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A rollover study of avapritinib (also called BLU-285) in adults Who Participated in a Previous Avapritinib Study
EU CTIS ID: 2024-514969-18-00
What this study is testing
The primary objective of this rollover study is to evaluate the long term-safety of avapritini as assessed by incidence of SAEs, AESIs and AEs leading to discontinuation
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participated in a Blueprint Medicines sponsored avapritinib clinical study and is either receiving or on interrupted treatment with avapritinib. If the patient has been on drug hold for over 56 days, the Medical Monitor should be consulted prior to enrollment and study drug administration. The Sponsor reserves the right to not roll over patients who have been on drug hold for an extended time period. - Inclusion of pediatric patients with CNS tumors applies in Canada only.
- Completed the parent study treatment requirements and demonstrated compliance with the parent study requirements, as assessed by the Principal Investigator.
- Continue to clinically benefit from treatment with avapritinib, as determined by the Principal Investigator from the parent study.
- Able to give written informed consent. Written informed consent must be obtained prior to enrolling in the rollover study and receiving the study treatment. If consent cannot be expressed in writing, then the consent must be formally documented and witnessed, ideally via an independent trusted witness. For pediatric patients, the informed consent may be obtained from the patient’s parent or legal guardian. Parent(legal guardian consent will be determinde by local, regional and/or national guidelines.
- Agree to continue to use highly effective contraception as defined in this protocol.
- Female patients of childbearing potential must have negative highly sensitive serum pregnancy test within 20 days before the first dose of avapritinib. Pregnancy will be documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy. Women with β-hCG values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written approval of the Sponsor after pregnancy has been excluded. Women of non-childbearing potential (postmenopausal, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) do not require a serum β-hCG pregnancy test."
You likely can't join if
- Patient is participating in another interventional study.
- Patient is unwilling or unable to comply with study procedures and study restrictions.
- Patient is pregnant and/or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.