CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Lenalidomidedrug
Likely dose
Lenalidomide 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01057121
NCT01057121Phase 2Completed
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A Phase I/II Study of Lenalidomide in Patients With AIDS-Associated Kaposi's Sarcoma

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2010·Updated Feb 8, 2022

In Brief

A Phase 2 clinical trial evaluating Lenalidomide for AIDS-Related Kaposi Sarcoma and Recurrent Kaposi Sarcoma. Completed, enrolled 38 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAIDS-Related Kaposi Sarcoma, Recurrent Kaposi Sarcoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 27, 2010
Enrollment StartAug 27, 2010
Primary CompletionAug 4, 2014
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 16.4 years ago

Interventions

Lenalidomidedrug

Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles. Sequential cohorts were entered at 10 mg/day, 15 mg/day, 20 mg/day and 25 mg/day using a 3+3 design to determine the MTD