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Trial · NCT03131999

LAM Pilot Study With Imatinib Mesylate

NCT03131999, Phase 1, Phase 2, Completed, Medical University of South Carolina; results first posted 2020-03-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. LAM Pilot Study With Imatinib Mesylate. Trials, record NCT03131999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03131999

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
LAM Pilot Study With Imatinib Mesylate
NCT number
NCT03131999
Status
Completed
Phases
Phase 1, Phase 2
Enrollment
18 participants, actual
Lead sponsor
Medical University of South Carolina
Conditions
Lymphangioleiomyomatosis
Interventions
Imatinib Mesylate 400Mg Capsule, Placebo - Capsule
First posted
2017-04-27
Last updated
2020-06-16
Results first posted
2020-03-26

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySerum VEGF-DBefore and 1 month after initiation of monotherapy imatinib mesylate or placeboChange in the square root of the intrasubject plasma VEGF-D
SecondaryAdverse Events3 monthsAdverse event and Serious Adverse Event numbers using the CTCAE Version 4.03 definitions
OtherLung Function2 monthsFEV1 % predicted change
OtherSGRQ2 monthsSaint Georges Respiratory Questionnaire change

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYSerum VEGF-DBefore and 1 month after initiation of monotherapy imatinib mesylate or placeboLog transformed VEGF-D change pg/dLMEAN
SECONDARYAdverse Events3 monthsnumber of eventsNUMBER
OTHER_PRE_SPECIFIEDLung Function2 months
OTHER_PRE_SPECIFIEDSGRQ2 months

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Serum VEGF-DImatinib Mesylate 400mg Capsule0.05Standard Deviation 0.10Log transformed VEGF-D change pg/dL
Serum VEGF-DPlacebo Capsule0.07Standard Deviation 0.13Log transformed VEGF-D change pg/dL
Adverse EventsImatinib Mesylate 400mg CapsuleAdverse Events10number of events
Adverse EventsPlacebo CapsuleAdverse Events12number of events
Adverse EventsImatinib Mesylate 400mg CapsuleSerious Adverse Events0number of events
Adverse EventsPlacebo CapsuleSerious Adverse Events0number of events

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDImatinib Mesylate 400mg Capsule8
Overall StudySTARTEDPlacebo Capsule8
Overall StudyCOMPLETEDImatinib Mesylate 400mg Capsule8
Overall StudyCOMPLETEDPlacebo Capsule7
Overall StudyNOT COMPLETEDImatinib Mesylate 400mg Capsule0
Overall StudyNOT COMPLETEDPlacebo Capsule1

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherNausea and/or vomittingGastrointestinal disordersImatinib Mesylate 400mg Capsule484
otherNausea and/or vomittingGastrointestinal disordersPlacebo Capsule474
otherFatigueGeneral disordersImatinib Mesylate 400mg Capsule383
otherFatigueGeneral disordersPlacebo Capsule070
otherInsomniaGeneral disordersImatinib Mesylate 400mg Capsule08
otherInsomniaGeneral disordersPlacebo Capsule272
otherHeadacheNervous system disordersImatinib Mesylate 400mg Capsule080
otherHeadacheNervous system disordersPlacebo Capsule373
otherElevated Trough SirolimusRespiratory, thoracic and mediastinal disordersImatinib Mesylate 400mg Capsule282
otherElevated Trough SirolimusRespiratory, thoracic and mediastinal disordersPlacebo Capsule171

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityImatinib Mesylate 400mg Capsule08
Total, all-cause mortalityPlacebo Capsule07
Total, other adverse eventsImatinib Mesylate 400mg Capsule88
Total, other adverse eventsPlacebo Capsule57
Total, serious adverse eventsImatinib Mesylate 400mg Capsule08
Total, serious adverse eventsPlacebo Capsule07

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Imatinib Mesylate 400mg Capsule vs Placebo Capsule: deaths from any causeTrial comparisons
Imatinib Mesylate 400mg Capsule vs Placebo Capsule: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03131999

GET https://conductscience.org/api/trials/v1/NCT03131999/registered