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
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveAnatomic Stage IV Breast Cancer AJCC v8AnemiaAnn Arbor Stage III Hodgkin LymphomaAnn Arbor Stage III Non-Hodgkin LymphomaAnn Arbor Stage IV Hodgkin LymphomaAnn Arbor Stage IV Non-Hodgkin LymphomaAtypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveCastration-Resistant Prostate Carcinoma
- Interventions
- Biological: BevacizumabProcedure: Biospecimen CollectionBiological: DurvalumabBiological: IpilimumabBiological: NivolumabBiological: PembrolizumabBiological: PertuzumabOther: Quality-of-Life AssessmentBiological: Trastuzumab Emtansine
- First Posted Date
- 2019-03-18
- Last Posted Date
- 2024-03-04
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 2
- Registration Number
- NCT03878524
- Locations
- 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast
- Conditions
- Early-stage Breast CancerTriple Negative Breast CancerHER2-positive Breast Cancer
- Interventions
- First Posted Date
- 2019-01-23
- Last Posted Date
- 2023-12-18
- Lead Sponsor
- West Cancer Center
- Target Recruit Count
- 27
- Registration Number
- NCT03812393
- Locations
- 🇺🇸
West Cancer Center, Germantown, Tennessee, United States
Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status
- Conditions
- Metastatic Colorectal Cancer
- 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
- Breast Cancer
- Interventions
- First Posted Date
- 2017-12-19
- Last Posted Date
- 2025-04-15
- 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
- 2025-01-29
- 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
- Advanced Breast Cancer
- 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
- Stage III Breast Cancer AJCC v7Stage IIIB Breast Cancer AJCC v7Breast Inflammatory CarcinomaStage IIIA Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7Metastatic Breast CarcinomaLocally Advanced Breast CarcinomaStage IV Breast Cancer AJCC v6 and v7
- Interventions
- Other: Laboratory Biomarker Analysis
- First Posted Date
- 2017-04-05
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 34
- 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
- HER2-positive Breast CancerStage II Breast Cancer AJCC v6 and v7Breast AdenocarcinomaStage IIA Breast Cancer AJCC v6 and v7Stage IIIC Breast Cancer AJCC v7Stage IIIB Breast Cancer AJCC v7Stage IIB Breast Cancer AJCC v6 and v7Stage III Breast Cancer AJCC v7Stage IIIA Breast Cancer AJCC v7
- Interventions
- Biological: Trastuzumab
- 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
- Advanced Malignant Solid NeoplasmERBB4 Gene MutationRefractory Malignant Solid NeoplasmERBB3 Gene MutationKRAS Gene MutationERBB2 Gene MutationEGFR Gene MutationERBB2 Gene AmplificationMetastatic Malignant Solid NeoplasmEGFR Gene Amplification
- Interventions
- First Posted Date
- 2017-02-27
- Last Posted Date
- 2025-02-10
- 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
- Glioblastoma
- 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
Drug Development Updates
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