Poziotinib

Generic Name: Poziotinib

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₂₁Cl_₂FN_₄O_₃

CAS Number: 1092364-38-9

Unique Ingredient Identifier: OEI6OOU6IK

Background: Poziotinib has been used in trials studying the treatment of Breast Cancer, Metastatic Breast Cancer, Increased Drug Resistance, Adenocarcinoma of Lung Stage IV, and Adenocarcinoma of Lung Stage IIIB, among others.

Indication: 用于治疗非小细胞肺癌、乳腺癌和胃癌。对于吉非替尼和厄洛替尼耐药性EGFR L858R/T790M双突变细胞有很强的抑制作用。

Associated Conditions: -

Associated Therapies: -

Clinical Trials

A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations

Phase 3

Suspended

Conditions: NSCLC

Interventions: Drug: Poziotinib
Drug: Docetaxel

First Posted Date: 2022-05-18

Last Posted Date: 2024-11-13

Lead Sponsor: Spectrum Pharmaceuticals, Inc

Target Recruit Count: 268

Registration Number: NCT05378763

Locations: 🇺🇸
Bond Clinic, P.A., Winter Haven, Florida, United States

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Poziotinib
Drug: Itraconazole
Drug: Phenytoin
Drug: Paroxetine

First Posted Date: 2021-07-29

Last Posted Date: 2021-09-05

Lead Sponsor: Spectrum Pharmaceuticals, Inc

Target Recruit Count: 74

Registration Number: NCT04981704

Locations: 🇺🇸
Celerion, Phoenix clinical facility, Tempe, Arizona, United States

Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

Phase 2

Terminated

Conditions: NSCLC

Interventions: Drug: Poziotinib

First Posted Date: 2019-08-05

Last Posted Date: 2020-11-17

Lead Sponsor: Hanmi Pharmaceutical Company Limited

Target Recruit Count: 5

Registration Number: NCT04044170

Locations: 🇨🇳
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China
🇨🇳
The First Hospital of Jilin University, Changchun, China
🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

and more 23 locations

A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib

Phase 2

Terminated

Conditions: NSCLC
Breast Cancer

Interventions: Drug: Poziotinib

First Posted Date: 2018-11-16

Last Posted Date: 2024-03-05

Lead Sponsor: Spectrum Pharmaceuticals, Inc

Target Recruit Count: 7

Registration Number: NCT03744715

Locations: 🇺🇸
Pacific Shores Medical Group, Long Beach, California, United States
🇺🇸
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
🇺🇸
Hattiesburg Clinic Hematology Oncology, Hattiesburg, Mississippi, United States

and more 2 locations

A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer

Phase 1

Terminated

Conditions: Breast Cancer

Interventions: Drug: Poziotinib
Drug: T-DM1

First Posted Date: 2018-02-12

Last Posted Date: 2021-01-15

Lead Sponsor: Spectrum Pharmaceuticals, Inc

Target Recruit Count: 6

Registration Number: NCT03429101

Locations: 🇺🇸
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
🇺🇸
Los Angeles Hematology Oncology Medical Group, Glendale, California, United States

Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

Phase 2

Terminated

Conditions: NSCLC

Interventions: Drug: Poziotinib

First Posted Date: 2017-10-24

Last Posted Date: 2024-04-03

Lead Sponsor: Spectrum Pharmaceuticals, Inc

Target Recruit Count: 648

Registration Number: NCT03318939

Locations: 🇺🇸
UCLA Hematology/Oncology, Santa Monica, California, United States
🇺🇸
Kaiser Permanente Medical Center, Vallejo, California, United States
🇺🇸
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 60 locations

Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]

Phase 2

Completed

Conditions: Head and Neck Neoplasms
HNSCC

Interventions: Drug: BYL719
Drug: Durvalumab,Tremelimumab
Drug: Poziotinib
Drug: Nintedanib
Drug: Abemaciclib

First Posted Date: 2017-09-25

Last Posted Date: 2022-03-29

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 180

Registration Number: NCT03292250

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC

Phase 2

Active, not recruiting

Conditions: EGFR Exon 20 Mutation
ERBB2 Gene Mutation
Recurrent Lung Non-Small Cell Carcinoma
Stage IV Non-Small Cell Lung Cancer AJCC v7

Interventions: Drug: Poziotinib

First Posted Date: 2017-02-28

Last Posted Date: 2024-12-05

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 93

Registration Number: NCT03066206

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)

Phase 2

Completed

Conditions: Adenocarcinoma Lung Stage IV
HER2 Gene Mutation

Interventions: Drug: Poziotinib

First Posted Date: 2016-12-02

Last Posted Date: 2018-05-24

Lead Sponsor: Korean Association for the Study of Targeted Therapy

Target Recruit Count: 6

Registration Number: NCT02979821

Locations: 🇰🇷
Korean Association for the Study of Targeted Therapy, Seoul, Korea, Republic of

Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Poziotinib

First Posted Date: 2016-01-20

Last Posted Date: 2022-03-11

Lead Sponsor: Spectrum Pharmaceuticals, Inc

Target Recruit Count: 67

Registration Number: NCT02659514

Locations: 🇺🇸
Clearview Cancer Center, Huntsville, Alabama, United States
🇺🇸
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
🇺🇸
Marin Cancer Care, Inc, Greenbrae, California, United States

and more 32 locations

Drug Development Updates

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