10 completed, 6 terminated, 2 unknown, 1 suspended. 15 Phase 2, 5 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 15 | Completed 7, Terminated 5, Unknown 2, Withdrawn 1 |
| Phase 1 | 5 | Completed 4, Terminated 1 |
| Phase 3 | 1 | Suspended 1 |
Follow HM781-36B: new trials by email Literature Review of HM781-36B trials Research Report on HM781-36B
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations Poziotinib, Docetaxel - NSCLC | Phase 3 | Suspended | Spectrum Pharmaceuticals, Inc | 268 | 2022-05-12 | 2026-10-28 |
| Poziotinib and Ramucirumab for the Treatment of EGFR Exon 20 Mutant Stage IV Non-small Cell Lung Cancer Poziotinib Hydrochloride, 1429757-68-5, HM781-36B, NOV-1201 Hydrochloride, NOV120101 Hydrochloride, Poziotinib HCl, POZIOTINIB HYDROCHLORIDE - Metastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8 | Phase 2 | Withdrawn | M.D. Anderson Cancer Center | 2021-06-16 | 2023-09-13 | |
| A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Participants Poziotinib, Itraconazole, Phenytoin - Healthy | Phase 1 | Completed | Spectrum Pharmaceuticals, Inc | 74 | 2021-04-08 | 2021-09-05 |
| Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation Poziotinib - NSCLC | Phase 2 | Terminated | Hanmi Pharmaceutical Company Limited | 5 | 2019-07-30 | 2020-11-17 |
| A Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC) Treatment with Poziotinib - Inoperable or Recurrent or Metastatic Esophageal Squamous Carcinoma | Phase 2 | Unknown | Yonsei University | 49 | 2019-04-01 | 2019-02-22 |
| A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib Poziotinib - NSCLC, Breast Cancer | Phase 2 | Terminated | Spectrum Pharmaceuticals, Inc | 7 | 2018-10-11 | 2026-07-28 |
| A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer Poziotinib, T-DM1 - Breast Cancer | Phase 1 | Terminated | Spectrum Pharmaceuticals, Inc | 6 | 2018-07-13 | 2021-01-15 |
| Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation Poziotinib - NSCLC | Phase 2 | Terminated | Spectrum Pharmaceuticals, Inc | 648 | 2017-10-11 | 2026-06-12 |
| Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)] BYL719, Poziotinib, Nintedanib - HNSCC, Head and Neck Neoplasms | Phase 2 | Completed | Seoul National University Hospital | 180 | 2017-09-10 | 2022-03-29 |
| Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC Poziotinib - EGFR Exon 20 Mutation, ERBB2 Gene Mutation | Phase 2 | Terminated | M.D. Anderson Cancer Center | 93 | 2017-03-17 | 2026-02-20 |
| Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001) Poziotinib - HER2 Gene Mutation, Adenocarcinoma Lung Stage IV | Phase 2 | Completed | Korean Association for the Study of Targeted Therapy | 6 | 2016-10-01 | 2018-05-24 |
| Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer Poziotinib - Breast Cancer | Phase 2 | Completed | Spectrum Pharmaceuticals, Inc | 67 | 2016-02-22 | 2022-03-11 |
| A Phase II, Single-Arm Trial of Poziotinib as Salvage Treatment in Patients With Metastatic Breast Cancer Who Has HER2 or EGFR Mutation or Activated AR or EGFR Pathway Poziotinib - Metastatic Breast Cancer | Phase 2 | Completed | Samsung Medical Center | 5 | 2015-09-01 | 2020-07-07 |
| Poziotinib in Patients With HER2+ Recurrent Stage IV BC Who Have Received at Least 2 Prior HER2-directed Regimens NOV120101 (Poziotinib) - Metastatic Breast Cancer | Phase 2 | Completed | Hanmi Pharmaceutical Company Limited | 106 | 2015-04-01 | 2022-01-20 |
| Phase II Trial of HM781-36B in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of or Unfit for Platinum-containing Therapy HM781-36B - HNSCC | Phase 2 | Unknown | Yonsei University | 49 | 2014-08-01 | 2019-03-18 |
| NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma NOV120101 (Poziotinib) - Adenocarcinoma of Lung Stage IIIB, Adenocarcinoma of Lung Stage IV | Phase 2 | Terminated | National OncoVenture | 22 | 2013-03-01 | 2016-03-01 |
| NOV120101 Phase 2 Study in NSCLC Patients With Aquired Resistance to 1st Generation EGFR Tyrosine Kinase Inhibitors NOV120101 (Poziotinib) - Increased Drug Resistance | Phase 2 | Completed | National OncoVenture | 40 | 2013-01-01 | 2015-08-14 |
| A Phase I-II Study of HM781-36B Combined With Paclitaxel and Trastuzumab in HER-2 Positive Advanced Gastric Cancer HM781-36B(Poziotinib), Paclitaxel, Trastuzumab - HER-2 Positive Advanced Gastric Cancer | Phase 1 / Phase 2 | Completed | Hanmi Pharmaceutical Company Limited | 44 | 2012-11-01 | 2016-03-03 |
| Clinical Trial to Determine the MTD of HM781-36B in Patients With Advanced Solid Tumors HM781-36B tablets - Advanced Solid Malignancies | Phase 1 | Completed | Hanmi Pharmaceutical Company Limited | 20 | 2011-06-01 | 2013-05-23 |
| Phase I Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of HM781-36B in Patients With Advanced Solid Tumors HM781-36B - Advanced Solid Tumor | Phase 1 | Completed | Hanmi Pharmaceutical Company Limited | 55 | 2009-11-01 | 2014-02-26 |
Breast Neoplasms (5) · Adenocarcinoma of Lung (2) · Carcinoma, Non-Small-Cell Lung (2) · Squamous Cell Carcinoma of Head and Neck (2) · Head and Neck Neoplasms (1) · Lung Neoplasms (1) · Recurrence (1)
Spectrum Pharmaceuticals, Inc (6) · Hanmi Pharmaceutical Company Limited (5) · M.D. Anderson Cancer Center (2) · National OncoVenture (2) · Yonsei University (2) · Korean Association for the Study of Targeted Therapy (1) · Samsung Medical Center (1) · Seoul National University Hospital (1)
South Korea (12) · United States (7) · Belgium (1) · Canada (1) · China (1) · France (1) · Israel (1) · Italy (1) · Netherlands (1) · Spain (1)
Shanta Chawla, MD (2) · Eunkyung Cho, MD, Ph.D (1) · Hwan Jung Yun (1) · Ji-Youn Han, MD. Ph.D (1) · Jungyong Kim, MD (1) · Ki Hyeong Lee, MD, Ph.D (1) · Sang-We Kim, MD, Ph.D (1) · Yasir Elamin, MD (1) · Yasir Y Elamin (1) · YoHan Kim, M.D. (1) · Young Joo Min, MD, Ph.D (1)
PMID 32860168, PMID 34528763, PMID 34550757, PMID 34843401, PMID 35820397, PMID 37699162, PMID 40782807, PMID 41527715