Drugs / GDC-0917
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | primary organ-specific lymphoma | — | “In November 2013, CUDC-427's Phase 1 study in patients with solid tumors or lymphoma was placed on partial clinical hold” curis.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01908413 | Jul 2013 → Mar 2015 | lymphoma | Curis, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT01226277 | Oct 2010 → Sep 2012 | — | Genentech, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2015-04-22 | Curis, Inc. | Results Curis Presents Preclinical Data on CUDC-427 at AACR Annual Meeting curis.com ↗
Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, announced today data presented from in vitro and in vivo studies for CUDC-427, an antagonist of inhibitor of apoptosis (IAP) proteins, at the American Association for Cancer Research (AACR) 2015 Annual Meeting. |
| 2014-04-07 | Curis, Inc. | Results Curis Reports CUDC-907 and CUDC-427 Data at AACR Annual Meeting 2014 curis.com ↗
today announced that it reported data from in vitro studies and a translational biomarker analysis for CUDC-907, a dual histone deacytelase (HDAC) and phosphoinositide 3-kinase (PI3K) inhibitor, as well as results from in vitro and in vivo studies for CUDC-427 |
| 2014-03-31 | Curis, Inc. | Regulatory Curis Announces Removal of FDA Partial Clinical Hold on CUDC-427 curis.com ↗
The FDA also indicated that detailed official correspondence regarding the determination will be released in the near future. |
| 2013-11-05 | Curis, Inc. | Regulatory Curis Reports Third Quarter 2013 Financial Results and Provides CUDC-427 Development Update curis.com ↗
The Company expects to respond to the FDA's requests for additional information and also plans to submit an amendment to the current protocol in a timely manner. |
| 2013-06-03 | Curis, Inc. | Results Curis Announces CUDC-427 (GDC-0917) Phase I Clinical Data Presented at ASCO 2013 Annual Meeting curis.com ↗ |
All press releases naming this drug 10 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GDC-0917 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01226277 ↗ |
| Known as | CUDC-427 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01908413 ↗ |
| Action | Inhibit | “CUDC-427 is a drug that is designed to antagonize proteins that prevent or interfere with cell death.” NCT01908413 ↗ |
| Modality | Small molecule | — CHEMBL4297282 ↗ |
| Route | Oral | “Oral repeating dose” NCT01226277 ↗ |