Actively Recruiting
Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-05
111
Participants Needed
1
Research Sites
348 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have Kaposi sarcoma confirmed by pathology
- Measurable disease with at least five cutaneous KS lesions or evaluable disease per RECIST criteria
- Participants may be HIV positive or negative
- Participants must be able to swallow oral medications
- Adequate organ and marrow function as defined by blood counts and liver, kidney, and heart function tests
- For Phase I: at least 1 prior systemic therapy for KS
- For Phase II: groups include those with prior therapy, no prior therapy, and Stage T1 KS with specific symptoms
- Age 18 years or older
- ECOG performance status 0 to 2
- HIV-infected participants must be on effective antiretroviral therapy and willing to adhere to it
- ART must have been received for at least 8 weeks prior to enrollment with no KS improvement in the last 4 weeks
- Participants with controlled hepatitis B or cured hepatitis C infection
- No uncontrolled severe bacterial, viral, or fungal infections
- Cardiac function adequate (ejection fraction > 45%, NYHA class 2B or better)
- Use of effective contraception for those of child-bearing potential during and 4 months after treatment
- Willingness and ability to sign informed consent
You will not qualify if you...
- Chemotherapy or immunotherapy within 3 weeks prior to study entry
- Recent radiotherapy without full recovery; at least 14 days washout required
- Unresolved toxicities from prior cancer therapy greater than grade 1 (except alopecia or neuropathy)
- Receiving any other investigational agents
- History of severe allergic reactions to similar compounds to CDK inhibitors
- Use of strong or moderate CYP3A4 inhibitors without proper dose adjustment
- Serious or uncontrolled illnesses that prevent participation
- Active KSHV-associated multicentric Castleman disease, inflammatory cytokine syndrome, or primary effusion lymphoma
- Psychiatric or social issues limiting study adherence
- Pregnancy
- Interstitial lung disease
- Prior or concurrent malignancies that interfere with safety or efficacy assessments
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Anaida Widell
CONTACT
R
Ramya M Ramaswami, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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