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Abemaciclib for Kaposi Sarcoma
Study Summary
This trial is studying a drug called abemaciclib to see if it can help treat people with Kaposi sarcoma.
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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- Your blood counts, liver function, and kidney function need to be within certain ranges. Your heart's pumping function also needs to be above a certain level.I've been on ART for 8 weeks without KS improvement in the last 4 weeks.You have had serious allergic reactions to drugs similar to the CDK inhibitor.My heart is healthy enough for this trial, according to NYHA class 2B or better.I have recovered from side effects of previous cancer treatments, except for hair loss or nerve issues.I have Kaposi's sarcoma and my previous treatment didn’t work well.My hepatitis B virus load is undetectable with treatment.I have at least 5 skin lesions from Kaposi's sarcoma that haven't been treated with radiation or surgery.I can swallow pills.My Kaposi sarcoma diagnosis is confirmed by NCI's Pathology Lab.Your disease can be measured by specific criteria from the AIDS Clinical Trials Group Oncology Committee.My HIV status can be either positive or negative.I am not pregnant.I do not have active KSHV-related diseases.I have another cancer, but it won't affect this treatment's safety or results.I have interstitial lung disease.I can care for myself but may not be able to do active work.I am older than 18 years.I finished my radiotherapy at least 14 days ago and have recovered from its immediate effects.I haven't had chemotherapy or immunotherapy in the last 3 weeks.I am not taking any strong or moderate CYP3A4 inhibitors.I have Kaposi's sarcoma and haven't had systemic therapy for it.I have Kaposi's sarcoma and my previous treatment didn’t work well.I am HIV positive and on effective treatment.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I do not have any severe infections that are not under control.
- 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.
- Group 1: 1/Dose Determination/De-Escalation
- Group 2: 2/Dose Expansion: Group 2a
- Group 3: 2/Dose Expansion: Group 2b
Frequently Asked Questions
What medical ailments has Abemaciclib shown to be effective in treating?
"Abemaciclib is indicated for the treatment of high-risk breast cancer patients with a history of recurrence, those who are advanced hr+ her2-, and those undergoing endocrine therapy."
To the best of your knowledge, does this research project have any historical precedent?
"Abemaciclib has undergone 97 clinical trials since 2009, with the most recent one completed in 2020. These trials have taken place across 41 countries and 1276 cities. The first trial was sponsored by Eli Lilly and Company and involved 220 patients. It reached Phase 1 drug approval in 2009."
How many subjects are enrolling in this clinical trial?
"Yes, this study is still enrolling patients according to the information on clinicaltrials.gov. The listing was first posted on September 29th, 2021 and was last updated on November 3rd, 2022. There is currently a need for 43 individuals at 1 trial site."
Are there any available appointment times for this research program?
"That is correct. The information available on clinicaltrials.gov indicates that the trial is still recruiting patients. According to the site, the study was first posted on September 29th, 2021 and was edited most recently on November 3rd, 2022. They are looking for a total of 43 participants from 1 location."
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