Trial · NCT02117479
Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)
NCT02117479, Phase 3, Terminated, Incyte Corporation; results first posted 2017-07-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1). Trials, record NCT02117479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02117479
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)
- NCT number
- NCT02117479
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 321 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Pancreatic Cancer
- Interventions
- Ruxolitinib, Placebo, Capecitabine
- First posted
- 2014-04-21
- Last updated
- 2019-03-26
- Results first posted
- 2017-07-11
- Limitations and caveats
- The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation at the recommendation of the Data Monitoring Committee.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Randomization until death due to any cause; up to the data cutoff 11FEB2016. | Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016. |
| Secondary | Progression-free Survival (PFS) | Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016. | Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions. |
| Secondary | Percentage of Participants Achieving Progression Free Survival (PFS) | Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016. | PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions. |
| Secondary | Objective Response Rate (ORR) | Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016. | Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR. |
| Secondary | Duration of Response | Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016. | Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death. |
| Secondary | Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016. | A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Randomization until death due to any cause; up to the data cutoff 11FEB2016. | The intent-to-treat (ITT) population consisted of all participants randomized to the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) | Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016. | The intent-to-treat (ITT) population consisted of all participants randomized to the study. | days | MEDIAN |
| SECONDARY | Percentage of Participants Achieving Progression Free Survival (PFS) | Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016. | The intent-to-treat (ITT) population consisted of all participants randomized to the study. | percentage of participants | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016. | The intent-to-treat (ITT) population consisted of all participants randomized to the study. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016. | The intent-to-treat (ITT) population consisted of all participants randomized to the study. | days | MEDIAN |
| SECONDARY | Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016. | The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Ruxolitinib Plus Capecitabine | Observed | 113 | Participants | |
| Overall Survival (OS) | Placebo Plus Capecitabine | Observed | 124 | Participants | |
| Overall Survival (OS) | Ruxolitinib Plus Capecitabine | Censored | 48 | Participants | |
| Overall Survival (OS) | Placebo Plus Capecitabine | Censored | 36 | Participants | |
| Progression-free Survival (PFS) | Ruxolitinib Plus Capecitabine | 43.0 | 95% Confidence Interval 41.0 to 46.0 | days | |
| Progression-free Survival (PFS) | Placebo Plus Capecitabine | 44.0 | 95% Confidence Interval 42.0 to 48.0 | days | |
| Percentage of Participants Achieving Progression Free Survival (PFS) | Ruxolitinib Plus Capecitabine | Survival rate at 3 months | 18.9 | 95% Confidence Interval 12.7 to 25.9 | percentage of participants |
| Percentage of Participants Achieving Progression Free Survival (PFS) | Placebo Plus Capecitabine | Survival rate at 3 months | 19.8 | 95% Confidence Interval 13.6 to 26.8 | percentage of participants |
| Percentage of Participants Achieving Progression Free Survival (PFS) | Ruxolitinib Plus Capecitabine | Survival rate at 6 months | 6.1 | 95% Confidence Interval 2.5 to 12.2 | percentage of participants |
| Percentage of Participants Achieving Progression Free Survival (PFS) | Placebo Plus Capecitabine | Survival rate at 6 months | 5.7 | 95% Confidence Interval 2.3 to 11.3 | percentage of participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ruxolitinib Plus Capecitabine | 161 | |
| Overall Study | STARTED | Placebo Plus Capecitabine | 160 | |
| Overall Study | COMPLETED | Ruxolitinib Plus Capecitabine | 5 | |
| Overall Study | COMPLETED | Placebo Plus Capecitabine | 4 | |
| Overall Study | NOT COMPLETED | Ruxolitinib Plus Capecitabine | 156 | |
| Overall Study | NOT COMPLETED | Placebo Plus Capecitabine | 156 |
Source ClinicalTrials.gov
Adverse events388
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 | Nausea | Gastrointestinal disorders | Ruxolitinib Plus Capecitabine | 45 | 153 | |
| other | Nausea | Gastrointestinal disorders | Placebo Plus Capecitabine | 49 | 154 | |
| other | Anemia | Blood and lymphatic system disorders | Ruxolitinib Plus Capecitabine | 45 | 153 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo Plus Capecitabine | 22 | 154 | |
| other | Fatigue | General disorders | Ruxolitinib Plus Capecitabine | 47 | 153 | |
| other | Fatigue | General disorders | Placebo Plus Capecitabine | 50 | 154 | |
| other | Diarrhea | Gastrointestinal disorders | Ruxolitinib Plus Capecitabine | 42 | 153 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo Plus Capecitabine | 36 | 154 | |
| other | Abdominal pain | Gastrointestinal disorders | Ruxolitinib Plus Capecitabine | 36 | 153 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Plus Capecitabine | 49 | 154 |
1 to 10 of 388Source ClinicalTrials.gov
See all 388 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ruxolitinib Plus Capecitabine | ||
| Total, all-cause mortality | Placebo Plus Capecitabine | ||
| Total, other adverse events | Ruxolitinib Plus Capecitabine | 147 | 153 |
| Total, other adverse events | Placebo Plus Capecitabine | 145 | 154 |
| Total, serious adverse events | Ruxolitinib Plus Capecitabine | 94 | 153 |
| Total, serious adverse events | Placebo Plus Capecitabine | 83 | 154 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29508247 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ruxolitinib Plus Capecitabine vs Placebo Plus Capecitabine: serious adverse events |
Source 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/NCT02117479
GET https://conductscience.org/api/trials/v1/NCT02117479/results?page=2