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Abemaciclib for Bladder Cancer (CLONEVO Trial)
CLONEVO Trial Summary
This trial looks at whether the drug Abemaciclib can shrink tumors before surgery. Tissue from the tumors will be collected before and after patients take the drug to see if there is a difference.
CLONEVO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCLONEVO Trial Timeline
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 • NCT02102490CLONEVO Trial Design
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Who is running the clinical trial?
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- I agree to use birth control as advised by my doctor.I am 18 years old or older.I do not have serious or uncontrolled health conditions.My blood tests, liver function, and ability to take pills are all within normal ranges.I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.I am taking medication that strongly affects liver enzyme activity.I have not had major surgery in the last 14 days.My bladder cancer is mostly urothelial and confirmed by tissue analysis.I cannot or choose not to undergo chemotherapy with cisplatin.I do not have any ongoing infections.My cancer is advanced and cannot be removed by surgery.You have had certain heart problems in the past.I do not have an active cancer other than non-dangerous skin or localized prostate cancer.I am medically cleared for bladder tumor surgery and bladder removal.I have received cancer treatment recently.
- Group 1: All Subjects
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
In what medical conditions is Abemaciclib most frequently prescribed?
"Abemaciclib is a commonly prescribed treatment for high risk of recurrence, but has also been used to treat advanced HR+Her2- breast cancer and other endocrine therapies."
Are there any locations in North America that are offering this experiment?
"This study is actively seeking participants from several medical centres, including NewYork-Presbyterian Brooklyn Methodist Hospital in Brooklyn, Weill Cornell Medicine in Manhattan, UT Southwestern Medical Center - Simmons Comprehensive Cancer Center in Dallas and 4 other locations."
Could you please provide an overview of past research conducted on Abemaciclib?
"Abemaciclib has been studied in the scientific community since 2010, when it was first researched at City of Hope. Since then, 31 clinical trials have concluded and 91 are still ongoing; many of these active studies take place in Brooklyn, New york."
Is recruitment for this experiment still occurring?
"Clinicaltrials.gov attests that this medical study is actively searching for enrollees; the trial was first posted on February 5th 2019 and has been adjusted most recently as of July 27th 2022."
What is the enrollment capacity for this trial?
"Eli Lilly and Company is responsible for the coordination of this medical trial, which necessitates 20 participants that fit the eligibility criteria. The study will be conducted from multiple clinical sites including NewYork-Presbyterian Brooklyn Methodist Hospital in Brooklyn, NY and Weill Cornell Medicine located in Texas."
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