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
- -
Fulvestrant + Neratinib In Breast Cancer
- First Posted Date
- 2021-05-25
- Last Posted Date
- 2023-08-01
- Lead Sponsor
- Massachusetts General Hospital
- Registration Number
- NCT04901299
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
- Conditions
- Interventions
- First Posted Date
- 2021-05-14
- Last Posted Date
- 2024-10-11
- Lead Sponsor
- Ruth O'Regan
- Target Recruit Count
- 48
- Registration Number
- NCT04886531
- Locations
- 🇺🇸
University of Illinois Cancer Center, Chicago, Illinois, United States
🇺🇸University of Wisconsin, Madison, Wisconsin, United States
🇺🇸University of Rochester Medical Center, Rochester, New York, United States
Evaluation of Neratinib for Treatment and Prevention of Subsequent CNS Event(s) in Patients With Brain Metastasis of Advanced HER2 Positive Breast Cancer
- First Posted Date
- 2021-04-23
- Last Posted Date
- 2022-03-02
- Lead Sponsor
- Jules Bordet Institute
- Registration Number
- NCT04856475
Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2021-03-04
- Last Posted Date
- 2023-07-11
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Registration Number
- NCT04781374
- Locations
- 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Center, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Real-life Pan-HER-blockade With Neratinib
- Conditions
- First Posted Date
- 2020-05-14
- Last Posted Date
- 2023-10-24
- Lead Sponsor
- Pierre Fabre Pharma GmbH
- Target Recruit Count
- 304
- Registration Number
- NCT04388384
- Locations
- 🇩🇪
Community Health Center, Neuss, North Rhine-Westphalia, Germany
🇩🇪Medical Praxis, Freital, Sachsen, Germany
🇨🇭Practice, Biel, Bern, Switzerland
Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)
- Conditions
- Interventions
- First Posted Date
- 2020-05-05
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- Scott R. Plotkin, MD, PhD
- Target Recruit Count
- 100
- Registration Number
- NCT04374305
- Locations
- 🇺🇸
UCLA Medical Center, Los Angeles, California, United States
🇺🇸University of Miami, Miami, Florida, United States
🇺🇸New York University Langone Medical Center, New York, New York, United States
A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib
- Conditions
- Interventions
- First Posted Date
- 2020-04-29
- Last Posted Date
- 2023-02-10
- Lead Sponsor
- Puma Biotechnology, Inc.
- Target Recruit Count
- 6
- Registration Number
- NCT04366713
- Locations
- 🇵🇹
Hospital CUF Descobertas, Lisboa, Portugal
Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca
- First Posted Date
- 2019-04-18
- Last Posted Date
- 2024-11-06
- Lead Sponsor
- Virginia Commonwealth University
- Target Recruit Count
- 83
- Registration Number
- NCT03919292
- Locations
- 🇺🇸
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
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
- Drug: AbemaciclibDrug: AbirateroneDrug: AfatinibBiological: BevacizumabDrug: BicalutamideProcedure: Biospecimen CollectionDrug: BortezomibDrug: CabazitaxelDrug: CabozantinibDrug: CapecitabineDrug: CarboplatinDrug: CelecoxibDrug: CobimetinibDrug: CopanlisibDrug: DabrafenibDrug: DacomitinibDrug: DarolutamideDrug: DasatinibDrug: DoxorubicinBiological: DurvalumabDrug: EnasidenibDrug: EntrectinibDrug: EnzalutamideDrug: ErlotinibDrug: EverolimusDrug: FluorouracilDrug: IdelalisibDrug: ImatinibBiological: IpilimumabDrug: LenvatinibDrug: LeucovorinDrug: LorlatinibDrug: LosartanDrug: Nab-paclitaxelDrug: NeratinibBiological: NivolumabDrug: OlaparibDrug: OxaliplatinDrug: PalbociclibDrug: PanobinostatBiological: PembrolizumabBiological: PertuzumabDrug: PonatinibOther: Quality-of-Life AssessmentDrug: RegorafenibDrug: RuxolitinibDrug: SirolimusDrug: SorafenibDrug: SunitinibDrug: TrametinibBiological: Trastuzumab EmtansineDrug: TretinoinDrug: VemurafenibDrug: VenetoclaxDrug: VismodegibDrug: Vorinostat
- 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
- 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
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.