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

Recruiting now · Phase 1/Phase 2

Conditions studied: Kaposi Sarcoma

In brief

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 who stopped taking abemaciclib because it was no longer providing additional benefit may be able to restart abemaciclib again. 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.

Key facts

Study ID

NCT04941274

Run by

National Cancer Institute (NCI)

People needed

111

Starts

2021-09-29

Expected to finish

2028-06-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Participants who have had chemotherapy or immunotherapy within 3 weeks prior to entering the study.
• Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment.
• Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia or neuropathy.
• Participants who are receiving any other investigational agents.
• History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to CDK inhibitor.
• Participants receiving any ART or other medications that are strong/moderate inhibitors of CYP3A4 must have dose reductions per Strong/Moderate CYP3A4 inhibitors.
• Serious and/or uncontrolled severe intercurrent illness that in the judgement of the investigator would preclude participation in the study.
• No active KSHV-associated multicentric Castleman disease, KSHV-associated inflammatory cytokine syndrome or primary effusion lymphoma.
• Psychiatric illness/social situations that would limit adherence with study requirements.
• Pregnancy
• Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the regimen are eligible for this trial
• Participants with interstitial lung disease

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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