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Abemaciclib Combination Therapy for Neuroblastoma
Study Summary
This trial is testing the safety and effectiveness of two different combinations of drugs for treating pediatric and young adult cancer patients who have not responded to other treatments.
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.Side effects data
From 2018 Phase 2 trial • 132 Patients • NCT02102490Trial Design
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Who is running the clinical trial?
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- I have received a bone marrow or organ transplant from another person.I and my caregiver can commit to the full duration of the trial.I can swallow.I weigh at least 10 kg and my body surface area is at least 0.5. My cancer has worsened despite treatment.I have a blockage in my intestines.I have stopped all cancer treatments and recovered from major side effects.I haven't taken strong drugs affecting liver enzymes recently.My blood and organs were functioning well within 2 weeks before starting the study drug.I will use effective birth control during and after the trial as required.My body surface area is at least 0.3 square meters.I have had treatment before for my returning or resistant neuroblastoma.My doctor expects me to live at least 8 weeks and I can complete a treatment cycle.My neuroblastoma has come back or did not respond to treatment.I'm sorry, but I need more information about the specific criteria in order to provide a summary. Could you please provide more details about the criteria you would like me to summarize?I do not have any ongoing infections or high viral levels.I am younger than 21 years old.I haven't had cancer that could interfere with this study's results in the last 3 years, except for certain skin cancers or treated cervical/breast cancers.I can do most activities but may need help, regardless of my age.I am eligible for parts A and B of the study.I have received a live vaccine recently.You have experienced severe side effects or allergic reactions to the study treatment or its ingredients.I am 18 years old or younger.I have been treated with CDK 4 & 6 inhibitors before.I am a woman who can have children and have a negative pregnancy test.
- Group 1: Dose Escalation: Abemaciclib + Irinotecan + Temozolomide
- Group 2: Dose Expansion: Abemaciclib + Irinotecan + Temozolomide
- Group 3: Dose Escalation: Abemaciclib + Temozolomide
- Group 4: Dose Expansion: Abemaciclib + Temozolomide
- Group 5: Part C Stage 1: Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide
- Group 6: Part C Stage 2: Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide
- 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
For what purpose is Abemaciclib most commonly prescribed?
"Abemaciclib is often used as a treatment for progression, disease. Additionally, this medication can be helpful for patients struggling with advance directives, colorectal carcinoma, and ovarian cancer."
In how many different hospitals is this medical study being run today?
"In addition to Cook Children's Hospital in Fort Worth, Texas and CHU Sainte-Justine in Montreal, Quebec; this clinical trial is also enrolling patients at Phoenix Children's Hospital. There are a total of 15 enrolment locations."
To the best of your knowledge, is Abemaciclib a common drug in research?
"558 medical studies are currently looking into the efficacy of Abemaciclib. Of these, 93 have reached Phase 3 testing. Most trials for Abemaciclib are being conducted in Woolloongabba, Queensland; however, there are 17874 total locations running clinical trials for this medication."
Is this research still enrolling individuals?
"That is correct. The listing on clinicaltrials.gov currently says that the trial is recruiting participants. It was first posted on November 9th, 2020 and was last edited on the same date in 2022. There are 117 spots open at 13 different sites."
How many research participants are being sought for this project?
"Yes, the trial is currently ongoing and actively recruiting patients. According to the information available on clinicaltrials.gov, the trial was originally posted on 11/9/2020 and was most recently edited on 11/9/2022. The study is looking for 117 participants across 13 locations."
What is the primary purpose of this clinical trial?
"The objective of this trial is to monitor the pharmacokinetics of abemaciclib over a period of up to 24 months. Secondary objectives include clinical benefit rate, overall response rate, and progression-free survival."
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