CLINICAL TRIALS PROFILE FOR POZIOTINIB

Clinical Trials for Poziotinib

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01718847 ↗	NOV120101 Phase 2 Study in NSCLC Patients With Aquired Resistance to 1st Generation EGFR Tyrosine Kinase Inhibitors	Completed	Hanmi Pharmaceutical Company Limited	Phase 2	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 monotherapy agent in lung adenocarcinoma patients with acquired resistance to prior EGFR tyrosine kinase inhibitors (TKIs).
NCT01718847 ↗	NOV120101 Phase 2 Study in NSCLC Patients With Aquired Resistance to 1st Generation EGFR Tyrosine Kinase Inhibitors	Completed	National OncoVenture	Phase 2	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 monotherapy agent in lung adenocarcinoma patients with acquired resistance to prior EGFR tyrosine kinase inhibitors (TKIs).
NCT01746771 ↗	A Phase I-II Study of HM781-36B Combined With Paclitaxel and Trastuzumab in HER-2 Positive Advanced Gastric Cancer	Completed	National OncoVenture	Phase 1/Phase 2	[Phase I] The main objective of this study is to evaluate the safety, tolerability and determine the Recommended Dose (RD) of HM781-36B(Poziotinib)combined with Paclitaxel and Trastuzumab [Phase II] The main objective of this study is to evaluate anticancer activity through determination of response rate of HM781-36B(Poziotinib)combined with Paclitaxel and Trastuzumab in patients with HER-2 positive advanced gastric cancer
NCT01746771 ↗	A Phase I-II Study of HM781-36B Combined With Paclitaxel and Trastuzumab in HER-2 Positive Advanced Gastric Cancer	Completed	Hanmi Pharmaceutical Company Limited	Phase 1/Phase 2	[Phase I] The main objective of this study is to evaluate the safety, tolerability and determine the Recommended Dose (RD) of HM781-36B(Poziotinib)combined with Paclitaxel and Trastuzumab [Phase II] The main objective of this study is to evaluate anticancer activity through determination of response rate of HM781-36B(Poziotinib)combined with Paclitaxel and Trastuzumab in patients with HER-2 positive advanced gastric cancer
NCT01819428 ↗	NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma	Terminated	Hanmi Pharmaceutical Company Limited	Phase 2	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 first-line monotherapeutic agent in patients with lung adenocarcinoma harboring EGFR mutation.

Clinical Trial Conditions for Poziotinib

Condition Name

Condition Name for
Intervention	Trials
NSCLC	5
Breast Cancer	4
Metastatic Breast Cancer	2
Healthy	2

Condition MeSH

Condition MeSH for
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	6
Breast Neoplasms	5
Lung Neoplasms	3
Adenocarcinoma of Lung	2

Clinical Trial Locations for Poziotinib

Trials by Country

Trials by Country for
Location	Trials
United States	52
Korea, Republic of	18
Japan	4
Canada	3
China	1

Trials by US State

Trials by US State for
Location	Trials
California	5
Pennsylvania	4
Texas	4
Mississippi	3
Florida	3

Clinical Trial Progress for Poziotinib

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	14
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	7
Recruiting	6
Terminated	4

Clinical Trial Sponsors for Poziotinib

Sponsor Name

Sponsor Name for
Sponsor	Trials
Spectrum Pharmaceuticals, Inc	11
Hanmi Pharmaceutical Company Limited	6
National OncoVenture	4

Sponsor Type

Sponsor Type for
Sponsor	Trials
Other	19
Industry	17
NIH	1