Drugs / Fimepinostat
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03893487 | Aug 2019 → Oct 2022 overdue | anaplastic astrocytoma, diffuse intrinsic pontine glioma, glioblastoma, medulloblastoma | Sabine Mueller, MD, PhD | Active not recruiting | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT02909777 | Oct 2016 → Dec 2025 | brain neoplasm, lymphoma, neuroblastoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02307240 | Nov 2014 → May 2019 | malignant ovarian serous tumor, nut midline carcinoma, triple-negative breast carcinoma | Curis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01742988 | Dec 2012 → Oct 2020 | high grade B-cell lymphoma, high-grade B-cell lymphoma double-hit/triple-hit | Curis, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03002623 | Dec 2016 → Feb 2018 | differentiated thyroid carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT02674750 | Jul 2016 → May 2019 | diffuse large B-cell lymphoma | Curis, Inc. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT05971758 Comparator | Jan 2025 → Jan 2029 expected | Cushing syndrome | University of California, Los Angeles | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2020-03-19 | Curis, Inc. | Results Curis Reports Fourth Quarter and Year-End 2019 Financial Results and Provides Business Update curis.com ↗
Given current market conditions, we have made the decision to discontinue the study and focus our resources on CA-4948 and CI-8993. |
| 2018-05-31 | Curis, Inc. | Regulatory /C O R R E C T I O N -- Curis, Inc./ curis.com ↗
Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative therapeutics for the treatment of cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of fimepinostat |
| 2017-08-03 | Curis, Inc. | Results Curis Reports Second Quarter 2017 Financial Results curis.com ↗
Of the 36 evaluable patients with MYC-altered DLBCL in the interim analysis, 7 patients experienced confirmed durable objective responses (19.4% ORR), including 3 with complete responses. |
| 2016-04-20 | Curis, Inc. | Results Curis and Aurigene Present Preclinical Data from Multiple Programs at AACR Annual Meeting curis.com ↗
Our data show significant effect of CUDC-907 on MYC levels and the compound's antitumor activity in multiple preclinical models of MYC-altered malignancies |
| 2016-04-04 | Curis, Inc. | Results Curis Announces Publication of CUDC-907 Phase 1 Clinical Trial Data in Lancet Oncology curis.com ↗
today announced the publication of results from the dose escalation part of the Phase 1 clinical trial in the journal Lancet Oncology. |
| 2015-12-05 | Curis, Inc. | Results Curis Reports Clinical Activity of CUDC-907 in Patients With DLBCL Harboring MYC Oncogene Alterations at the 2015 ASH Annual Meeting curis.com ↗
In the ongoing Phase 1 trial of CUDC-907, 8 objective responses (3 CRs and 5 PRs) were reported in 18 response-evaluable patients out of a total of 25 patients with RR-DLBCL enrolled in the trial. |
| 2015-05-31 | Curis, Inc. | Results Curis Reports CUDC-907 Data From the Ongoing Phase 1 Trial at the 2015 ASCO Annual Meeting curis.com ↗
At the recommended Phase 2 dose and schedule, CUDC-907 has demonstrated evidence of clinical activity with objective responses observed in patients with relapsed/ refractory diffuse large B cell lymphoma (DLBCL) and Hodgkin's lymphoma (HL). |
| 2015-04-05 | Curis, Inc. | Regulatory Curis Announces Orphan Drug Designation for CUDC-907 in Diffuse Large B-Cell Lymphoma 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 that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead proprietary drug candidate, CUDC-907 for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). |
| 2014-11-10 | Curis, Inc. | Results Curis Reports Third Quarter 2014 Financial Results and Pipeline Update curis.com ↗
Among the 8 disease-evaluable patients with diffuse large B-cell lymphoma (DLBCL) treated with CUDC-907 to date, 7 have experienced tumor shrinkage, including 1 patient with a complete response, 2 with partial responses (i.e., tumor shrinkage greater than 50%), and 4 patients with tumor shrinkage ranging from 5% to 46%. |
| 2014-10-28 | Curis, Inc. | Regulatory Curis Announces Allowance of U.S. Patent Covering Compounds Targeting HDAC and PI3K Activities in a Single Molecule curis.com ↗ |
| 2014-10-02 | Curis, Inc. | Regulatory Curis Announces CUDC-907 Development Program Advancements curis.com ↗
In addition, Curis announced that a second Investigational New Drug (IND) application for CUDC-907 has been accepted by the U.S. Food & Drug Administration and a new study will be initiated under this IND that will enroll patients with advanced solid tumors, including patients with hormone receptor positive breast cancer, among others. |
| 2014-04-07 | Curis, Inc. | Results Curis Reports CUDC-907 and CUDC-427 Data at AACR Annual Meeting 2014 curis.com ↗
The poster presentation included data from cell-based hematologic models suggesting that, in addition to direct effects on cancer cells, CUDC-907 may also alter the tumor microenvironment as measured by changes in the levels of certain cytokines and chemokines. |
| 2013-12-09 | Curis, Inc. | Results Curis Reports CUDC-907 Preliminary Data From the Ongoing Phase 1 Trial at ASH 2013 Annual Meeting curis.com ↗
Intermittent oral dosing of CUDC-907 appears to be better tolerated than continuous daily dosing (QD), which demonstrated preliminary evidence of anti-tumor activity with a partial response (PR) observed in 1 patient. |
| 2013-06-20 | Curis, Inc. | Regulatory Curis Announces U.S. Patent Issuance Strengthening Intellectual Property Position of PI3K-HDAC Inhibitor CUDC-907 curis.com ↗
Curis, Inc. (Nasdaq:CRIS), an oncology-focused drug development company seeking to develop novel drug candidates for the treatment of various cancers, today announced the issuance of U.S. Patent No. 8,461,157, which claims methods of treating human diseases or disorders mediated by one or more of phosphoinositide 3-kinase (PI3K), mammalian target of rapamycin (mTOR) and histone deacetylase (HDAC) proteins, using compounds from a genus of small molecules with dual inhibitory properties, including but not limited to CUDC-907, a proprietary clinical stage dual inhibitor of PI3K and HDAC enzymes. |
All press releases naming this drug 24 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fimepinostat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01742988 ↗ |
| Known as | CUDC-907 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02307240 ↗ |
| Action | Inhibit | “Fimepinostat (CUDC-907) is a multi-targeted agent designed to inhibit phosphoinositide 3-kinase (PI3K)and histone deacetylase (HDAC).” NCT01742988 ↗3“PI3-kinase p110-delta subunit inhibitor” CHEMBL3622533 ↗ “PI3-kinase p110-alpha subunit inhibitor” CHEMBL3622533 ↗ “PI3-kinase p110-beta subunit inhibitor” CHEMBL3622533 ↗ |
| Modality | Small molecule | “Combination HDAC and Pi3-kinase Inhibitor” NCT05971758 ↗ |
| Route | Oral | “administered orally” NCT02307240 ↗ |
| Target | PIK3CA | “PI3-kinase p110-alpha subunit inhibitor” CHEMBL3622533 ↗ |
| Target | PIK3CB | “PI3-kinase p110-beta subunit inhibitor” CHEMBL3622533 ↗ |
| Target | PIK3CD | “PI3-kinase p110-delta subunit inhibitor” CHEMBL3622533 ↗ |