NCT04941274

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

Recruiting now Phase 1, PHASE2 Last updated 23 January 2026

What this trial tests

Phase 1, PHASE2 trial testing Abemaciclib in Kaposi Sarcoma in 86 participants. Currently enrolling.

Timeline

29 September 2021

Primary endpoint
1 March 2028

1 June 2028

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	86
Start date	29 September 2021
Primary completion	1 March 2028
Estimated completion	1 June 2028
Sites	1 location across United States

Drugs / interventions tested

• Abemaciclib (abemaciclib) — full drug profile →

Conditions studied

• Kaposi Sarcoma — all drugs for Kaposi Sarcoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Kaposi Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Viral oncogenesis in cancer: from mechanisms to therapeutics.
   Xiao Q, Liu Y, Li T, Wang C, et al · · 2025 · cited 45× · PMID 40350456 · DOI 10.1038/s41392-025-02197-9
2. CDK4/6 inhibitors sensitize gammaherpesvirus-infected tumor cells to T-cell killing by enhancing expression of immune surface molecules.
   Wu Y, Shrestha P, Heape NM, Yarchoan R. · · 2022 · cited 17× · PMID 35562811 · DOI 10.1186/s12967-022-03400-z
3. The Role of CDK Pathway Dysregulation and Its Therapeutic Potential in Soft Tissue Sarcoma.
   Thiel JT, Daigeler A, Kolbenschlag J, Rachunek K, et al · · 2022 · cited 14× · PMID 35884441 · DOI 10.3390/cancers14143380
4. Classic Kaposi sarcoma: Diagnostics, treatment modalities, and genetic implications - A review of the literature.
   Batash R, Crimí A, Kassem R, Asali M, et al · · 2024 · cited 6× · PMID 39415564 · DOI 10.2340/1651-226x.2024.40537
5. Management and Future Therapeutic Perspectives of Classic Kaposi's Sarcoma: An Evidence-Based Review.
   Denaro N, Indini A, Brambilla L, Marzano AV, et al · · 2024 · cited 2× · PMID 39530040 · DOI 10.2147/ott.s468787
6. Targeting cyclin-dependent kinases in sarcoma treatment: Current perspectives and future directions.
   Merlini A, Pavese V, Manessi G, Rabino M, et al · · 2023 · cited 1× · PMID 36741019 · DOI 10.3389/fonc.2023.1095219
7. Classic Kaposi Sarcoma: Current Treatment Strategies and Emerging Therapeutic Approaches.
   Revenko D, Shirron N, Shainer R, Avitan-Hersh E, et al · · 2026 · PMID 41899609 · DOI 10.3390/cancers18061008