Drugs / Poziotinib
Poziotinib
also known as
HM781-36B · NOV120101 · HM 781-36 · HM-781-36B hydrochloride · NOV-1201 · Poziotinib Hydrochloride
Small molecule targets EGFR via inhibition
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT04981704 | Apr → Jun 2021 | — | Spectrum Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT04436562 | May → Jul 2020 | — | Spectrum Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT03804515 | Jun 2019 → Feb 2020 | cancer | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 1 | NCT03429101 | Jul 2018 → Apr 2019 | female breast carcinoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 1 | NCT01455584 | Jun 2011 → May 2013 | high grade malignant neoplasm | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT01455571 | Nov 2009 → Jan 2013 | neoplasm | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04402008 | Jun 2020 → Feb 2023 | non-small cell lung carcinoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT01746771 | Nov 2012 → Aug 2015 | carcinoma | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 215 trials · 1 met primary | ||||||
| Phase 2 | NCT05045404 | Jun 2021 → Feb 2023 | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04172597 | Dec 2019 → Mar 2022 | breast cancer, colorectal cancer, glioblastoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04044170 | Jul 2019 → Apr 2020 | non-small cell lung carcinoma | Hanmi Pharmaceutical Company Limited | Terminated | No outcome recorded |
| Phase 2 | NCT03770988 | Apr 2019 → Aug 2020 | esophageal squamous cell carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT03744715 | Oct 2018 → Mar 2023 | breast cancer, non-small cell lung carcinoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03318939 | Oct 2017 → Apr 2023 | non-small cell lung carcinoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03292250 | Sep 2017 → Mar 2020 | head and neck squamous cell carcinoma | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03066206 | Mar 2017 → Feb 2026 | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Terminated | Met primary |
| Phase 2 | NCT02979821 | Oct 2016 → Dec 2017 | lung adenocarcinoma | Korean Association for the Study of Targeted Therapy | Completed | No outcome recorded |
| Phase 2 | NCT02659514 | Feb 2016 → Mar 2020 | breast cancer | Spectrum Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 2 | NCT02544997 | Sep 2015 → Feb 2020 | breast cancer | Samsung Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02418689 | Apr 2015 → Jun 2017 | breast cancer | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 2 | NCT02216916 | Aug 2014 → Jul 2019 | head and neck squamous cell carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT01819428 | Mar 2013 → Nov 2015 | lung adenocarcinoma | National OncoVenture | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01718847 | Jan 2013 → Sep 2014 | — | National OncoVenture | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05378763 | May 2022 → Dec 2027 | non-small cell lung carcinoma | Spectrum Pharmaceuticals, Inc | Suspended | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2015-11-23 | Hanmi Pharmaceutical Company Limited | Regulatory <보도자료> 다중표적 항암신약, 유방암 美 2상 본격화 hanmi.co.kr ↗
한미약품(대표이사 이관순, www.hanmi.co.kr)은 포지오티닙의 글로벌 판권(중국-한국 제외)을 확보한 스펙트럼社가 최근 미국 FDA에 유방암 환자 대상의 임상2상 승인을 신청했다고 23일 밝혔다. |
| 2015-02-27 | Hanmi Pharmaceutical Company Limited | Regulatory Targeted anti-cancer agents Poziotinib, goes on phase 2 to expand indications for Breast cancer hanmipharm.com ↗
Hanmi Pharm recently revealed that Hanmi has approved by MFDS (Ministry of Food and Drug Safety) for conducting phase 2 clinical trials to stage 4 breast cancer patients by using Poziotinib. |
| 2015-02-26 | Hanmi Pharmaceutical Company Limited | Regulatory <보도자료> 표적항암제 포지오티닙, 유방암 2상…적응증 확대 hanmi.co.kr ↗
한미약품과 항암신약개발사업단은 최근 식약처로부터 포지오티닙에 대한 4기 유방암 환자 대상 2상 임상시험을 승인 받고, 삼성서울병원 등 국내 7개 기관에서 두 가지 이상의 HER-2 표적 항암요법에 실패한 유방암 환자 70여명을 대상으로 임상을 시작한다고 26일 밝혔다. |
All press releases naming this drug 8 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Poziotinib | “Poziotinib” NCT02418689 ↗ |
| Known as | HM 781-36 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545154 ↗ |
| Known as | HM-781-36B hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545154 ↗ |
| Known as | HM781-36B | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01455584 ↗ |
| Known as | NOV-1201 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545154 ↗ |
| Known as | NOV120101 | “The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a 2nd line...” NCT01718847 ↗2“NOV120101 (Poziotinib) 12 mg PO once daily for 2 weeks followed by a 1-week drug-free interval between cycles until disease progression or unacceptable toxicity development” NCT02418689 ↗ “NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma” NCT01819428 ↗ |
| Known as | Poziotinib Hydrochloride | “Drug: Poziotinib Hydrochloride” NCT04172597 ↗ |
| Action | Inhibit | “novel pan-HER inhibitor” NCT01718847 ↗ |
| Modality | Small molecule | “many new class of TKIs including NOV120101 (Poziotinib) are developing these days” NCT01819428 ↗ |
| Route | Oral | “following oral administration of HM781-36B” NCT01455571 ↗ |
| Target | EGFR | “EGFR/HER2 inhibitor” NCT03292250 ↗ |