TRIAL DETAIL

Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA

Drug:
Trial Name:
Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Unknown
Phase:
Start Date 07/10/2022
Age of Trial (yrs) 2.9
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor + D842V inhibitor
Strategy:
Block KIT/PDGFRA
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
No.[2022]107
Sponsor:
Xinhua Zhang, MD The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
Patient Contact:
Xinhua Zhang, PhD +8620-87332200 zhangxinhua@mail.sysu.edu.cn
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Criteria

Inclusion Criteria:

Patients who are aged ≥ 18 years.
Gastrointestinal stromal tumors confirmed by histopathological examination, and CD- and/or DOG-1-positive by immunohistochemistry.
Presence of mRECIST v1.1-compliant lesions with at least one measurable lesion (non-lymphadenopathy ≥1.0 cm or ≥2-fold scan slice thickness).
Treatment with Avapritinib.
Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at screening.
Patient informed consent and signed written consent form.
The patient was compliant and voluntarily scheduled for follow-up, treatment, laboratory tests, and other study procedures.

Exclusion Criteria:

KIT or PDGFRA wild type.
Failure to complete continuous atorvastatin for at least 15 days due to intolerability or disease progression.
Other serious acute or chronic physical or mental problems, or laboratory abnormalities, may increase the risk associated with participation in the study or use of drugs, or interfere with the judgment of the study results and, in the judgment of the investigator, are not considered appropriate for participation in the investigator.

Trial Links

Trial Results

 

Drug Information

Blueprint programs
 
BLU-285 in GIST at AACR 2015
 
AACR 2015 Abstract #791: BLU-285, the first selective inhibitor of PDGFRα D842V and KIT Exon 17 mutants
 
LRG Story: Update on Blueprint Medicines Clinical Trial for BLU-285
 
2017 AACR BLU-285 Presentation by Blueprint
 
2017 AACR KU Leuven Abstract (
 
2016 EEORTC-NIH-AACR Munich Heinrich presentation
 
2019 ASCO - Clinical activity of avapritinib in 4L or greater GIST including PDGFRA exon 18 and D842V
 
Avapritinib prescribing information
 
AYVAKIT.com website, resources for patients, support program, etc.
 
Summary of Risk Management Plan for AYVAKYT (Avapritinib) - An EMA summary (PDF)
 

Trial Sites

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