LAM Pilot Study With Imatinib Mesylate

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03131999
• Date of registration: 24/04/2017
• Prospective Registration: Yes
• Primary sponsor: Medical University of South Carolina
• Public title: LAM Pilot Study With Imatinib Mesylate LAMP-1
• Scientific title: LAM Pilot Study With Imatinib Mesylate
• Date of first enrolment: January 23, 2018
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03131999
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Christopher Meinberg
• Affiliation: Congressionally Directed Medical Research Programs

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lymphangioleiomyomatosis

Intervention(s)

Drug: Imatinib Mesylate 400Mg Capsule

Drug: Placebo - Capsule

Primary Outcome(s)

Serum VEGF-D [Time Frame: Before and 1 month after initiation of monotherapy imatinib mesylate or placebo]

Secondary Outcome(s)

Adverse Events [Time Frame: 3 months]

Secondary ID(s)

PRO00044389

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Columbia University

Results

• Results available: Yes
• Date Posted: 26/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03131999