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NCT04714086 Clinical Trial

Expanded Access Program for Avapritinib

Solid Tumors Clinical Trial

Official title:
Expanded Access Program (EAP) for Avapritinib

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT04714086
Other study ID # BLU-285-PTA-Solid Tumors
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date September 2023
Source Blueprint Medicines Corporation
Contact Blueprint Medicines
Phone 617-714-6707
Email medinfo@blueprintmedicines.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

This record comprises the currently available Expanded Access Programs (EAP) for avapritinib (BLU-285): 1) A Post Trial Access (PTA) program to provide continued access to treatment with avapritinib to BLU-285-1107 participants with solid tumors who are unable to access commercially available avapritinib after trial BLU-285-1107 (NCT04908176) has ended.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: -Participant has received treatment with avapritinib in BLU-285-1107 clinical trial and continues to receive clinical benefit from avapritinib treatment, as assessed by the Investigator. Exclusion Criteria: - Participant requires ongoing treatment or has received treatment within 28 days before the start of avapritinib administration with drugs or foods that are strong CYP3A inhibitors or inducers. - Female participants of childbearing potential who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of informed consent and for at least 6 weeks after the last dose of study treatment. - Male participants who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of informed consent and for at least 6 weeks after the last dose of study treatment. - Participant is pregnant, as documented by a serum ß-hCG pregnancy test. Participants with ß- 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. - Female participants of nonchildbearing potential (premenarchal, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) do not require a serum ß-hCG test. - Participant is breastfeeding. - Participants who require anticoagulants, with the exception of stable doses of prophylactic reversible anticoagulants. - Participants who are unable to swallow tablets.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Avapritinib
Avapritinib will be administered orally at 300 mg QD.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Blueprint Medicines Corporation
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