Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma (NCT04941274) | Clinical Trial Compass
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 range
18 Years – 99 Years
Sex
ALL
See this in plain English?
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-…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
safety and tolerability of abemaciclib
Timeframe: 28 days
2
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