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
Study Evaluating HKI-272 Administered to Healthy Subjects
- Conditions
- Healthy
- First Posted Date
- 2006-08-21
- Last Posted Date
- 2017-09-11
- Lead Sponsor
- Puma Biotechnology, Inc.
- Target Recruit Count
- 56
- Registration Number
- NCT00366600
- Locations
- 🇺🇸
Northwest Kinetics, Tacoma, Washington, United States
Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
- First Posted Date
- 2006-03-09
- Last Posted Date
- 2018-08-14
- Lead Sponsor
- Puma Biotechnology, Inc.
- Target Recruit Count
- 136
- Registration Number
- NCT00300781
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Boston University Medical Center, Boston, Massachusetts, United States
🇺🇸The Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer
- First Posted Date
- 2005-12-19
- Last Posted Date
- 2018-04-13
- Lead Sponsor
- Puma Biotechnology, Inc.
- Target Recruit Count
- 172
- Registration Number
- NCT00266877
- Locations
- 🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States
🇺🇸Case Western Reserve University, Cleveland, Ohio, United States
🇺🇸Vanderbilt University Medical Center, Nashville, Tennessee, United States
Study Evaluating HKI-272 in Tumors
- First Posted Date
- 2005-09-05
- Last Posted Date
- 2018-09-17
- Lead Sponsor
- Puma Biotechnology, Inc.
- Target Recruit Count
- 73
- Registration Number
- NCT00146172
- Locations
- 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
🇺🇸The Cleveland Clinic Foundation Taussig Cancer Center, Cleveland, Ohio, United States
Drug Development Updates
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