Clinical trial · Interventional
LAM Pilot Study With Imatinib Mesylate
NCT03131999CI-TRIAL-00045536LAMP-1completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 1 clinical trial comparing imatinib mesylate to placebo for individuals with lymphangioleiomyomatosis (LAM).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphangioleiomyomatosis | Lymphangioleiomyomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib Mesylate 400Mg Capsule | Drug | Imatinib | ALIAS |
| Placebo - Capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Imatinib Mesylate 400mg capsule
- description
- 56 days of Imatinib mesylate 400 mg oral daily with or without co-administration of an mTOR inhibitor for 28 days. A dose reduction to 200 mg daily is allowed for toxicity.
- interventionNames
- Drug: Imatinib Mesylate 400Mg Capsule
- type
- PLACEBO_COMPARATOR
- label
- Placebo Capsule
- description
- 56 days of Placebo with or without co-administration of an mTOR inhibitor for 28 days. A dose reduction is allowed for toxicity.
- interventionNames
- Drug: Placebo - Capsule
Primary outcomes (1)
- measure
- Serum VEGF-D
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.