LAM Pilot Study With Imatinib Mesylate

• Status: Completed
• Trial end date: 2019-03-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: Columbia University
• Treatments: Imatinib Mesylate; Sirolimus

Criteria

Inclusion Criteria:

• Definite or Probable LAM

• FVC or Postbronchodilator FEV1 <90% predicted

Exclusion Criteria:

• Current or planned pregnancy or lactation

• Unwillingness to discontinue sirolimus

• Change in the dose or use of sirolimus within the past month

• Inability to perform spirometry

• Allergy or intolerance of albuterol and/or ipratropium

• Other serious illness that would impact the outcome of the study including cancer that has not received curative therapy, Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study), uncontrolled diabetes, chronic renal disease, chronic liver disease, or active uncontrolled infection

• Current lung transplant

• Known diagnosis of human immunodeficiency virus (HIV) infection

• Current cigarette smoking

• Required use of warfarin, ketoconazole, itraconazole, clarithromycin, or rifampin during the 2 months of the study.

• Unwillingness to avoid grapefruit juice or St. Johns Wort during the study.

• Planned surgery during the 2 months of the study.

• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

• Patient has received and other investigational agents within 28 days of first day of study drug dosing.