Trial · NCT02101021
Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
NCT02101021, Phase 3, Terminated, Sierra Oncology LLC - a GSK company; results first posted 2018-05-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma. Trials, record NCT02101021. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02101021
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
- NCT number
- NCT02101021
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 25 participants, actual
- Lead sponsor
- Sierra Oncology LLC - a GSK company
- Conditions
- Metastatic Pancreatic Ductal Adenocarcinoma
- Interventions
- Momelotinib, Placebo to match momelotinib, Nab-paclitaxel, Gemcitabine
- First posted
- 2014-04-01
- Last updated
- 2023-06-29
- Other registries' IDs
- eudract:2014-004480-20
- Results first posted
- 2018-05-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events | Up to 28 Days | Dose limiting toxicities were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting toxicities referred to toxicities experienced during the first 28 days (Cycle 1) of treatment that were judged to be clinically significant and related to study treatment. No statistical analysis was planned or performed for this endpoint. |
| Primary | Randomized Treatment Phase: Overall Survival (OS) | Baseline up to the Date of Death or Censoring, up to 3 years | Overall survival was defined as the time interval from first dose date of MMB to death from any cause |
| Secondary | Lead-In Phase: Overall Survival (OS) | Baseline up to the Date of Death or Censoring, up to 3 years | Overall survival was defined as the time interval from first dose date of MMB to death from any cause |
| Secondary | Lead-In Phase: Progression-Free Survival (PFS) | Baseline up to the Date of Event or Censoring, up to 3 years | Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression is progression based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1. Data from survival, non-progressing participants will be censored at the earliest of the time of initiation of anti-tumor therapy other than the study treatment or the last time that lack of definitive disease progression was objectively documented while on study. |
| Secondary | Lead-In Phase: Overall Response Rate (ORR) | Baseline up to the Last Tumor Assessment Date, up to 3 years | The ORR was defined as the proportion of participants who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR) as assessed by RECIST v1.1. |
| Secondary | Randomized Treatment Phase: Progression-Free Survival (PFS) | Baseline up to the Date of Event or Censoring, up to 3 years | Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause |
| Secondary | Randomized Treatment Phase: Overall Response Rate | Baseline up to the Last Tumor Assessment Date, up to 3 years | The ORR was defined as the proportion of subjects who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events | Up to 28 Days | DLT-Evaluable Analysis Set: participants in the Safety Analysis Set who completed all treatment and safety procedures through Day 28, inclusive, or experienced a DLT prior to Day 29. Participants in the DLT-Evaluable Analysis Set with available data were analyzed. | percentage of participants | NUMBER |
| PRIMARY | Randomized Treatment Phase: Overall Survival (OS) | Baseline up to the Date of Death or Censoring, up to 3 years | The study was discontinued before initiation of the randomized treatment phase. | ||
| SECONDARY | Lead-In Phase: Overall Survival (OS) | Baseline up to the Date of Death or Censoring, up to 3 years | All Enrolled Analysis Set | Months | MEDIAN |
| SECONDARY | Lead-In Phase: Progression-Free Survival (PFS) | Baseline up to the Date of Event or Censoring, up to 3 years | All Enrolled Analysis Set | Months | MEDIAN |
| SECONDARY | Lead-In Phase: Overall Response Rate (ORR) | Baseline up to the Last Tumor Assessment Date, up to 3 years | All Enrolled Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Randomized Treatment Phase: Progression-Free Survival (PFS) | Baseline up to the Date of Event or Censoring, up to 3 years | The study was discontinued before initiation of the randomized treatment phase. | ||
| SECONDARY | Randomized Treatment Phase: Overall Response Rate | Baseline up to the Last Tumor Assessment Date, up to 3 years | The study was discontinued before initiation of the randomized treatment phase. |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events | MMB Dose Level 1 | 16.7 | percentage of participants | ||
| Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events | MMB Dose Level 2 | 0 | percentage of participants | ||
| Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events | MMB Dose Level 3 | 16.7 | percentage of participants | ||
| Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events | MMB Dose Level 4 | 0 | percentage of participants | ||
| Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events | MMB Dose Level 5 | 0 | percentage of participants | ||
| Lead-In Phase: Overall Survival (OS) | MMB Dose Level 1 | 12.4 | Inter-Quartile Range 3.9 to 22.2 | Months | |
| Lead-In Phase: Overall Survival (OS) | MMB Dose Level 2 | 5.1 | Inter-Quartile Range 3.7 to 11.3 | Months | |
| Lead-In Phase: Overall Survival (OS) | MMB Dose Level 3 | 8.7 | Inter-Quartile Range 7.3 to 18.3 | Months | |
| Lead-In Phase: Overall Survival (OS) | MMB Dose Level 4 | 5.6 | Inter-Quartile Range 4.8 to 18.1 | Months | |
| Lead-In Phase: Overall Survival (OS) | MMB Dose Level 5 | 7.1 | Inter-Quartile Range 5.9 to 12.0 | Months |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MMB Dose Level 1 | 7 | |
| Overall Study | STARTED | MMB Dose Level 2 | 4 | |
| Overall Study | STARTED | MMB Dose Level 3 | 7 | |
| Overall Study | STARTED | MMB Dose Level 4 | 3 | |
| Overall Study | STARTED | MMB Dose Level 5 | 4 | |
| Overall Study | COMPLETED | MMB Dose Level 1 | 0 | |
| Overall Study | COMPLETED | MMB Dose Level 2 | 0 | |
| Overall Study | COMPLETED | MMB Dose Level 3 | 0 | |
| Overall Study | COMPLETED | MMB Dose Level 4 | 0 | |
| Overall Study | COMPLETED | MMB Dose Level 5 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,125
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 | MMB Dose Level 1 | 6 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | MMB Dose Level 2 | 2 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | MMB Dose Level 3 | 4 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | MMB Dose Level 4 | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | MMB Dose Level 5 | 3 | 4 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | MMB Dose Level 1 | 0 | 7 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | MMB Dose Level 2 | 0 | 4 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | MMB Dose Level 3 | 0 | 7 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | MMB Dose Level 4 | 0 | 3 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | MMB Dose Level 5 | 1 | 4 |
1 to 10 of 1,125Source ClinicalTrials.gov
See all 1,125 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MMB Dose Level 1 | 4 | 7 |
| Total, all-cause mortality | MMB Dose Level 2 | 3 | 4 |
| Total, all-cause mortality | MMB Dose Level 3 | 6 | 7 |
| Total, all-cause mortality | MMB Dose Level 4 | 0 | 3 |
| Total, all-cause mortality | MMB Dose Level 5 | 3 | 4 |
| Total, other adverse events | MMB Dose Level 1 | 7 | 7 |
| Total, other adverse events | MMB Dose Level 2 | 4 | 4 |
| Total, other adverse events | MMB Dose Level 3 | 7 | 7 |
| Total, other adverse events | MMB Dose Level 4 | 3 | 3 |
| Total, other adverse events | MMB Dose Level 5 | 4 | 4 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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/NCT02101021
GET https://conductscience.org/api/trials/v1/NCT02101021/results?page=2