Study on Abemaciclib for Patients with HIV-associated and HIV-negative Kaposi Sarcoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04941274

Provider View

This clinical trial is testing if the drug abemaciclib, used for breast cancer, can safely and effectively treat Kaposi Sarcoma (KS) in adults, whether they have HIV or not. The study aims to find a safe dose and see if it can reduce KS tumors.

Patient Parameters

Program Overview

Kaposi Sarcoma (KS) is a type of cancer that often affects the skin but can also involve other parts of the body like lymph nodes, lungs, and the digestive system. It is more common in people with HIV but can also occur in those without HIV. This study is exploring whether abemaciclib, a drug used for breast cancer, can help treat KS. The main goal is to find a safe dose and see if it can shrink KS tumors in adults aged 18 and older.

Description

Kaposi Sarcoma (KS) is a cancer that usually affects the skin but can also involve other organs. It is more common in people with HIV but can also occur in those without HIV. KS often requires long-term treatment, and new approaches are needed to improve outcomes for patients.

Abemaciclib is a drug that targets specific proteins involved in cell growth and is used to treat breast cancer. Researchers believe it might also help treat KS. This study will test the safety and effectiveness of abemaciclib in people with KS, whether they have been treated before or not.

Participants will take abemaciclib tablets twice daily in 28-day cycles. They will continue treatment until their cancer worsens or they experience unacceptable side effects. Regular visits will include tests and assessments to monitor their health and the drug's effects.

The study is divided into two phases. Phase I will determine a safe dose for people who have had previous KS treatments. Phase II will expand to include more participants, both those who have and have not received prior treatment.

Participants must be 18 or older, have confirmed KS, and meet specific health criteria. They must be able to swallow pills and agree to use contraception if they are of childbearing potential. The study will involve regular follow-up visits for up to two years after treatment ends.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed Kaposi Sarcoma (KS).
  • At least five measurable KS skin lesions with no prior local treatment.
  • Can be HIV positive or negative.
  • Must be able to swallow pills.
  • Must have adequate organ and blood function.
  • For Phase 1: Must have had at least one prior systemic treatment for KS.
  • For Phase 2: Group 2a: Must have had at least one prior systemic treatment for KS. Group 2b: No prior systemic treatment for KS.
  • Must be 18 years or older.
  • Must have a performance status score of 2 or less, indicating they are able to carry out light work.
  • HIV-positive participants must be on effective antiretroviral therapy.
  • Must agree to use contraception if of childbearing potential.
  • Must understand and agree to sign informed consent.

Exclusion Criteria

  • Recent chemotherapy or immunotherapy within 3 weeks before the study.
  • Recent radiotherapy without full recovery.
  • Unresolved side effects from previous cancer treatments.
  • Taking other investigational drugs.
  • Severe allergic reactions to similar drugs.
  • Taking medications that strongly affect liver enzymes.
  • Serious uncontrolled illnesses.
  • Active KSHV-associated diseases.
  • Psychiatric or social issues affecting study participation.
  • Pregnant or breastfeeding individuals.
  • Other cancers that could interfere with the study.
  • Interstitial lung disease.

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