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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Adverse events [ Time Frame: 3 months ]
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