RecruitingPhase 1/2

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

United States111 participantsStarted 2021-09-29

Plain-language 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 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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-…

What they're measuring

safety and tolerability of abemaciclib

Timeframe: 28 days

overall response rate

Timeframe: every 3 cycles until completion of therapy, then every 3 months for 6 months, then every 6 months for 2 years, then annually for 2 years

Trial details

NCT IDNCT04941274

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2028-03-01

Contact for this trial

Anaida Widell

(240) 760-6074 anaida.widell@nih.gov