LAM Pilot Study With Imatinib Mesylate — LAMP-1  

Lymphangioleiomyomatosis Clinical Trial

Official title: LAM Pilot Study With Imatinib Mesylate

Status Completed

Clinical Trial Summary

This is a phase 1 clinical trial comparing imatinib mesylate to placebo for individuals with lymphangioleiomyomatosis (LAM).

Clinical Trial Description

This is a double blind, adjusted parallel design, randomized clinical trial comparing imatinib mesylate 400 mg daily or matching placebo on the primary outcome of log transformed serum VEGF-D level in patients with LAM.

Sirolimus using patients will have co-administration of Imatinib mesylate or placebo for 28 days prior to sirolimus discontinuation.

The duration of 400 mg imatinib mesylate or placebo will be 56 days, a dose reduction is allowed for toxicity.

The primary endpoint will be the change in the log transformed VEGF-D one month after monotherapy imatinib mesylate or placebo.

Total trial duration is 2 months of drug administration. ;

Related Conditions & MeSH terms

• Lymphangioleiomyomatosis

• NCT number: NCT03131999
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 23, 2018
• Completion date: March 7, 2019