Phase 2
N=16
LAM Pilot Study With Imatinib Mesylate
Lymphangioleiomyomatosis
Bottom Line
View on ClinicalTrials.gov: NCT03131999 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Serum VEGF-D — 0.05; 0.07 Log transformed VEGF-D change pg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Imatinib Mesylate 400Mg Capsule (Drug); Placebo - Capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum VEGF-D |
0.05; 0.07 | — |
| SECONDARY Adverse Events |
10; 12; 0; 0 | — |
Summary
This is a phase 1 clinical trial comparing imatinib mesylate to placebo for individuals with lymphangioleiomyomatosis (LAM).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03131999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.