Expanded Access Program for Avapritinib

NCT04714086 | Unknown

• 1 other identifier: BLU-285-PTA-Solid Tumors
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Solid Tumors

Keywords

Avapritinib; BLU-285; Solid tumors; Gastrointestinal stromal tumors (GIST); Gliomas

Interventions

Avapritinib DRUG

Avapritinib will be administered orally at 300 mg QD.

Also known as: BLU-285

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 β-hCG pregnancy test. Participants 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.
• Female participants of nonchildbearing potential (premenarchal, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) do not require a serum β-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.

Sponsors & Collaborators

• Blueprint Medicines Corporation: lead

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Glioma

Interventions

avapritinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Last Updated: October 24, 2024

Record last verified: 2024-10