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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum VEGF-D | Before and 1 month after initiation of monotherapy imatinib mesylate or placebo | Change in the square root of the intrasubject plasma VEGF-D |
| Secondary | Adverse Events | 3 months | Adverse event and Serious Adverse Event numbers using the CTCAE Version 4.03 definitions |
| Other | Lung Function | 2 months | FEV1 % predicted change |
| Other | SGRQ | 2 months | Saint Georges Respiratory Questionnaire change |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serum VEGF-D | Before and 1 month after initiation of monotherapy imatinib mesylate or placebo | Log transformed VEGF-D change pg/dL | MEAN | |
| SECONDARY | Adverse Events | 3 months | number of events | NUMBER | |
| OTHER_PRE_SPECIFIED | Lung Function | 2 months | |||
| OTHER_PRE_SPECIFIED | SGRQ | 2 months |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serum VEGF-D | Imatinib Mesylate 400mg Capsule | 0.05 | Standard Deviation 0.10 | Log transformed VEGF-D change pg/dL | |
| Serum VEGF-D | Placebo Capsule | 0.07 | Standard Deviation 0.13 | Log transformed VEGF-D change pg/dL | |
| Adverse Events | Imatinib Mesylate 400mg Capsule | Adverse Events | 10 | number of events | |
| Adverse Events | Placebo Capsule | Adverse Events | 12 | number of events | |
| Adverse Events | Imatinib Mesylate 400mg Capsule | Serious Adverse Events | 0 | number of events | |
| Adverse Events | Placebo Capsule | Serious Adverse Events | 0 | number of events |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imatinib Mesylate 400mg Capsule | 8 | |
| Overall Study | STARTED | Placebo Capsule | 8 | |
| Overall Study | COMPLETED | Imatinib Mesylate 400mg Capsule | 8 | |
| Overall Study | COMPLETED | Placebo Capsule | 7 | |
| Overall Study | NOT COMPLETED | Imatinib Mesylate 400mg Capsule | 0 | |
| Overall Study | NOT COMPLETED | Placebo Capsule | 1 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea and/or vomitting | Gastrointestinal disorders | Imatinib Mesylate 400mg Capsule | 4 | 8 | 4 |
| other | Nausea and/or vomitting | Gastrointestinal disorders | Placebo Capsule | 4 | 7 | 4 |
| other | Fatigue | General disorders | Imatinib Mesylate 400mg Capsule | 3 | 8 | 3 |
| other | Fatigue | General disorders | Placebo Capsule | 0 | 7 | 0 |
| other | Insomnia | General disorders | Imatinib Mesylate 400mg Capsule | 0 | 8 | |
| other | Insomnia | General disorders | Placebo Capsule | 2 | 7 | 2 |
| other | Headache | Nervous system disorders | Imatinib Mesylate 400mg Capsule | 0 | 8 | 0 |
| other | Headache | Nervous system disorders | Placebo Capsule | 3 | 7 | 3 |
| other | Elevated Trough Sirolimus | Respiratory, thoracic and mediastinal disorders | Imatinib Mesylate 400mg Capsule | 2 | 8 | 2 |
| other | Elevated Trough Sirolimus | Respiratory, thoracic and mediastinal disorders | Placebo Capsule | 1 | 7 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imatinib Mesylate 400mg Capsule | 0 | 8 |
| Total, all-cause mortality | Placebo Capsule | 0 | 7 |
| Total, other adverse events | Imatinib Mesylate 400mg Capsule | 8 | 8 |
| Total, other adverse events | Placebo Capsule | 5 | 7 |
| Total, serious adverse events | Imatinib Mesylate 400mg Capsule | 0 | 8 |
| Total, serious adverse events | Placebo Capsule | 0 | 7 |
Source ClinicalTrials.gov
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.
| Comparison | Source |
|---|---|
| Imatinib Mesylate 400mg Capsule vs Placebo Capsule: deaths from any cause | Trial comparisons |
| Imatinib Mesylate 400mg Capsule vs Placebo Capsule: serious adverse events | Trial 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.
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