Trial · NCT04175912
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
NCT04175912, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver. Trials, record NCT04175912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04175912
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
- NCT number
- NCT04175912
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8, Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIB Hepatocellular Carcinoma AJCC v8, Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Stage IVA Hepatocellular Carcinoma AJCC v8, Stage IVB Hepatocellular Carcinoma AJCC v8, Unresectable Cholangiocarcinoma, Unresectable Hepatocellular Carcinoma, Unresectable Intrahepatic Cholangiocarcinoma
- Interventions
- Carboplatin, Paclitaxel, Pevonedistat
- First posted
- 2019-11-25
- Last updated
- 2026-10-26
- Results first posted
- 2025-01-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response | Every 3 months for the first year and every 6 months for years 2-3 | Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Objective response includes complete response (CR) and partial response (PR). CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Clinical Benefit | Every 3 months for the first year and every 6 months for years 2-3 | Clinical benefit was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), including complete response (CR), partial response (PR) and stable disease (SD) that lasted greater than or equal to 24 weeks. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
| Secondary | Progression-free Survival (PFS) | Every 3 months for the first year and every 6 months for years 2-3 | PFS was defined as the time from randomization to progression or death, whichever came first; patients alive without evidence of disease progression were censored at the date of last disease assessment. Patients who died without documented progression and the death occurred \> 6 weeks of last disease assessment will be censored at the date of last disease assessment that showed progression-free. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered as progression. |
| Secondary | Overall Survival (OS) | Every 3 months for the first year and every 6 months for years 2-3 | OS was defined as the time from randomization to death from any cause, and patients still living were censored at the date last known alive. |
| Other | Associations Between Response and Overexpression of NEDD8, NAE1, and UBC12 | Assessed every 3 months for the first year and every 6 months for years 2-3 | Associations between response and overexpression of NEDD8, NAE1, and UBC12 will be evaluated. |
| Other | Mutation Profile of Those Cholangiocarcinomas | Assessed at baseline | To identify the mutation profile of those cholangiocarcinomas with overexpression of the neddylation pathway |
| Other | Specimens Banking | Baseline | To bank specimens for further future investigations |
| Other | Incidence of Adverse Event | Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response | Every 3 months for the first year and every 6 months for years 2-3 | Eligible and treated patients are included in this analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit | Every 3 months for the first year and every 6 months for years 2-3 | Eligible and treated patients are included in this analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) | Every 3 months for the first year and every 6 months for years 2-3 | Eligible and treated patients are included in this analysis | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Every 3 months for the first year and every 6 months for years 2-3 | Eligible and treated patients are included in this analysis | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Associations Between Response and Overexpression of NEDD8, NAE1, and UBC12 | Assessed every 3 months for the first year and every 6 months for years 2-3 | |||
| OTHER_PRE_SPECIFIED | Mutation Profile of Those Cholangiocarcinomas | Assessed at baseline | |||
| OTHER_PRE_SPECIFIED | Specimens Banking | Baseline | |||
| OTHER_PRE_SPECIFIED | Incidence of Adverse Event | Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response | Arm A (Pevonedistat) | With Objective Response | 0 | Participants | |
| Objective Response | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | With Objective Response | 0 | Participants | |
| Objective Response | Arm A (Pevonedistat) | Without Objective Response | 17 | Participants | |
| Objective Response | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | Without Objective Response | 17 | Participants | |
| Clinical Benefit | Arm A (Pevonedistat) | With Clinical Benefit | 0 | Participants | |
| Clinical Benefit | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | With Clinical Benefit | 1 | Participants | |
| Clinical Benefit | Arm A (Pevonedistat) | Without Clinical Benefit | 17 | Participants | |
| Clinical Benefit | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | Without Clinical Benefit | 16 | Participants | |
| Progression-free Survival (PFS) | Arm A (Pevonedistat) | 1.54 | 95% Confidence Interval 1.41 to 2.10 | months | |
| Progression-free Survival (PFS) | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 2.92 | 95% Confidence Interval 1.71 to 5.55 | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Pevonedistat) | 20 | |
| Overall Study | STARTED | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 20 | |
| Overall Study | Received Treatment | Arm A (Pevonedistat) | 17 | |
| Overall Study | Received Treatment | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 17 | |
| Overall Study | Eligible and Treated | Arm A (Pevonedistat) | 17 | |
| Overall Study | Eligible and Treated | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 17 | |
| Overall Study | COMPLETED | Arm A (Pevonedistat) | 0 | |
| Overall Study | COMPLETED | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 0 | |
| Overall Study | NOT COMPLETED | Arm A (Pevonedistat) | 20 | |
| Overall Study | NOT COMPLETED | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 20 |
Source ClinicalTrials.gov
Adverse events352
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 | Hearing impaired | Ear and labyrinth disorders | Arm A (Pevonedistat) | 0 | 17 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 1 | 17 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm A (Pevonedistat) | 0 | 17 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 1 | 17 | |
| other | Vertigo | Ear and labyrinth disorders | Arm A (Pevonedistat) | 0 | 17 | |
| other | Vertigo | Ear and labyrinth disorders | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 1 | 17 | |
| other | Anemia | Blood and lymphatic system disorders | Arm A (Pevonedistat) | 7 | 17 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 11 | 17 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Arm A (Pevonedistat) | 0 | 17 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 1 | 17 |
1 to 10 of 352Source ClinicalTrials.gov
See all 352 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Pevonedistat) | 17 | 17 |
| Total, all-cause mortality | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 15 | 17 |
| Total, other adverse events | Arm A (Pevonedistat) | 17 | 17 |
| Total, other adverse events | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 17 | 17 |
| Total, serious adverse events | Arm A (Pevonedistat) | 8 | 17 |
| Total, serious adverse events | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 12 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39932259 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Pevonedistat) vs Arm B (Pevonedistat, Paclitaxel, Carboplatin): deaths from any cause | Trial comparisons |
| Arm A (Pevonedistat) vs Arm B (Pevonedistat, Paclitaxel, Carboplatin): 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/NCT04175912
GET https://conductscience.org/api/trials/v1/NCT04175912/events?page=2