Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a breast cancer drug tame kaposi sarcoma?

NCT ID NCT04941274

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This study tests a drug called abemaciclib, already used for breast cancer, in people with Kaposi sarcoma (KS), both with and without HIV. The goal is to find a safe dose and see if it can shrink KS tumors. About 111 adults will take the drug daily in 28-day cycles until their cancer worsens or side effects become too much.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abemaciclib (a cancer drug taken as tablets)
What this could lead to
If it works, this could offer a new treatment option for Kaposi sarcoma, potentially shrinking tumors and controlling the disease.
What could go wrong
This is an early-phase trial (phase I/II) with only 111 participants, so the drug may not work or may have side effects. It is not a cure, and patients may need ongoing treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 111 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: * Participants must have Kaposi sarcoma confirmed by the Laboratory of Pathology, NCI * Measurable disease as follows: * All participants in Groups 1, 2a, or 2b or 4 should have at least five measurable cutaneous KS lesions per AIDS Clinical Trials Group Oncology Committee (ACTG) criteria with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion and/or evaluable disease per RECIST criteria. * Measurable disease by the criteria proposed by the AIDS Clinical Trials Group Oncology Committee. * Participants in Group 3 must have Stage T1 KS with at least five measurable cutaneous KS lesions per ACTG criteria and/or evaluable disease per RECIST criteria. * Participants may be HIV positive or negative. * Participants must be able to swallow oral medications * For all groups, participants must have adequate organ and marrow function as defined below: * Absolute neutrophil count \>1,000/mcL * Platelets \>75,000/mcL * Hemoglobin \>= 8gm/dL * Total bilirubin \<= 1.5 upper limit of normal unless the participant is receiving a protease inhibitor known to be associated with increased bilirubin (e.g. atazanavir), in which case total bilirubin \<= 7.5 mg/dL with direct fraction \<= 0.7 * AST/ALT \<3 X institutional upper limit of normal * Creatinine within normal institutional limits OR * Creatinine clearance \>45 mL/min/1.73 m\^2 as estimated by either Cockroft-Gault or 24-hour urine collection for participants with creatinine levels above institutional normal * Cardiac ejection fraction \> 45% by echocardiogram * Prior treatment as follows: * 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. Previous local therapy or radiation is not considered systemic therapy. * 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 * Group 2b: Individuals have not received prior systemic therapy for KS. Previous local therapy or radiation is not considered systemic therapy. * Group 3: Evidence of Stage T1 KS with either a) edema or ulcerated KS and/or b) extensive oral KS and/or c) visceral KS involvement * Group 4: Participants that received prior treatment with abemaciclib with evidence of response (at least a partial response per ACTG criteria and/or RECIST) to abemaciclib. * Participants in Cohort 4 must: * have been previously enrolled in Cohorts 1-3 * have at least prior documentation of PR in prior cohort * not have come off treatment for any \>Grade 3 abemaciclib-related AE. * Age \>18 years * Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<= 2 (Karnofsky \>= 60%. * Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy are eligible for this trial. * Willingness to adhere to antiretroviral therapy (ART) * All participants must have received ART for 8 weeks prior to enrollment, with no evidence of KS improvement over the most recent 4 weeks * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV VL must be undetectable on suppressive therapy, if indicated. * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV VL. * No uncontrolled severe concurrent bacterial, viral, or fungal infections. * Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better. * Contraception requirements as follows: * Participants of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (e.g., intrauterine device \[IUD\], hormonal, surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for up to 4 months after completion of abemaciclib administration * Participants able to father a child must with partners of childbearing potential agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment for up to 4 months after completion of abemaciclib administration. Individuals with partners of childbearing potential should ask their partners to be on an effective birth control (hormonal, IUD, surgical sterilization). * Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing person with abemaciclib, nursing should be discontinued if the nursing person is treated with abemaciclib. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants who have had chemotherapy or immunotherapy within 3 weeks prior to entering the study. * Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment. * Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia or neuropathy. * Participants who are receiving any other investigational agents. * History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to CDK inhibitor. * Participants receiving any ART or other medications that are strong/moderate inhibitors of CYP3A4 must have dose reductions per Strong/Moderate CYP3A4 inhibitors. * Serious and/or uncontrolled severe intercurrent illness that in the judgement of the investigator would preclude participation in the study. * No active KSHV-associated multicentric Castleman disease, KSHV-associated inflammatory cytokine syndrome or primary effusion lymphoma. * Psychiatric illness/social situations that would limit adherence with study requirements. * Pregnancy * Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the regimen are eligible for this trial * Participants with interstitial lung disease

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Kaposi sarcoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.