RecruitingPhase 1Phase 2NCT04941274

Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma

A Phase I/II Study of Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma


Sponsor

National Cancer Institute (NCI)

Enrollment

111 participants

Start Date

Sep 29, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Background: Kaposi Sarcoma (KS) is common in people with human immunodeficiency virus (HIV) but can also occur in people who do not have HIV. KS tumors usually involve the skin, but may also involve lymph nodes, lungs, bone, and gastrointestinal tract. Researchers want to see if a drug that is currently used to treat a type of breast cancer can help. Objective: To find a safe dose of abemaciclib to treat KS and to see if it can shrink lesions or tumors. Eligibility: People ages 18 and older with KS. Design: Participants will be screened with some or all of the following: Medical history Physical exam Blood and urine tests Chest x-ray and/or computed tomography scans Lung or gastrointestinal tract exam with an endoscope (a flexible instrument to examine the interior of the organ) Medicine review Heart function tests KS lesion assessment Skin sample from a KS lesion Treatment will be given in 28-day cycles. Participants will take the study drug tablets by mouth everyday. They will keep a medicine diary. They will get the study drug until their cancer gets worse or they have unacceptable side effects. Participants will have a study visit at the beginning of each cycle. At these visits, they will repeat some screening tests. They may have medical photographs taken of body surfaces. They may complete questionnaires about their quality of life. They may give skin and saliva samples. For skin samples, an area of skin will be numbed. A small circle of skin over an area affected by KS will be removed. Participants will have follow-up visits for up to 2 years after treatment ends.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called abemaciclib (a type of targeted cancer therapy) for Kaposi sarcoma — a cancer that causes lesions on the skin and can affect internal organs — in both HIV-positive and HIV-negative patients. **You may be eligible if...** - You have been diagnosed with Kaposi sarcoma, confirmed by biopsy at the NCI (National Cancer Institute) - You have at least 5 visible, measurable skin lesions from Kaposi sarcoma - You may be HIV-positive or HIV-negative - You are able to swallow oral medication **You may NOT be eligible if...** - Your Kaposi sarcoma has not been confirmed by biopsy - You have fewer than 5 measurable skin lesions - You have serious organ dysfunction (liver, kidney, blood counts below minimum thresholds) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib

An initial dose of 200 mg twice daily and at an MTD dose will be administered orally every day of each 28-day cycle.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT04941274


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