Pexidartinib
- Generic Name
- Pexidartinib
- Brand Names
- Turalio
- Drug Type
- Small Molecule
- Chemical Formula
- C20H15ClF3N5
- CAS Number
- 1029044-16-3
- Unique Ingredient Identifier
- 6783M2LV5X
- Background
Pexidartinib is a selective tyrosine kinase inhibitor that works by inhibiting the colony-stimulating factor (CSF1)/CSF1 receptor pathway. Pexidartinib was originally developed by Daiichi Sankyo, Inc. and it was approved by the FDA in August 2019 as the first systemic therapy for adult patients with symptomatic tenosynovial giant cell tumor. Tenosynovial gia...
- Indication
Pexidartinib is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
- Associated Conditions
- Symptomatic Tenosynovial Giant Cell Tumor
- Associated Therapies
- -
A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan
- First Posted Date
- 2021-01-11
- Last Posted Date
- 2023-07-12
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Target Recruit Count
- 21
- Registration Number
- NCT04703322
- Locations
- 🇯🇵
Osaka International Cancer Institute, Osaka, Japan
🇯🇵Kanazawa University Hospital, Ishikawa, Japan
🇯🇵Nagoya University Hospital, Aichi, Japan
Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
- First Posted Date
- 2020-08-26
- Last Posted Date
- 2023-08-08
- Lead Sponsor
- Daiichi Sankyo
- Target Recruit Count
- 32
- Registration Number
- NCT04526704
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇳🇱Leiden University Medical Center (LUMC), Leiden, Netherlands
🇺🇸Washington University, Saint Louis, Missouri, United States
A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT
- First Posted Date
- 2020-07-28
- Last Posted Date
- 2024-10-24
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Target Recruit Count
- 40
- Registration Number
- NCT04488822
- Locations
- 🇨🇳
Peking University Cancer Hospital, Beijing, China
🇨🇳The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
🇨🇳Beijing Ji Shui Tan Hospital, Beijing, China
Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants
- First Posted Date
- 2020-01-10
- Last Posted Date
- 2021-06-22
- Lead Sponsor
- Daiichi Sankyo
- Target Recruit Count
- 16
- Registration Number
- NCT04223635
- Locations
- 🇺🇸
Clinical Pharmacology of Miami, LLC., Miami, Florida, United States
🇺🇸Orlando Clinical Research Center, Orlando, Florida, United States
Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)
- Conditions
- Interventions
- First Posted Date
- 2017-09-25
- Last Posted Date
- 2021-05-14
- Lead Sponsor
- Daiichi Sankyo
- Target Recruit Count
- 32
- Registration Number
- NCT03291288
- Locations
- 🇺🇸
University of Kansas Cancer Center, Westwood, Kansas, United States
🇺🇸University of Arizona, Tucson, Arizona, United States
🇺🇸HonorHealth, Scottsdale, Arizona, United States
A Study of MEK162 (Binimetinib) in Combination With Pexidartinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST)
- Conditions
- Interventions
- First Posted Date
- 2017-05-17
- Last Posted Date
- 2021-04-30
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 3
- Registration Number
- NCT03158103
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Effect of Probenecid on Pexidartinib Pharmacokinetics
- Conditions
- Interventions
- First Posted Date
- 2017-05-03
- Last Posted Date
- 2017-05-03
- Lead Sponsor
- Daiichi Sankyo
- Target Recruit Count
- 16
- Registration Number
- NCT03138759
- Locations
- 🇺🇸
Worldwide Clinical Trials Early Phase Services, San Antonio, Texas, United States
Evaluation of Safety and Activity of an Anti-PDL1 Antibody (DURVALUMAB) Combined With CSF-1R TKI (PEXIDARTINIB) in Patients With Metastatic/Advanced Pancreatic or Colorectal Cancers
- Conditions
- Interventions
- First Posted Date
- 2016-05-19
- Last Posted Date
- 2021-09-05
- Lead Sponsor
- Centre Leon Berard
- Target Recruit Count
- 48
- Registration Number
- NCT02777710
- Locations
- 🇫🇷
Centre Léon Bérard, Lyon, France
🇫🇷IUCT-oncopole, Toulouse, France
Study of Pexidartinib in Asian Subjects With Advanced Solid Tumors
- First Posted Date
- 2016-04-12
- Last Posted Date
- 2022-04-25
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Target Recruit Count
- 12
- Registration Number
- NCT02734433
CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2015-03-30
- Last Posted Date
- 2021-05-04
- Lead Sponsor
- Cogent Biosciences, Inc.
- Target Recruit Count
- 51
- Registration Number
- NCT02401815
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸OSU Comprehensive Cancer Center, Columbus, Ohio, United States
Drug Development Updates
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