Drugs / Amrubicin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | small cell lung carcinoma | 2012-08-21 | “it has submitted an imported drug registration application in China for anticancer antibiotic amrubicin HCI” sumitomo-pharma.com ↗ |
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT00915083 | Jun 2009 → May 2011 | cancer | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT00890955 | Mar 2009 → Jul 2010 | lung cancer | Lawrence Einhorn | Completed | No outcome recorded |
| Phase 1 | NCT00132054 | May 2004 → Dec 2006 | small cell lung carcinoma | Japan Multinational Trial Organization | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT01355705 | Aug 2011 → Jul 2016 | plasma cell myeloma | Michaela Liedtke | Completed | No outcome recorded |
| Phase 1/2 | NCT01033032 | Dec 2009 → Jul 2013 | breast cancer | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT03253068 | Aug 2017 → Dec 2020 | small cell lung carcinoma | Wakayama Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT01259375 | Sep 2011 → Feb 2016 | soft tissue sarcoma | University of Utah | Completed | No outcome recorded |
| Phase 2 | NCT01364727 | Jun 2011 → Jul 2014 | thymic carcinoma, thymoma | Heather Wakelee | Completed | No outcome recorded |
| Phase 2 | NCT01331824 | Feb 2011 → Jul 2014 | urinary bladder cancer | Matthew Galsky | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01076504 | Dec 2009 → Mar 2012 | small cell lung carcinoma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00375193 | Nov 2006 → May 2008 | small cell lung carcinoma | Celgene Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00388960 | Nov 2006 → Apr 2010 | small cell lung carcinoma | Celgene Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00319969 | Apr 2006 → Jul 2008 | small cell lung carcinoma | Celgene Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00380835 | ? → Dec 2007 | breast cancer | Celgene Corporation | Withdrawn | No outcome recorded |
| Phase 35 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT06801834 | Apr 2025 → Oct 2029 expected | small cell lung carcinoma | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 3 | NCT01207011 | Oct 2010 → Jun 2014 | lung cancer | Sumitomo Pharma Co., Ltd. | Completed | Missed primary |
| Phase 3 | NCT00660504 | Apr 2008 → Feb 2012 | lung cancer | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT00547651 | Sep 2007 → May 2011 | small cell lung carcinoma | Celgene Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00286169 | Apr 2006 → ? | small cell lung carcinoma | Sumitomo Pharma Co., Ltd. | Terminated | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT01904253 Comparator | Jul 2013 → Jun 2014 | small cell lung carcinoma | Taiho Oncology, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT07365241 Comparator | Jul 2026 → Sep 2030 expected | small cell lung carcinoma | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT07218146 Comparator | Nov 2025 → Jun 2028 expected | small cell lung carcinoma | Zai Lab (Shanghai) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06203210 Comparator | May 2024 → Apr 2027 expected | small cell lung carcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT05740566 Comparator | May 2023 → Jan 2025 overdue | small cell lung carcinoma | Amgen | Active not recruiting | Met primary |
| Phase 3 | NCT02481830 Comparator | Sep 2015 → Aug 2018 | lung cancer | Bristol-Myers Squibb | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2018-10-12 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Announces Phase 3 CheckMate -331 Study Does Not Meet Primary Endpoint of Overall Survival with Opdivo Versus Chemotherapy in Patients with Previously Treated Relapsed Small Cell Lung Cancer bms.com ↗
The study did not meet its primary endpoint of overall survival (OS) with Opdivo versus chemotherapy. |
| 2012-09-05 | Sumitomo Pharma America, Inc. | Regulatory Dainippon Sumitomo Pharma submits an application for anticancer antibiotic amrubicin HCI (Brand name in Japan: CALSED) in China sumitomo-pharma.com ↗
Dainippon Sumitomo Pharma Co., Ltd. (DSP) (Headquarters: Osaka, Japan; President: Masayo Tada) announces today that it has submitted an imported drug registration application in China for anticancer antibiotic amrubicin HCI (Generic name, Brand name in Japan: CALSED ® ) to the State Food and Drug Administration, P.R. China (SFDA) for the treatment of small cell lung cancer as of August 21, 2012. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-10-12 | Bristol-Myers Squibb | Bristol-Myers Squibb Announces Phase 3 CheckMate -331 Study Does Not Meet Primary Endpoint of Overall Survival with Opdivo Versus Chemotherapy in Patients with Previously Treated Relapsed Small Cell Lung Cancer bms.com ↗ |
| 2012-09-05 | Sumitomo Pharma America, Inc. | Dainippon Sumitomo Pharma submits an application for anticancer antibiotic amrubicin HCI (Brand name in Japan: CALSED) in China sumitomo-pharma.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Amrubicin | “In patients with relapsed SCLC, amrubicin (AMR) is the current standard treatment in Japan.” PMID 34590034 ↗ May 2021 |
| Known as | AMR | “To explore the overall response rate (ORR) per RECIST 1.1 as assessed by investigators in subjects with refractory small cell lung cancer treated with pembrolizumab (Pembro)...” NCT03253068 ↗2“The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the treatment of non-small cell lung cancer (NSCLC).” NCT01207011 ↗ “Amrubicin (AMR) and cyclophosphamide both have single-agent activity in SCLC.” PMID 25503432 ↗ Aug 2017 |
| Known as | AMRUBICIN HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1186894 ↗ |
| Known as | Amrubicina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1186894 ↗ |
| Known as | Amrubicine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1186894 ↗ |
| Known as | Calsed | ChEMBL registry synonym — accepted as the source's own label CHEMBL1186894 ↗ |
| Known as | SM 5887 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1186894 ↗ |
| Action | Inhibit | “It acts primarily as an inhibitor of DNA topoisomerase II” NCT01364727 ↗1“DNA topoisomerase II alpha inhibitor” CHEMBL1186894 ↗ |
| Modality | Small molecule | “Synthetic 9-aminoanthracycline” NCT01259375 ↗ |
| Route | Intravenous | “Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.” NCT00319969 ↗ |
| Target | TOP2A | “DNA topoisomerase II alpha inhibitor” CHEMBL1186894 ↗ |