- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03862885
Early Access Program (EAP) for Avapritinib in Patients With Locally Advanced Unresectable or Metastatic GIST
July 23, 2020 updated by: Blueprint Medicines Corporation
Early Access Program (EAP) for Avapritinib in Patients With Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)
This is a US, multicenter, open-label expanded access program to provide access to avapritinib until such time that avapritinib becomes available through other mechanisms or the Sponsor chooses to discontinue the program.
Study Overview
Study Type
Expanded Access
Expanded Access Type
- Intermediate-size Population
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient is ≥ 16 years of age.
- Diagnosis of unresectable or metastatic GIST
- The patient is not eligible for an ongoing study of avapritinib or cannot access an ongoing study of avapritinib.
- Patient has received 3 or more TKI therapies including imatinib, or the patient has GIST that carries a mutation in exon 18 of the PDGFRA gene (such as D842V).
- The patient has adequate vital organ function, including heart, lungs, liver, kidneys, bone marrow and endocrine, and is expected to tolerate therapy with a TKI.
- Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent.
Exclusion Criteria:
Patients who have poor organ function as defined by one or more of the following laboratory parameters;
- Total bilirubin > 2 × ULN; or > 3 × ULN in the presence of Gilbert's Disease;
- Platelet count < 75 × 10^9/L.
- Patient requires therapy with a concomitant medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4
- Patient has had a major surgical procedure (minor surgical procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures) within 14 days of the first dose of avapritinib.
- Patient has a history of a cerebrovascular accident or transient ischemic attacks within 1 year prior to the first dose of program drug.
- Patient has a known risk of intracranial bleeding, such as a brain aneurysm or history of subdural or subarachnoid bleeding.
- Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of randomization and for at least 30 days after the last dose of avapritinib. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of first dose and for at least 90 days after the last dose of avapritinib.
- Women who are pregnant, as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy, obtained within 7 days before the randomization. Females with β-hCG values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written consent of the Sponsor, after pregnancy has been ruled out. Females of non- childbearing potential (postmenopausal for more than 1 year; bilateral tubal ligation; bilateral oophorectomy; hysterectomy) do not require a serum β-hCG test.
- Women who are breast feeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
March 1, 2019
First Submitted That Met QC Criteria
March 1, 2019
First Posted (Actual)
March 5, 2019
Study Record Updates
Last Update Posted (Actual)
July 27, 2020
Last Update Submitted That Met QC Criteria
July 23, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- BLU-285-EAP-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on GIST
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Indiana UniversityCompleted
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Novartis PharmaceuticalsActive, not recruitingGIST and CMLChina, Turkey, Singapore, France, Switzerland, Thailand, United States, Romania, Hong Kong, Finland, United Kingdom
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Leiden University Medical CenterUnknown
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European Organisation for Research and Treatment...Withdrawn
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Peking UniversityUnknown
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PfizerCompletedGISTUnited States, Switzerland, Belgium, Denmark, Spain, United Kingdom, Australia, India, France, Slovakia, Canada, Finland, Germany, Korea, Republic of, Netherlands, Poland
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Deciphera Pharmaceuticals LLCRecruitingGISTUnited States, Korea, Republic of, Spain, Taiwan, Australia, Canada, United Kingdom, Italy, Netherlands, Brazil, Chile, Poland
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Arog Pharmaceuticals, Inc.Centre Leon Berard; Fox Chase Cancer CenterUnknownGIST With D842V Mutated PDGFRA GeneUnited States, France, Spain, Italy, Germany, Norway, Poland
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National Taiwan University HospitalCompleted
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Chinese University of Hong KongRecruiting
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Blueprint Medicines CorporationActive, not recruitingGastrointestinal Stromal TumorsFrance
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Blueprint Medicines CorporationCompletedGastrointestinal Stromal Tumors (GIST) | Other Relapsed or Refractory Solid TumorsUnited States, United Kingdom, France, Korea, Republic of, Belgium, Germany, Italy, Netherlands, Poland, Spain
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Blueprint Medicines CorporationCompletedGISTUnited States, Korea, Republic of, Netherlands, China, France, Spain, Italy, Belgium, United Kingdom, Singapore, Australia, Canada, Germany, Sweden, Hungary, Austria, Czechia, Poland