Trial · NCT03319537
Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma
NCT03319537, Phase 1, Phase 2, Terminated, Memorial Sloan Kettering Cancer Center; results first posted 2024-05-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma. Trials, record NCT03319537. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03319537
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma
- NCT number
- NCT03319537
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Mesothelioma
- Interventions
- pevonedistat, Pemetrexed and cisplatin
- First posted
- 2017-10-24
- Last updated
- 2024-05-23
- Results first posted
- 2024-05-23
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 Patients Who Have a Clinical Benefit Rate (CBR) (Cohort 1) | at 18 weeks post initiation of treatment | The CBR is defined as the proportion of patients CR, PR or SD at 18 weeks based on RECIST criteria. |
| Primary | Maximum Tolerated Dose (MTD) (Cohort 2) | 3 year | If none of the initial cohort of 3 has a dose-limited toxicity the dose level will be escalated. If one has a DLT that dose level will be expanded with 3 more patients. Dose escalation will stop if ≥2 DLTs are seen at a dose level. The MTD is defined as the highest dose level at which no more than 1 of the 6 patients at that level has a DLT. If no patient in the 3-patient cohort has a DLT and the dose level is under final consideration of the MTD, an additional three patients will be treated at that level for confirmation. |
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 Patients Who Have a Clinical Benefit Rate (CBR) (Cohort 1) | at 18 weeks post initiation of treatment | No participants accrued to pevonedistat in combination with pemetrexed and cisplatin cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Maximum Tolerated Dose (MTD) (Cohort 2) | 3 year | N/A - Data were not collected |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who Have a Clinical Benefit Rate (CBR) (Cohort 1) | Pevonedistat | Participants who have a Clinical Benefit Rate/CBR | 2 | Participants | |
| Number of Patients Who Have a Clinical Benefit Rate (CBR) (Cohort 1) | Pevonedistat | Participants without a Clinical Benefit Rate/CBR | 7 | Participants |
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 | Pevonedistat | 9 | |
| Overall Study | STARTED | Pevonedistat in Combination With Pemetrexed and Cisplatin | 0 | |
| Overall Study | COMPLETED | Pevonedistat | 9 | |
| Overall Study | COMPLETED | Pevonedistat in Combination With Pemetrexed and Cisplatin | 0 | |
| Overall Study | NOT COMPLETED | Pevonedistat | 0 | |
| Overall Study | NOT COMPLETED | Pevonedistat in Combination With Pemetrexed and Cisplatin | 0 |
Source ClinicalTrials.gov
Adverse events78
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 | Abdominal Pain | Gastrointestinal disorders | Pevonedistat | 2 | 9 | |
| other | Abdominal Pain | Gastrointestinal disorders | Pevonedistat in Combination With Pemetrexed and Cisplatin | 0 | ||
| other | Alanine aminotransferase increased | Investigations | Pevonedistat | 1 | 9 | |
| other | Alanine aminotransferase increased | Investigations | Pevonedistat in Combination With Pemetrexed and Cisplatin | 0 | ||
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Pevonedistat | 1 | 9 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Pevonedistat in Combination With Pemetrexed and Cisplatin | 0 | ||
| other | Anorexia | Metabolism and nutrition disorders | Pevonedistat | 2 | 9 | |
| other | Anorexia | Metabolism and nutrition disorders | Pevonedistat in Combination With Pemetrexed and Cisplatin | 0 | ||
| other | Anxiety | Psychiatric disorders | Pevonedistat | 3 | 9 | |
| other | Anxiety | Psychiatric disorders | Pevonedistat in Combination With Pemetrexed and Cisplatin | 0 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pevonedistat | 8 | 9 |
| Total, all-cause mortality | Pevonedistat in Combination With Pemetrexed and Cisplatin | 0 | 0 |
| Total, other adverse events | Pevonedistat | 7 | 9 |
| Total, other adverse events | Pevonedistat in Combination With Pemetrexed and Cisplatin | 0 | 0 |
| Total, serious adverse events | Pevonedistat | 3 | 9 |
| Total, serious adverse events | Pevonedistat in Combination With Pemetrexed and Cisplatin | 0 | 0 |
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 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/NCT03319537
GET https://conductscience.org/api/trials/v1/NCT03319537/events?page=2