Oral Selective Pan-FGFR Inhibitor Debio 1347 in Subjects With Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3” NCT03834220 ↗ |