LAM Pilot Study With Imatinib Mesylate
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Lymphangioleiomyomatosis
In brief
This is a phase 1 clinical trial comparing imatinib mesylate to placebo for individuals with lymphangioleiomyomatosis (LAM).
Key facts
- Study ID
- NCT03131999
- Run by
- Medical University of South Carolina
- People needed
- 18
- Starts
- 2018-01-23
- Expected to finish
- 2019-03-07
- Last updated by the study team
- 2020-06-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Definite or Probable LAM
- FVC or Postbronchodilator FEV1 <90% predicted
You may not qualify if…
- 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.
Where it is running
- Columbia University — New York, New York, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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