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
Safety and Dose Finding Study of Neratinib in Children and Young Adults With Cancer That Has Returned or Not Responded to Treatment
- Conditions
- Central Nervous System TumorSolid TumorLeukemiaLymphoma
- 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
- Conditions
- HER2 Positive Breast CarcinomaStage IV Breast Cancer AJCC v6 and v7
- Interventions
- Other: Comprehensive Geriatric AssessmentOther: Laboratory Biomarker AnalysisOther: Pharmacological Study
- 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
Phase1 of Neratinib+Trastuzumab, Pertuzumab, Paclitaxel in Patients With Advanced Solid Tumors/HER2+
- Conditions
- Solid Tumor
- Interventions
- First Posted Date
- 2015-11-01
- Last Posted Date
- 2017-11-17
- Lead Sponsor
- Michelle Melisko
- Target Recruit Count
- 6
- Registration Number
- NCT02593708
- Locations
- 🇺🇸
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide
- Conditions
- Early Stage HER2+ Breast Cancer
- Interventions
- First Posted Date
- 2015-03-27
- Last Posted Date
- 2022-05-06
- Lead Sponsor
- Puma Biotechnology, Inc.
- Target Recruit Count
- 563
- Registration Number
- NCT02400476
- Locations
- 🇺🇸
Compassionate Care Research Group Inc., Riverside, California, United States
🇺🇸Emad Ibrahim, M.D., Inc., Redlands, California, United States
🇺🇸The Oncology Institute of Hope and Innovation, Santa Ana, California, United States
Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects
- First Posted Date
- 2015-01-08
- Last Posted Date
- 2016-05-11
- Lead Sponsor
- Puma Biotechnology, Inc.
- Target Recruit Count
- 15
- Registration Number
- NCT02334501
- Locations
- 🇺🇸
Celerion, Tempe, Arizona, United States
A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer
- First Posted Date
- 2014-09-10
- Last Posted Date
- 2023-01-26
- Lead Sponsor
- NSABP Foundation Inc
- Target Recruit Count
- 49
- Registration Number
- NCT02236000
- Locations
- 🇺🇸
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
🇺🇸Cancer Care Specialists of Central Illinois, Decatur, Illinois, United States
🇺🇸UPMC- St. Margaret, Pittsburgh, Pennsylvania, United States
Safety and Efficacy Study of Neratinib and Cetuximab to Treat Patients With Quadruple Wild-Type Metastatic Colorectal Cancer
- First Posted Date
- 2013-10-10
- Last Posted Date
- 2021-10-27
- Lead Sponsor
- NSABP Foundation Inc
- Registration Number
- NCT01960023
- Locations
- 🇺🇸
Saint Luke's Mountain States Tumor Institute, Boise, Idaho, United States
🇺🇸Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
🇺🇸MD Anderson Cancer Center Orlando, Orlando, Florida, United States
Single Subject Neratinib in Bladder Cancer (NRR)
- Conditions
- Bladder Cancer
- First Posted Date
- 2013-10-08
- Last Posted Date
- 2017-03-14
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Registration Number
- NCT01956253
- Locations
- 🇺🇸
North Carolina Cancer Hospital (UNC), Chapel Hill, North Carolina, United States
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
- Conditions
- Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
- Interventions
- First Posted Date
- 2013-10-01
- Last Posted Date
- 2024-03-12
- Lead Sponsor
- Puma Biotechnology, Inc.
- Target Recruit Count
- 582
- Registration Number
- NCT01953926
- Locations
- 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇮🇹Istituto Europeo di Oncologia (IEO) I.R.C.C.S., Milano, Italy
🇺🇸Gundersen Center for Cancer and Blood Disorders, La Crosse, Wisconsin, United States
Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer
- Conditions
- HER2-mutant Non-Small Cell Lung Cancer
- Interventions
- First Posted Date
- 2013-04-09
- Last Posted Date
- 2018-07-03
- Lead Sponsor
- Puma Biotechnology, Inc.
- Target Recruit Count
- 62
- Registration Number
- NCT01827267
- Locations
- 🇺🇸
Johns Hopkins, Baltimore, Maryland, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Drug Development Updates
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