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LAM Pilot Study With Imatinib Mesylate (LAMP-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03131999
Recruitment Status : Completed
First Posted : April 27, 2017
Results First Posted : March 26, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Charlie Strange, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE April 24, 2017
First Posted Date  ICMJE April 27, 2017
Results First Submitted Date  ICMJE February 25, 2020
Results First Posted Date  ICMJE March 26, 2020
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE January 23, 2018
Actual Primary Completion Date March 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
Serum VEGF-D [ Time Frame: Before and 1 month after initiation of monotherapy imatinib mesylate or placebo ]
Change in the square root of the intrasubject plasma VEGF-D
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2020)
Adverse Events [ Time Frame: 3 months ]
Adverse event and Serious Adverse Event numbers using the CTCAE Version 4.03 definitions
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
Adverse events [ Time Frame: 3 months ]
Adverse event and Serious Adverse Event numbers using the CTCAE Version 4.03 definitions
Current Other Pre-specified Outcome Measures
 (submitted: February 25, 2020)
  • Lung Function [ Time Frame: 2 months ]
    FEV1 % predicted change
  • SGRQ [ Time Frame: 2 months ]
    Saint Georges Respiratory Questionnaire change
Original Other Pre-specified Outcome Measures
 (submitted: April 24, 2017)
  • Lung function [ Time Frame: 2 months ]
    FEV1 % predicted change
  • SGRQ [ Time Frame: 2 months ]
    Saint Georges Respiratory Questionnaire change
 
Descriptive Information
Brief Title  ICMJE LAM Pilot Study With Imatinib Mesylate
Official Title  ICMJE LAM Pilot Study With Imatinib Mesylate
Brief Summary This is a phase 1 clinical trial comparing imatinib mesylate to placebo for individuals with lymphangioleiomyomatosis (LAM).
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lymphangioleiomyomatosis
Intervention  ICMJE
  • Drug: Imatinib Mesylate 400Mg Capsule
    Sirolimus or everolimus will be withdrawn after 28 days if used at baseline
    Other Name: Gleevec
  • Drug: Placebo - Capsule
    Sirolimus or everolimus will be withdrawn after 28 days if used at baseline
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Imatinib Mesylate 400mg capsule
    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.
    Intervention: Drug: Imatinib Mesylate 400Mg Capsule
  • Placebo Comparator: Placebo Capsule
    56 days of Placebo with or without co-administration of an mTOR inhibitor for 28 days. A dose reduction is allowed for toxicity.
    Intervention: Drug: Placebo - Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2019)
18
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2017)
20
Actual Study Completion Date  ICMJE March 7, 2019
Actual Primary Completion Date March 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03131999
Other Study ID Numbers  ICMJE PRO00044389
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Charlie Strange, Medical University of South Carolina
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medical University of South Carolina
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Columbia University
Investigators  ICMJE
Study Director: Christopher Meinberg Congressionally Directed Medical Research Programs
PRS Account Medical University of South Carolina
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP