Drugs / NUC-1031
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02303912 | Nov 2014 → Jan 2017 | ovarian cancer | Imperial College Healthcare NHS Trust | Completed | No outcome recorded |
| Phase 1 | NCT01621854 | Oct 2012 → Jun 2015 | cancer | Imperial College London | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03146663 | Sep 2017 → Dec 2019 | ovarian cancer | NuCana plc | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04163900 | Dec 2019 → Mar 2022 | biliary tract cancer | NuCana plc | Terminated | Mixed |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2022-03-02 | Nucana | Results NuCana Announces Update for Phase 3 Biliary Tract Cancer Study nucana.com ↗
Although a higher objective response rate, as assessed by Blinded Independent Central Review, was observed in the Acelarin plus cisplatin arm, this did not translate into an overall survival benefit. |
| 2021-09-29 | Nucana | Regulatory NuCana Receives Fast Track Designation from the U.S. Food and Drug Administration for Acelarin® (NUC-1031) for the Treatment of Biliary Tract Cancer nucana.com ↗
NuCana plc (NASDAQ: NCNA) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Acelarin (NUC-1031), currently being evaluated in a Phase III study (NuTide:121) for the first-line treatment of patients with advanced biliary tract cancer. |
| 2021-04-10 | Nucana | Results NuCana Announces Five Poster Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2021 nucana.com ↗
Specifically, the poster described how Acelarin (NUC-1031) is converted to the active anti-cancer metabolite (dFdCTP) and demonstrated that it is incorporated into DNA, inducing persistent double-strand breaks. |
| 2020-11-30 | Nucana | Results Final Data from the Phase Ib Study of Acelarin plus Cisplatin in Patients with Advanced Biliary Tract Cancer Published Online Ahead of Print in The Oncologist nucana.com ↗
NuCana plc (NASDAQ: NCNA) announced that the final results of the Phase Ib study of Acelarin plus cisplatin for patients with advanced biliary tract cancer (ABC-08) have been published online ahead of print in The Oncologist. |
| 2020-05-15 | Nucana | Results NuCana to Present Two Abstracts at the American Association for Cancer Research (AACR) Annual Meeting 2020 nucana.com ↗
Acelarin was found to cause the release of Damage Associated Molecular Patterns, or DAMPs, and increase the expression of PD-L1 on cancer cells. |
| 2020-03-10 | Nucana | Results NuCana Reports Preliminary Data from Phase II Study of Single-Agent Acelarin (NUC-1031) in Patients with Platinum-Resistant Ovarian Cancer nucana.com ↗
Based on an assessment by blinded independent central review, one patient achieved a complete response and two patients achieved partial responses. |
| 2020-03-04 | Nucana | Regulatory NuCana Receives Positive Opinion for Orphan Drug Designation in the European Union for Acelarin (NUC-1031) for the Treatment of Patients with Biliary Tract Cancer nucana.com ↗
NuCana plc (NASDAQ: NCNA) announced that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for orphan drug designation of Acelarin for the treatment of patients with biliary tract cancer. |
| 2019-10-25 | Nucana | Regulatory NuCana Announces FDA Clearance to Commence Phase III Study of Acelarin (NUC-1031) for the First-Line Treatment of Patients with Biliary Tract Cancer nucana.com ↗
NuCana plc (NASDAQ: NCNA) announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for its Phase III study (NuTide:121) of the investigational drug Acelarin in combination with cisplatin for patients with previously untreated locally advanced or metastatic biliary tract cancer. |
| 2019-08-20 | Nucana | Results Enrollment in the Independent Investigator-Sponsored Phase III Metastatic Pancreatic Study ACELARATE Has Been Suspended Following a Prespecified Futility Analysis nucana.com ↗
This analysis indicated that this efficacy objective was unlikely to be met in this difficult to treat patient population. |
| 2019-06-12 | Nucana | Regulatory NuCana Receives Orphan Drug Designation from the U.S. Food and Drug Administration for Acelarin® for the Treatment of Biliary Tract Cancer nucana.com ↗
“We are pleased to have received orphan drug designation from the FDA for Acelarin in biliary tract cancer,” said Hugh Griffith, NuCana’s Founder and Chief Executive Officer. |
| 2018-10-21 | Nucana | Results NuCana Reports Additional Promising Clinical Data on NUC-1031 (Acelarin®) as Front-Line Treatment of Advanced Biliary Tract Cancer at ESMO 2018 nucana.com ↗
In the intent-to-treat group of patients, a Complete Radiological Response was achieved in one patient and a Partial Response in six patients, resulting in an Objective Response Rate of 50%. |
| 2018-01-19 | Nucana | Results NuCana Announces Promising Clinical Data at ASCO GI on NUC-1031 (Acelarin®) as Front-Line Treatment of Advanced Biliary Tract Cancer nucana.com ↗
This analysis of the Phase 1b multi-center, open-label study showed that Acelarin, when combined with cisplatin, achieved high response rates and was well-tolerated in front-line advanced biliary tract cancer. |
| 2017-09-12 | Nucana | Results NuCana Announces Positive Results of NUC-1031 (Acelarin®) in Advanced Ovarian Cancer at ESMO 2017 (6151) nucana.com ↗
Results from NuCana’s Phase 1b trial showed that Acelarin, when combined with carboplatin, was well tolerated and demonstrated clinical activity in women with recurrent platinum-resistant and platinum-sensitive ovarian cancer. |
All press releases naming this drug 14 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NUC-1031 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01621854 ↗ |
| Modality | Small molecule | “NUC-1031, a Nucleotide Analogue, in Patients With Advanced Solid Tumours.” NCT01621854 ↗ |
| Route | Intravenous | “administered IV weekly on days 1, 8, \& 15 (Schedule A) or twice weekly on days 1 \& 5, 8 \& 12, 15 \&19 (Schedule B)” NCT01621854 ↗ |