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NCT01057121 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma
A Phase 1 study of Recurrent Kaposi Sarcoma and AIDS-Related Kaposi Sarcoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 13
- Study locations
NCT01057121: Completed Phase 1 study of Recurrent Kaposi Sarcoma and AIDS-Related Kaposi Sarcoma, sponsored by National Cancer Institute (NCI).
NCT01057121 is a Phase 1 study of Recurrent Kaposi Sarcoma and AIDS-Related Kaposi Sarcoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01057121, a Phase 1 study of Recurrent Kaposi Sarcoma and AIDS-Related Kaposi Sarcoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 13
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of lenalidomide and to see how well it works in treating patients with acquired immunodeficiency syndrome (AIDS)-related Kaposi sarcoma (KS). Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor.
Primary Outcome
Maximum tolerated dose (MTD) of lenalidomide defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the MTD is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the f
Conditions Studied
Interventions
- DRUG Lenalidomide
Study Locations (13)
California
- UCLA Center for Clinical AIDS Research and Education - Los Angeles
- University of California San Diego - San Diego
- San Francisco General Hospital - San Francisco
Washington
- Virginia Mason Medical Center - Seattle
- Harborview Medical Center - Seattle
Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
Hawaii
- Cancer Center of Hawaii-Hawaii AIDS Clinical Research Program - Honolulu
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital - Baltimore
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
New York
- Memorial Sloan-Kettering Cancer Center - New York
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-08-27 |
| Est. Completion | 2014-08-04 |
| Phase | Phase 1 |
What the finished NCT01057121 record still lists
NCT01057121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 2 conditions, with Recurrent Kaposi Sarcoma appearing as the primary indexed condition, and to 1 intervention - of which Lenalidomide is the first listed.
NCT01057121 lists 13 locations in 10 states (California, Washington, Florida).
Frequently Asked Questions
What is clinical trial NCT01057121 about?
NCT01057121 is a clinical study titled "Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma". This phase I/II trial studies the side effects and best dose of lenalidomide and to see how well it works in treating patients with acquired immunodeficiency syndrome (AIDS)-related Kaposi sarcoma (KS). Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor.
What is the current status of trial NCT01057121?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2010-08-27. Estimated completion is 2014-08-04.
What conditions does trial NCT01057121 study?
This clinical trial studies the following conditions: Recurrent Kaposi Sarcoma, AIDS-Related Kaposi Sarcoma.
What interventions are being tested in trial NCT01057121?
The interventions under investigation include: Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT01057121?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01057121 being conducted?
This trial has 13 study locations across California, Florida, Hawaii, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01057121's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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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