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
- -
Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status
- Conditions
- Interventions
- First Posted Date
- 2018-03-08
- Last Posted Date
- 2022-03-31
- Lead Sponsor
- NSABP Foundation Inc
- Target Recruit Count
- 35
- Registration Number
- NCT03457896
- Locations
- 🇺🇸
Kaiser Permanente-Anaheim, Anaheim, California, United States
🇺🇸Kaiser Permanente-Zion, San Diego, California, United States
🇺🇸Kaiser Permanente-San Francisco, San Francisco, California, United States
Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2017-12-19
- Last Posted Date
- 2024-04-18
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 34
- Registration Number
- NCT03377387
- Locations
- 🇺🇸
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
🇺🇸Hartford Healthcare Cancer Institute @ Hartford Hospital, Hartford, Connecticut, United States
🇺🇸Baptist Alliance - McI, Miami, Florida, United States
Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer
- First Posted Date
- 2017-09-20
- Last Posted Date
- 2024-02-13
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 21
- Registration Number
- NCT03289039
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸UT Southwestern, Dallas, Texas, United States
🇺🇸The Ohio State University, Columbus, Ohio, United States
The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial
- Conditions
- Interventions
- First Posted Date
- 2017-06-09
- Last Posted Date
- 2019-01-22
- Lead Sponsor
- Institute of Cancer Research, United Kingdom
- Target Recruit Count
- 1150
- Registration Number
- NCT03182634
- Locations
- 🇬🇧
Western General Hospital, Edinburgh, United Kingdom
🇬🇧Royal Marsden Hosital, Sutton, England, United Kingdom
🇬🇧Clatterbridge Cancer Centre, Liverpool, United Kingdom
Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2017-04-05
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 43
- Registration Number
- NCT03101748
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib
- Conditions
- Interventions
- First Posted Date
- 2017-03-29
- Last Posted Date
- 2023-11-18
- Lead Sponsor
- University of California, San Francisco
- Target Recruit Count
- 11
- Registration Number
- NCT03094052
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation
- Conditions
- Interventions
- First Posted Date
- 2017-02-27
- Last Posted Date
- 2024-06-26
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 93
- Registration Number
- NCT03065387
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
- Conditions
- Interventions
- First Posted Date
- 2016-11-30
- Last Posted Date
- 2024-10-17
- Lead Sponsor
- Patrick Wen, MD
- Target Recruit Count
- 460
- Registration Number
- NCT02977780
- Locations
- 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Safety and Dose Finding Study of Neratinib in Children and Young Adults With Cancer That Has Returned or Not Responded to Treatment
- Conditions
- Interventions
- First Posted Date
- 2016-10-13
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 14
- Registration Number
- NCT02932280
- Locations
- 🇺🇸
University of Texas, San Antonio, Texas, United States
🇺🇸Huntsman Cancer Institue, Salt Lake City, Utah, United States
🇺🇸Arkansas Children's Hospital, Little Rock, Arkansas, United States
Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer
- First Posted Date
- 2016-02-03
- Last Posted Date
- 2023-06-18
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 25
- Registration Number
- NCT02673398
- Locations
- 🇺🇸
City of Hope Mission Hills, Mission Hills, California, United States
🇺🇸City of Hope Rancho Cucamonga, Rancho Cucamonga, California, United States
🇺🇸City of Hope Antelope Valley, Lancaster, California, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.