Clinical Trial: LAM Pilot Study With Imatinib Mesylate

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: LAM Pilot Study With Imatinib Mesylate

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

Detailed Summary:

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.


Sponsor: Medical University of South Carolina

Current Primary Outcome: Serum VEGF-D [ Time Frame: Before and 1 month after initiation of monotherapy imatinib mesylate or placebo ]

Change in the square root of the intrasubject plasma VEGF-D


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse events [ Time Frame: 3 months ]

Adverse event and Serious Adverse Event numbers using the CTCAE Version 4.03 definitions


Original Secondary Outcome: Same as current

Information By: Medical University of South Carolina

Dates:
Date Received: April 24, 2017
Date Started: June 1, 2017
Date Completion: June 30, 2018
Last Updated: April 27, 2017
Last Verified: April 2017