Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma
Status:
Recruiting
Trial end date:
2028-06-01
Target enrollment:
Participant gender:
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.