LAM Pilot Study With Imatinib Mesylate

Lymphangioleiomyomatosis Clinical Trial

— LAMP-1  

Official title:

LAM Pilot Study With Imatinib Mesylate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131999
• Other study ID #: PRO00044389
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 23, 2018
• Est. completion date: March 7, 2019

Study information

• Verified date: June 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a double blind, adjusted parallel design, randomized clinical trial comparing imatinib mesylate 400 mg daily or matching placebo on the primary outcome of log transformed serum VEGF-D level in patients with LAM.

Sirolimus using patients will have co-administration of Imatinib mesylate or placebo for 28 days prior to sirolimus discontinuation.

The duration of 400 mg imatinib mesylate or placebo will be 56 days, a dose reduction is allowed for toxicity.

The primary endpoint will be the change in the log transformed VEGF-D one month after monotherapy imatinib mesylate or placebo.

Total trial duration is 2 months of drug administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 7, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphangioleiomyomatosis

Intervention

Drug:
• Imatinib Mesylate 400Mg Capsule
Sirolimus or everolimus will be withdrawn after 28 days if used at baseline
• Placebo - Capsule
Sirolimus or everolimus will be withdrawn after 28 days if used at baseline

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung Function	FEV1 % predicted change	2 months
Other	SGRQ	Saint Georges Respiratory Questionnaire change	2 months
Primary	Serum VEGF-D	Change in the square root of the intrasubject plasma VEGF-D	Before and 1 month after initiation of monotherapy imatinib mesylate or placebo
Secondary	Adverse Events	Adverse event and Serious Adverse Event numbers using the CTCAE Version 4.03 definitions	3 months