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NCT04941274 · ClinicalTrials.gov registry record · Phase 1
Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma
A Phase 1 study of Kaposi Sarcoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
- 1
- Study location
NCT04941274 is a Phase 1 study of Kaposi Sarcoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 86 participants, below the 96-participant average among 13 other Kaposi Sarcoma trials with a reported enrollment target (10% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04941274, a Phase 1 study of Kaposi Sarcoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Conditions Studied
Interventions
- DRUG Abemaciclib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2021-09-29 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04941274
The ClinicalTrials.gov registry entry for NCT04941274 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 96-participant average among 13 other Kaposi Sarcoma trials with a reported enrollment target (10% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Kaposi Sarcoma appearing as the primary indexed condition, and to 1 intervention - of which Abemaciclib is the first listed.
NCT04941274 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04941274 about?
NCT04941274 is a clinical study titled "Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma". 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 curr...
What is the current status of trial NCT04941274?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2021-09-29. Estimated completion is 2028-06-01.
What conditions does trial NCT04941274 study?
This clinical trial studies the following conditions: Kaposi Sarcoma.
What interventions are being tested in trial NCT04941274?
The interventions under investigation include: Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT04941274?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04941274 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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