Neratinib

Generic Name: Neratinib

Brand Names: Nerlynx

Drug Type: Small Molecule

Chemical Formula: C_₃₀H_₂₉ClN_₆O_₃

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

Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of Neratinib

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: Neratinib

First Posted Date: 2009-03-18

Last Posted Date: 2012-05-14

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 24

Registration Number: NCT00864487

Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Digoxin
Drug: Neratinib

First Posted Date: 2009-03-12

Last Posted Date: 2012-05-14

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 27

Registration Number: NCT00860223

Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

Phase 1

Completed

Conditions: Neoplasms
Malignant Carcinoma

Interventions: Drug: Neratinib
Drug: Temsirolimus

First Posted Date: 2009-02-06

Last Posted Date: 2018-09-18

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 63

Registration Number: NCT00838539

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇫🇷
Institut Gustave Roussy, Villejuif, France

and more 1 locations

Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: neratinib

First Posted Date: 2008-12-23

Last Posted Date: 2012-05-14

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 24

Registration Number: NCT00814060

Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

Phase 2

Completed

Conditions: Advanced Breast Cancer
Breast Cancer

Interventions: Drug: Neratinib
Drug: Lapatinib
Drug: Capecitabine

First Posted Date: 2008-10-22

Last Posted Date: 2018-08-09

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 233

Registration Number: NCT00777101

Locations: 🇿🇦
The Medical Oncology Centre of Rosebank, Johannesburg, Gauteng, South Africa
🇹🇭
Division of Medical Oncology, Department of Medicine, Bangkok-noi, Bangkok, Thailand
🇬🇧
Broomfield Hospital, Chelmsford, Essex, United Kingdom

and more 149 locations

Study Evaluating Safety And Tolerability, Solid Tumor

Phase 1

Completed

Conditions: Advanced Malignant Solid Tumors

Interventions: Drug: Neratinib
Drug: Paclitaxel

First Posted Date: 2008-10-08

Last Posted Date: 2018-11-19

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 10

Registration Number: NCT00768469

Locations: 🇯🇵
Investigational Site, Tokyo, Japan

Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: neratinib

First Posted Date: 2008-09-23

Last Posted Date: 2012-05-14

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 50

Registration Number: NCT00757809

Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Neratinib
Drug: Capecitabine

First Posted Date: 2008-08-26

Last Posted Date: 2018-09-05

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 105

Registration Number: NCT00741260

Locations: 🇦🇺
Border Medical Oncology, Wodonga, Victoria, Australia
🇭🇷
University Hospital Center Zagreb Department of Oncology, Zagreb, Croatia
🇷🇺
Saint-Petersburg State Medical University n.a. acad. I.P. Pavlov, Laboratory of Thoracic Oncology of Pulmonology Research Institute, Saint Petersburg, Russian Federation

and more 34 locations

Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: neratinib
Other: Placebo
Drug: Moxifloxacin

First Posted Date: 2008-07-02

Last Posted Date: 2012-05-14

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 60

Registration Number: NCT00708903

Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer
Advanced Malignant Solid Tumors

Interventions: Drug: neratinib
Drug: vinorelbine

First Posted Date: 2008-06-27

Last Posted Date: 2018-08-09

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 92

Registration Number: NCT00706030

Locations: 🇺🇸
Albert Einstein Cancer Center, Bronx, New York, United States
🇫🇷
Centre Paul Papin, Angers, France
🇪🇸
Centro Oncologico de Galicia, A Coruña, Spain

and more 32 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy