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Adavosertib for Central Nervous System Tumor
Study Summary
This trial is studying the side effects and best dose of a combination of adavosertib and irinotecan hydrochloride in treating patients with solid tumors that have come back or have not responded to standard therapy.
- Central Nervous System Tumor
- Embryonal Tumor With Multilayered Rosettes
- Medulloblastoma
- Neuroblastoma
- Rhabdomyosarcoma
- Solid Tumors
- Rhabdoid Tumor
- Ganglioneuroblastoma
- Pinealoblastoma
- Brain Tumor
- Brain Stem Glioma
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 1 & 2 trial • 76 Patients • NCT02095132Trial Design
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Who is running the clinical trial?
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- You cannot swallow pills and feeding through a tube is not allowed.You have a solid tumor that has come back after treatment or is not responding to treatment, including tumors in the brain that started there or have spread from somewhere else.You have received an organ transplant in the past.You have rhabdomyosarcoma that has come back after treatment or is not responding to treatment.You must wait at least 42 days after completing immunotherapy like tumor vaccines.You have an infection that is not under control.You are currently taking a medication that is still being tested and not approved for public use.You are currently taking other medications to treat cancer.You have had a severe allergic reaction to irinotecan or certain types of antibiotics (cephalosporins or penicillin).If you can have children, you are not using two effective methods of birth control.You are able to swallow pills.You are pregnant or currently breastfeeding.You have neuroblastoma that has either come back after treatment or is not responding to treatment.You do not have any known treatments available that can cure or improve your condition and quality of life.You have fully recovered from any harmful effects caused by previous cancer treatment.
- Group 1: Treatment (irinotecan hydrochloride, adavosertib)
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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
Would I be able to help out with this research project?
"This rhabdomyosarcoma clinical trial has an age limit of 21 years old and is looking for around 76 participants."
Are there any other similar research projects to Adavosertib?
"As of today, there are 291 ongoing clinical trials for Adavosertib with 53 of them in Phase 3. Most of these trials take place Woolloongabba, Queensland; however, research is being conducted at 10332 different locations worldwide."
How many hospitals are a part of this clinical trial?
"There are a total of 24 hospitals that are participating in this clinical trial, which include the Children's Hospital of Wisconsin in Milwaukee, the Children's Hospital of Alabama in Birmingham, and the Children's Hospital of Philadelphia in Philadelphia."
How many patients are participating in this clinical trial?
"This study is not enrolling new patients at this moment. It was originally posted on March 27th, 2014 and was last edited on October 7th, 2022. If you are interested in other studies, there are 3679 trials for rhabdomyosarcoma and 291 for Adavosertib that are currently recruiting participants."
What are we hoping to achieve by conducting this research?
"The purpose of this study is to investigate the pharmacokinetic parameters of adavosertib in terms of systemic exposure and maximum plasma concentration. This will be done by measuring patients prior to receiving irinotecan, before and after they receive a dose of adavosertib, on day 2. Secondary outcomes include changes in gamma H2AX levels, percentage of neuroblastoma patients with MYCN amplification, and predictive biomarkers for adavosertib sensitivity."
What medical conditions does Adavosertib help to treat?
"This medication is used to target cancerous growths in the pancreas, but it can also be effective against metastatic neoplasms, stomach cancers, and rhabdomyosarcoma."
Are young adults eligible for this clinical trial?
"Based on the inclusion criteria for this study, it appears that applicants must be between 1 year old and 21 years old. Out of the 682 similar studies, this is one of 3500 trials involving people over the age of 65."
Are people currently being enrolled in this trial?
"According to the latest information available on clinicaltrials.gov, this study is not currently recruiting patients for participation. Although the trial was last updated on October 7th, 2022, it is not presently looking for candidates. There are 3,970 other trials that are actively searching for patients right now."
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