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

Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Paclitaxel
Biological: trastuzumab
Drug: Neratinib

First Posted Date: 2011-08-25

Last Posted Date: 2014-07-08

Lead Sponsor: NSABP Foundation Inc

Target Recruit Count: 21

Registration Number: NCT01423123

Locations: 🇺🇸
West Virginia University Hospitals, Morgantown, West Virginia, United States
🇺🇸
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
NSABP Foundation, Inc., Pittsburgh, Pennsylvania, United States

and more 1 locations

A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

Completed

Conditions: Healthy

Interventions: Drug: Neratinib

First Posted Date: 2010-06-11

Last Posted Date: 2012-05-14

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 28

Registration Number: NCT01142063

Locations: 🇺🇸
Investigational Site, New Haven, Connecticut, United States

A Study Of Neratinib (HKI-272) And Capecitabine In Japanese With Solid Tumor

Phase 1

Completed

Conditions: Advanced Malignant Solid Tumors

Interventions: Drug: Neratinib
Drug: Capecitabine

First Posted Date: 2010-05-24

Last Posted Date: 2018-12-19

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 7

Registration Number: NCT01128842

Locations: 🇯🇵
Investigational Site, Tokyo, Japan

Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Temsirolimus
Drug: Neratinib

First Posted Date: 2010-04-28

Last Posted Date: 2018-09-26

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 99

Registration Number: NCT01111825

Locations: 🇺🇸
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇪🇸
Hospital Universitario Vall d'Hebron, Barcelona, Spain
🇺🇸
Western Regional Medical Center, Inc., Goodyear, Arizona, United States

and more 9 locations

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Phase 2

Recruiting

Conditions: HER2-negative Breast Cancer
Hormone Receptor Positive Tumor
Angiosarcoma
TNBC - Triple-Negative Breast Cancer
Breast Neoplasms
Breast Tumors
HER2-positive Breast Cancer
Hormone Receptor Negative Tumor
Breast Cancer
Early-stage Breast Cancer

Interventions: Drug: Standard Therapy
Drug: AMG 386 with or without Trastuzumab
Drug: AMG 479 (Ganitumab) plus Metformin
Drug: MK-2206 with or without Trastuzumab
Drug: T-DM1 and Pertuzumab
Drug: Pertuzumab and Trastuzumab
Drug: Ganetespib
Drug: ABT-888
Drug: Neratinib
Drug: PLX3397
Drug: Pembrolizumab - 4 cycle
Drug: Talazoparib plus Irinotecan
Drug: Patritumab and Trastuzumab
Drug: Pembrolizumab - 8 cycle
Drug: SGN-LIV1A
Drug: Durvalumab plus Olaparib
Drug: SD-101 + Pembrolizumab
Drug: Tucatinib plus trastuzumab and pertuzumab
Drug: Cemiplimab
Drug: Cemiplimab plus REGN3767
Drug: Trilaciclib with or without trastuzumab + pertuzumab
Drug: SYD985 ([vic-]trastuzumab duocarmazine)
Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab
Drug: Dan222 + Niraparib
Drug: Sarilumab + Cemiplimab + Paclitaxel
Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab
Drug: Amcenestrant
Drug: Amcenestrant + Abemaciclib
Drug: Amcenestrant + Letrozole
Drug: ARX788
Drug: ARX788 + Cemiplimab
Drug: VV1 + Cemiplimab
Drug: Datopotamab deruxtecan
Drug: Datopotamab deruxtecan + Durvalumab
Drug: Zanidatamab
Drug: Lasofoxifene
Drug: Z-endoxifen
Drug: ARV-471
Drug: ARV-471 + Letrozole
Drug: ARV-471 + Abemaciclib
Drug: Endoxifen + Abemaciclib
Drug: Rilvegostomig + TDXd
Drug: AMG 386 and Trastuzumab

First Posted Date: 2010-01-05

Last Posted Date: 2024-10-22

Lead Sponsor: QuantumLeap Healthcare Collaborative

Target Recruit Count: 5000

Registration Number: NCT01042379

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
University of Texas, Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
University of Kansas, Westwood, Kansas, United States

and more 33 locations

Phase II Randomized Trial Evaluating Neoadjuvant Therapy With Neratinib and/or Trastuzumab Followed by Postoperative Trastuzumab in Women With Locally Advanced HER2-positive Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Paclitaxel
Drug: Trastuzumab
Drug: Neratinib
Drug: Doxorubicin
Drug: Cyclophosphamide

First Posted Date: 2009-11-05

Last Posted Date: 2021-10-25

Lead Sponsor: NSABP Foundation Inc

Target Recruit Count: 141

Registration Number: NCT01008150

Locations: 🇺🇸
Edward Cancer Center Plainfield, Plainfield, Illinois, United States
🇺🇸
University Hospital and Medical Center - SUNY Stony Brook, Stony Brook, New York, United States
🇺🇸
West Virginia University Hospitals Inc., Morgantown, West Virginia, United States

and more 38 locations

Study Evaluating Neratinib In Combination With Vinorelbine In Subjects With Advanced Or Metastatic Solid Tumors

Phase 1

Completed

Conditions: Advanced Malignant Solid Tumors

Interventions: Drug: Neratinib
Drug: Vinorelbine

First Posted Date: 2009-08-13

Last Posted Date: 2018-06-28

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 6

Registration Number: NCT00958724

Locations: 🇯🇵
Shizuoka Cancer Center, Shizuoka, Japan
🇯🇵
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan

Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib

Phase 1

Withdrawn

Conditions: Healthy

Interventions: Drug: Neratinib

First Posted Date: 2009-07-03

Last Posted Date: 2012-05-14

Lead Sponsor: Puma Biotechnology, Inc.

Registration Number: NCT00932464

Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Neratinib
Drug: Trastuzumab
Drug: Paclitaxel

First Posted Date: 2009-06-05

Last Posted Date: 2018-08-22

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 479

Registration Number: NCT00915018

Locations: 🇫🇷
Service d'Oncologie et de Radiotherapie, Polyclinique Francheville, Perigueux, France
🇷🇴
Institutul Oncologic Prof. Dr. Ion Chiricuţă, Cluj-Napoca, Cluj, Romania
🇪🇸
Hospital Universitario Fundación Alcorcón, Alcorcon, Madrid, Spain

and more 191 locations

Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: neratinib
Other: placebo

First Posted Date: 2009-04-09

Last Posted Date: 2021-06-11

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 2840

Registration Number: NCT00878709

Locations: 🇺🇸
Mercy Hospital Oncology/Hematology Center, Portland, Maine, United States
🇺🇸
Cancer Specialists of South Texas, P.A., Corpus Christi, Texas, United States
🇺🇸
University Hospitals, Cleveland Medical Center, Cleveland, Ohio, United States

and more 482 locations

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