Spots Global Cancer Trial Database for LAM Pilot Study With Imatinib Mesylate

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Trial Identification

Brief Title: LAM Pilot Study With Imatinib Mesylate

Official Title: LAM Pilot Study With Imatinib Mesylate

Study ID: NCT03131999

Conditions

Lymphangioleiomyomatosis

Interventions

Imatinib Mesylate 400Mg Capsule

Placebo - Capsule

Study Description

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

Detailed 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.