Trial · NCT03094832
Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002)
NCT03094832, Phase 1, Phase 2, Terminated, ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA); results first posted 2023-03-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002). Trials, record NCT03094832. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03094832
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002)
- NCT number
- NCT03094832
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
- Conditions
- PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome
- Interventions
- Miransertib
- First posted
- 2017-03-29
- Last updated
- 2023-04-13
- Other registries' IDs
- eudract:2016-000558-37
- Results first posted
- 2023-03-31
- Limitations and caveats
- Early termination due to business reasons
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 48 months | An AE was defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality. |
| Primary | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 45 months | An AE was defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 48 months | All participants who have received at least one dose of study treatment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 45 months | All participants who have received at least one dose of study treatment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | Part A: Miransertib PROS/PS | 17 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Part B: Miransertib PROS (Cohort 1) | 20 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Part B: Miransertib PS (Cohort 2) | 0 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Part B: Miransertib PROS/PS (Cohort 3) | 6 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Part B:Miransertib Compassionate Use/Expanded Access(Cohort 4) | 1 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Part A: Miransertib PROS/PS | 2 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Part B: Miransertib PROS (Cohort 1) | 0 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Part B: Miransertib PS (Cohort 2) | 0 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Part B: Miransertib PROS/PS (Cohort 3) | 0 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Part B:Miransertib Compassionate Use/Expanded Access(Cohort 4) | 0 | Participants |
Source ClinicalTrials.gov
Participant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Miransertib PROS/PS | 17 | |
| Overall Study | STARTED | Part B: Miransertib PROS (Cohort 1) | 22 | |
| Overall Study | STARTED | Part B: Miransertib PS (Cohort 2) | 1 | |
| Overall Study | STARTED | Part B: Miransertib PROS/PS (Cohort 3) | 8 | |
| Overall Study | STARTED | Part B:Miransertib Compassionate Use/Expanded Access(Cohort 4) | 2 | |
| Overall Study | Treated | Part A: Miransertib PROS/PS | 17 | |
| Overall Study | Treated | Part B: Miransertib PROS (Cohort 1) | 22 | |
| Overall Study | Treated | Part B: Miransertib PS (Cohort 2) | 1 | |
| Overall Study | Treated | Part B: Miransertib PROS/PS (Cohort 3) | 8 | |
| Overall Study | Treated | Part B:Miransertib Compassionate Use/Expanded Access(Cohort 4) | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,065
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 | Anaemia | Blood and lymphatic system disorders | Part A: Miransertib PROS/PS | 2 | 17 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Miransertib PROS (Cohort 1) | 1 | 22 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Miransertib PS (Cohort 2) | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Miransertib PROS/PS (Cohort 3) | 2 | 8 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Miransertib Compassionate Use/Expanded Access (Cohort 4) | 0 | 1 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Part A: Miransertib PROS/PS | 1 | 17 | 2 |
| other | Eosinophilia | Blood and lymphatic system disorders | Part B: Miransertib PROS (Cohort 1) | 0 | 22 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Part B: Miransertib PS (Cohort 2) | 0 | 1 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Part B: Miransertib PROS/PS (Cohort 3) | 2 | 8 | 3 |
| other | Eosinophilia | Blood and lymphatic system disorders | Part B: Miransertib Compassionate Use/Expanded Access (Cohort 4) | 0 | 1 | 0 |
1 to 10 of 1,065Source ClinicalTrials.gov
See all 1,065 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Miransertib PROS/PS | 1 | 17 |
| Total, all-cause mortality | Part B: Miransertib PROS (Cohort 1) | 0 | 22 |
| Total, all-cause mortality | Part B: Miransertib PS (Cohort 2) | 0 | 1 |
| Total, all-cause mortality | Part B: Miransertib PROS/PS (Cohort 3) | 0 | 8 |
| Total, all-cause mortality | Part B: Miransertib Compassionate Use/Expanded Access (Cohort 4) | 0 | 2 |
| Total, other adverse events | Part A: Miransertib PROS/PS | 17 | 17 |
| Total, other adverse events | Part B: Miransertib PROS (Cohort 1) | 18 | 22 |
| Total, other adverse events | Part B: Miransertib PS (Cohort 2) | 0 | 1 |
| Total, other adverse events | Part B: Miransertib PROS/PS (Cohort 3) | 6 | 8 |
| Total, other adverse events | Part B: Miransertib Compassionate Use/Expanded Access (Cohort 4) | 1 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03094832
GET https://conductscience.org/api/trials/v1/NCT03094832/events?page=2