Neratinib

Generic Name
Neratinib
Brand Names
Nerlynx
Drug Type
Small Molecule
Chemical Formula
C30H29ClN6O3
CAS Number
698387-09-6
Unique Ingredient Identifier
JJH94R3PWB
Background

Neratinib was approved in July 2017 for use as an extended adjuvant therapy in Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer. Approval was granted to Puma Biotechnology Inc. for the tradename Nerlynx. Neratinib is currently under investigation for use in many other forms of cancer.

Indication

For use as an extended adjuvant treatment in adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy [FDA Label].

Associated Conditions
Breast Cancer
Associated Therapies
-
Clinical Trials
Related News

Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: neratinib
First Posted Date
2007-10-29
Last Posted Date
2012-05-14
Lead Sponsor
Puma Biotechnology, Inc.
Target Recruit Count
6
Registration Number
NCT00550212

Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects

Phase 1
Completed
Conditions
Healthy
First Posted Date
2007-07-10
Last Posted Date
2012-05-14
Lead Sponsor
Puma Biotechnology, Inc.
Target Recruit Count
36
Registration Number
NCT00498745

A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors

Phase 1
Completed
Conditions
Tumors
Interventions
Drug: neratinib
First Posted Date
2006-11-08
Last Posted Date
2018-09-14
Lead Sponsor
Puma Biotechnology, Inc.
Target Recruit Count
21
Registration Number
NCT00397046
Locations
🇯🇵

Shizuoka Cancer Center, Shizuoka, Japan

🇯🇵

The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto, Tokyo, Japan

HKI-272 Ketoconazole Drug Interaction Study

Phase 1
Completed
Conditions
Healthy
First Posted Date
2006-09-25
Last Posted Date
2012-05-14
Lead Sponsor
Puma Biotechnology, Inc.
Target Recruit Count
24
Registration Number
NCT00380328

Study Evaluating HKI-272 Administered to Healthy Subjects

Phase 1
Completed
Conditions
Healthy
First Posted Date
2006-08-21
Last Posted Date
2017-09-11
Lead Sponsor
Puma Biotechnology, Inc.
Target Recruit Count
56
Registration Number
NCT00366600
Locations
🇺🇸

Northwest Kinetics, Tacoma, Washington, United States

Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

Phase 2
Completed
Conditions
Neoplasms
Breast Neoplasms
Interventions
Drug: neratinib
First Posted Date
2006-03-09
Last Posted Date
2018-08-14
Lead Sponsor
Puma Biotechnology, Inc.
Target Recruit Count
136
Registration Number
NCT00300781
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Boston University Medical Center, Boston, Massachusetts, United States

🇺🇸

The Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

and more 30 locations

Study Evaluating HKI-272 in Tumors

Phase 1
Completed
Conditions
Breast Neoplasms
Interventions
Drug: neratinib
First Posted Date
2005-09-05
Last Posted Date
2018-09-17
Lead Sponsor
Puma Biotechnology, Inc.
Target Recruit Count
73
Registration Number
NCT00146172
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

🇺🇸

The Cleveland Clinic Foundation Taussig Cancer Center, Cleveland, Ohio, United States

and more 2 locations
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