OncoMatch/Clinical Trials/NCT04941274
Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma
Is NCT04941274 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Abemaciclib for kaposi sarcoma.
Treatment: Abemaciclib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Disease stage
Required: Stage STAGE T1 (AIDS Clinical Trials Group Oncology Committee (ACTG))
Stage T1 KS with at least five measurable cutaneous KS lesions per ACTG criteria and/or evaluable disease per RECIST criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — Phase I and Phase II Group 2a: at least 1 prior line of systemic therapy for KS with plateau in response, relapsed disease, progressive disease, or inadequate response to treatment
Phase I: Participants must have received at least 1 prior line of systemic therapy for KS with either plateau in response, progressive disease, or inadequate response to treatment. Phase II: Group 2a: Individuals must have received at least 1 prior line of systemic therapy for KS with either plateau in response, relapsed disease, progressive disease, or inadequate response to treatment
Cannot have received: chemotherapy
Exception: within 3 weeks prior to entering the study
Participants who have had chemotherapy or immunotherapy within 3 weeks prior to entering the study
Cannot have received: immunotherapy
Exception: within 3 weeks prior to entering the study
Participants who have had chemotherapy or immunotherapy within 3 weeks prior to entering the study
Lab requirements
Blood counts
Absolute neutrophil count >1,000/mcL; Platelets >75,000/mcL; Hemoglobin >= 8gm/dL
Kidney function
Creatinine within normal institutional limits OR Creatinine clearance >45 mL/min/1.73 m^2
Liver function
Total bilirubin <= 1.5 upper limit of normal unless receiving a protease inhibitor (e.g. atazanavir), then <= 7.5 mg/dL with direct fraction <= 0.7; AST/ALT <3 X institutional upper limit of normal
Cardiac function
Cardiac ejection fraction > 45% by echocardiogram; NYHA class 2B or better
adequate organ and marrow function as defined below: ... Cardiac ejection fraction > 45% by echocardiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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