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Abemaciclib + Temozolomide for Brain Cancer
Study Summary
This trial is testing whether abemaciclib can help treat brain tumors by measuring the drug's levels in participants' brain tumors and brain fluid.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My high-grade brain tumor was confirmed by tests during surgery.I do not have any active infections.I can swallow pills.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.I have severe nausea and vomiting that could interfere with taking medication.I will start Abemaciclib within 14 days of my diagnosis confirmed by imaging.I am willing to not consume grapefruit or its juice while taking abemaciclib.My blood, liver, kidney, and heart are all functioning well.It's been over 4 weeks since my last major surgery and I have no infections.I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.I can do most of my daily activities by myself.I agree to use effective birth control during and after the study as required.My cancer is a high grade or midline glioma that has come back.I cannot safely have a biopsy due to health risks.I am between 18 and 39 years old.I have never been treated with abemaciclib or similar medications.I have recovered from chemotherapy side effects, except for hair loss or mild nerve damage.I do not have any severe illnesses that would stop me from following the study's requirements.I need medication that affects liver enzymes.I or my legal representative can understand and are willing to sign the consent form.
- Group 1: 1/Abemaciclib and microdialysis monitoring
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are enrolled in the current research initiative?
"Affirmative. Data hosted on clinicaltrials.gov confirms that the trial, first posted on December 7th 2022, is currently seeking participants for enrollment. To achieve its stated objectives this study requires a total of seven individuals at one medical centre to take part."
How does the combination of abemaciclib and temozolomide impact patient safety?
"Due to a limited amount of evidence on the safety and efficacy of abemaciclib + temozolomide, our team at Power gave this combination therapy a score of 1."
Are individuals with ages below sixty years admissible to this trial?
"In accordance with the study's restrictions, only persons aged between 18 and 39 are allowed to enroll."
Is this research endeavor taking on new participants?
"Indeed, the information found on clinicaltrials.gov attests that this research endeavour is currently recruiting individuals. This study was first posted on December 7th 2022 and its most recent update was released on December 1st 2022; it requires seven participants to be enrolled in one medical centre."
Are there any particular individuals that are ideal for inclusion in this medical exploration?
"This clinical trial seeks 7 individuals with glioma that range between 18 to 39 years in age. Essential requirements for enrolment include: recurrent high grade glioma or midline glioma diagnosis, previous intra-operative pathology confirming disease (if cortical high grade gliomas present), ability to swallow pills/tablets, at least 4 weeks since major surgeries (with no proof of infection) and a 21 day washout period after chemotherapy before randomisation if applicable., completion and full convalescence from radiotherapy side effects following 14 days of rest post treatment , Karnofsky score must be equal to or greater than 50% within"
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