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A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy.
EU CTIS ID: 2022-502269-13-00
What this study is testing
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy.
- Therapeutic exploratory (Phase II)
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
- Participants must:
- Have high-grade glioma
- Have had prior radiotherapy with or without temozolomide (patients less than 3 years old without prior radiotherapy may be eligible)
- Have recovered from major side effects of previous therapy and have adequate organ function and blood counts, as measured by lab tests
- Be able to swallow or have a feeding tube
- Be willing and able to follow study procedures, including frequent lab tests and tumor imaging
You likely can't join if
- Participants must not:
- Have glioma that came back or started growing again after receiving treatment
- Have received other therapy for this cancer, except surgery and radiotherapy (with or without temozolomide)
- Have certain alterations in their tumor that can be treated with a different therapy
- Have acute infections or any serious medical conditions (other than this cancer)
- Be pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- Australia
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, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States; Australia. 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.