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NCT01495598 · ClinicalTrials.gov registry record · Phase 1
Pomalidomide for Kaposi Sarcoma in People With or Without HIV
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01495598: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01495598 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01495598, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Background: \- Pomalidomide is a drug that can treat cancer through several mechanisms. It is taken by mouth (orally). Pomalidomide can help treat cancer by blocking certain factors that promote tumor growth or by stimulating the immune system to attack tumor cells. It also prevents the growth of new blood vessels that help cancer grow. Researchers want to see if pomalidomide can treat Kaposi sarcoma, a rare and potentially fatal skin cancer. Because Kaposi sarcoma may be associated with human immunodeficiency virus (HIV) infection, researchers want to test the drug in people with and without HIV infection. Objectives: \- To see if pomalidomide is a safe and effective treatment for Kaposi sarcoma in people with or without HIV. Eligibility: * Individuals at least 18 years of age who have Kaposi sarcoma. * Participants may or may not have HIV infection. Design: * Potential participants will be screened with a medical history and physical exam. Blood and saliva samples will be taken and a chest X-ray will be performed. A skin biopsy of a Kaposi sarcoma lesion may be performed if one has not already been done. Other imaging studies may be performed if needed. * Participants will take pomalidomide capsules every day for 3 weeks, followed by a 1-week break. These 28 days are one cycle of treatment. * Participants will have up six cycles of treatment, unless the lesions completely resolve sooner. If there are signs of improvement after six cycles but the lesions are not completely gone, up to another six cycles of treatment may be given. * Treatment will be monitored with frequent blood tests and other studies including photograph and other imaging of skin lesions. * Participants will have regular follow-up visits for 5 years after stopping treatment....
Primary Outcome
Adverse events (AE's) that are possibly, probably, and/or definitely attributed to pomalidomide were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening.
Interventions
- DRUG Pomalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-01-10 |
| Est. Completion | 2022-05-17 |
| Phase | Phase 1 |
What the finished NCT01495598 record still lists
NCT01495598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Pomalidomide is the first listed.
NCT01495598 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01495598 about?
NCT01495598 is a clinical study titled "Pomalidomide for Kaposi Sarcoma in People With or Without HIV". Background: \- Pomalidomide is a drug that can treat cancer through several mechanisms. It is taken by mouth (orally). Pomalidomide can help treat cancer by blocking certain factors that promote tumor growth or by stimulating the immune system to attack tumor cells. It also prevents the growth of n...
What is the current status of trial NCT01495598?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2012-01-10. Estimated completion is 2022-05-17.
What interventions are being tested in trial NCT01495598?
The interventions under investigation include: Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT01495598?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01495598's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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