Trial · NCT02357147
Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM)
NCT02357147, Phase 2, Terminated, Morphotek; results first posted 2020-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM). Trials, record NCT02357147. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02357147
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM)
- NCT number
- NCT02357147
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Morphotek
- Conditions
- Mesothelioma, Malignant
- Interventions
- Placebo, Amatuximab, Pemetrexed, Cisplatin
- First posted
- 2015-02-06
- Last updated
- 2020-03-17
- Other registries' IDs
- eudract:2014-004489-85
- Results first posted
- 2020-03-17
- Limitations and caveats
- The study was terminated due to business decision. No safety concerns involved in decision to terminate this study.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 3 years | AEs included both non-SAEs and SAEs and the same participant can have both SAEs and as well non-SAEs. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 3 years | The safety analysis set was defined as all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin | AEs | 50 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin | AEs | 52 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Maintenance Treatment Phase: Amatuximab | AEs | 19 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Maintenance Treatment Phase: Placebo | AEs | 21 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin | SAEs | 15 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin | SAEs | 11 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Maintenance Treatment Phase: Amatuximab | SAEs | 1 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Maintenance Treatment Phase: Placebo | SAEs | 4 | Participants |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Combination Treatment Phase | STARTED | Amatuximab + Pemetrexed + Cisplatin | 52 | |
| Combination Treatment Phase | STARTED | Placebo + Pemetrexed + Cisplatin | 56 | |
| Combination Treatment Phase | Treated | Amatuximab + Pemetrexed + Cisplatin | 52 | |
| Combination Treatment Phase | Treated | Placebo + Pemetrexed + Cisplatin | 54 | |
| Combination Treatment Phase | COMPLETED | Amatuximab + Pemetrexed + Cisplatin | 26 | |
| Combination Treatment Phase | COMPLETED | Placebo + Pemetrexed + Cisplatin | 29 | |
| Combination Treatment Phase | NOT COMPLETED | Amatuximab + Pemetrexed + Cisplatin | 26 | |
| Combination Treatment Phase | NOT COMPLETED | Placebo + Pemetrexed + Cisplatin | 27 | |
| Maintenance Treatment Phase | STARTED | Amatuximab + Pemetrexed + Cisplatin | 26 | |
| Maintenance Treatment Phase | STARTED | Placebo + Pemetrexed + Cisplatin | 29 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events380
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 | Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin | 11 | 52 | 29 |
| other | Anaemia | Blood and lymphatic system disorders | Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin | 12 | 54 | 21 |
| other | Anaemia | Blood and lymphatic system disorders | Maintenance Treatment Phase: Amatuximab | 3 | 25 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Maintenance Treatment Phase: Placebo | 2 | 29 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin | 3 | 52 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin | 1 | 54 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Maintenance Treatment Phase: Amatuximab | 0 | 25 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Maintenance Treatment Phase: Placebo | 0 | 29 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin | 13 | 52 | 35 |
| other | Neutropenia | Blood and lymphatic system disorders | Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin | 10 | 54 | 28 |
1 to 10 of 380Source ClinicalTrials.gov
See all 380 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin | 6 | 52 |
| Total, all-cause mortality | Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin | 3 | 54 |
| Total, all-cause mortality | Maintenance Treatment Phase: Amatuximab | 2 | 25 |
| Total, all-cause mortality | Maintenance Treatment Phase: Placebo | 1 | 29 |
| Total, other adverse events | Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin | 50 | 52 |
| Total, other adverse events | Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin | 51 | 54 |
| Total, other adverse events | Maintenance Treatment Phase: Amatuximab | 19 | 25 |
| Total, other adverse events | Maintenance Treatment Phase: Placebo | 21 | 29 |
| Total, serious adverse events | Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin | 15 | 52 |
| Total, serious adverse events | Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin | 11 | 54 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 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/NCT02357147
GET https://conductscience.org/api/trials/v1/NCT02357147/events?page=2