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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04941274
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Kaposi Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    An initial dose of 200 mg twice daily and at an MTD dose will be administered orally every day of each 28-day cycle.

Study Details

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.

Key Dates

Start date
Sep 29, 2021
Status verified
May 2026
Primary completion
Mar 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
111 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1/Dose Determination/De-Escalation
    Abemaciclib (de-escalating dose)
  • Experimental: 2/Dose Expansion: Group 2a
    Abemaciclib (at optimal dose determined in dose escalation portion of the study) for up to 15 participants previously treated with at least 1 line of systemic therapy.
  • Experimental: 3/Dose Expansion: Group 2b
    Abemaciclib (at optimal dose determined in dose escalation portion of the study) for up to 10 previously untreated participants.
  • Experimental: 4/Dose Expansion: Group 3
    Abemaciclib (at optimal dose determined in dose escalation portion of the study or adjusted for CYP3A4 inhibitor use) for up to 23 participants with Stage T1 KS
  • Experimental: 5/Re-treatment
    Abemaciclib at the last safe and active dose or adjusted for CYP3A4 inhibitor use

Primary Outcome Measure

safety and tolerability of abemaciclib [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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