Trial · NCT02119676
Study of Ruxolitinib in Colorectal Cancer Patients
NCT02119676, Phase 2, Terminated, Incyte Corporation; results first posted 2017-06-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Ruxolitinib in Colorectal Cancer Patients. Trials, record NCT02119676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02119676
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ruxolitinib in Colorectal Cancer Patients
- NCT number
- NCT02119676
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 396 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- CRC (Colorectal Cancer)
- Interventions
- Ruxolitinib, Regorafenib, Placebo
- First posted
- 2014-04-22
- Last updated
- 2018-02-13
- Results first posted
- 2017-06-14
- Limitations and caveats
- Substudy 1 was terminated for futility at interim analysis and Substudy 2 was terminated per sponsor decision.
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) | Baseline until death due to any cause; up to 16 months or data cut-off 11 FEB 2016. | Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis will be censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test. |
| Secondary | Progression Free Survival (PFS) | Baseline through disease progression, or death due to any cause if sooner; up to 16 months or data cut-off 11 FEB 2016. | 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 Longest Diameter (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 | Overall Response Rate (ORR) | Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016. | Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions without new lesion; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions, non-target lesion not progressed, and no new lesion; Progressive Disease=20% increase in sum of longest diameter of target lesions, or non-target lesion progression, or identification of new lesion; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants randomized. |
| Secondary | Duration of Response | Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016. | Duration of response is defined as the time from response (CR/PR) 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. |
| Secondary | Percentage of Participants Achieving Disease Control | Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016. | Disease control as measured by the percentage of participants whose best response was complete response (CR), partial response (PR), or stable disease (SD) per RECIST v.1.1. |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline through approximately 30 days post treatment discontinuation;up to 16 months or data cut-off 27JAN 2016 for Substudy 1 and up to the data cut-off of 11FEB2016 for Substudy 2. | TEAEs were defined as any adverse event (AE) during the study that began or worsened on or after the date of first dose of investigational product. |
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) | Baseline until death due to any cause; up to 16 months or data cut-off 11 FEB 2016. | Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Baseline through disease progression, or death due to any cause if sooner; up to 16 months or data cut-off 11 FEB 2016. | Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016. | Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study. | percentage of responders | NUMBER |
| SECONDARY | Duration of Response | Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016. | No data displayed because outcome measure has not been analyzed. Duration of response analyses was not done since there were no responders in Substudy 1 and very few responders in Substudy 2 at data cutoff (27JAN2016 for Substudy 1 and 11Feb2016 for Substudy 2). Duration of response analysis was not done in both substudies. | ||
| SECONDARY | Percentage of Participants Achieving Disease Control | Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016. | Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline through approximately 30 days post treatment discontinuation;up to 16 months or data cut-off 27JAN 2016 for Substudy 1 and up to the data cut-off of 11FEB2016 for Substudy 2. | Safety Population consists of all enrolled participants that received at least one dose of study drug. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Substudy 1: Ruxolitinib + Regorafenib | 4.6 | 95% Confidence Interval 3.5 to 5.4 | months | |
| Overall Survival (OS) | Substudy 1: Placebo + Regorafenib | 5.3 | 95% Confidence Interval 4.3 to 6.0 | months | |
| Overall Survival (OS) | Substudy 2: Ruxolitinib + Regorafenib | 11.4 | 95% Confidence Interval 9.0 to 13.2 | months | |
| Overall Survival (OS) | Substudy 2: Placebo + Regorafenib | 10.9 | 95% Confidence Interval 7.2 to NA | months | |
| Progression Free Survival (PFS) | Substudy 1: Ruxolitinib + Regorafenib | 2.2 | 95% Confidence Interval 1.9 to 3.0 | months | |
| Progression Free Survival (PFS) | Substudy 1: Placebo + Regorafenib | 2.1 | 95% Confidence Interval 1.8 to 2.7 | months | |
| Progression Free Survival (PFS) | Substudy 2: Ruxolitinib + Regorafenib | 3.5 | 95% Confidence Interval 3.0 to 3.8 | months | |
| Progression Free Survival (PFS) | Substudy 2: Placebo + Regorafenib | 2.0 | 95% Confidence Interval 1.9 to 3.1 | months | |
| Overall Response Rate (ORR) | Substudy 1: Ruxolitinib + Regorafenib | 0.0 | 95% Confidence Interval 0.0 to 4.2 | percentage of responders | |
| Overall Response Rate (ORR) | Substudy 1: Placebo + Regorafenib | 0.0 | 95% Confidence Interval 0.0 to 4.1 | percentage of responders |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Substudy 1: Ruxolitinib + Regorafenib | 87 | |
| Overall Study | STARTED | Substudy 1: Placebo + Regorafenib | 88 | |
| Overall Study | STARTED | Substudy 2: Ruxolitinib + Regorafenib | 110 | |
| Overall Study | STARTED | Substudy 2: Placebo + Regorafenib | 111 | |
| Overall Study | Treated Patients | Substudy 1: Ruxolitinib + Regorafenib | 85 | |
| Overall Study | Treated Patients | Substudy 1: Placebo + Regorafenib | 86 | |
| Overall Study | Treated Patients | Substudy 2: Ruxolitinib + Regorafenib | 106 | |
| Overall Study | Treated Patients | Substudy 2: Placebo + Regorafenib | 106 | |
| Overall Study | COMPLETED | Substudy 1: Ruxolitinib + Regorafenib | 4 | |
| Overall Study | COMPLETED | Substudy 1: Placebo + Regorafenib | 2 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events808
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 | Substudy 1: Ruxolitinib + Regorafenib | 10 | 85 | |
| other | Anaemia | Blood and lymphatic system disorders | Substudy 1: Placebo + Regorafenib | 12 | 86 | |
| other | Anaemia | Blood and lymphatic system disorders | Substudy 2: Ruxolitinib + Regorafenib | 27 | 106 | |
| other | Anaemia | Blood and lymphatic system disorders | Substudy 2: Placebo + Regorafenib | 12 | 106 | |
| other | Hypothyroidism | Endocrine disorders | Substudy 1: Ruxolitinib + Regorafenib | 2 | 85 | |
| other | Hypothyroidism | Endocrine disorders | Substudy 1: Placebo + Regorafenib | 6 | 86 | |
| other | Hypothyroidism | Endocrine disorders | Substudy 2: Ruxolitinib + Regorafenib | 4 | 106 | |
| other | Hypothyroidism | Endocrine disorders | Substudy 2: Placebo + Regorafenib | 3 | 106 | |
| other | Abdominal pain | Gastrointestinal disorders | Substudy 1: Ruxolitinib + Regorafenib | 21 | 85 | |
| other | Abdominal pain | Gastrointestinal disorders | Substudy 1: Placebo + Regorafenib | 24 | 86 |
1 to 10 of 808Source ClinicalTrials.gov
See all 808 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Substudy 1: Ruxolitinib + Regorafenib | ||
| Total, all-cause mortality | Substudy 1: Placebo + Regorafenib | ||
| Total, all-cause mortality | Substudy 2: Ruxolitinib + Regorafenib | ||
| Total, all-cause mortality | Substudy 2: Placebo + Regorafenib | ||
| Total, other adverse events | Substudy 1: Ruxolitinib + Regorafenib | 85 | 85 |
| Total, other adverse events | Substudy 1: Placebo + Regorafenib | 86 | 86 |
| Total, other adverse events | Substudy 2: Ruxolitinib + Regorafenib | 106 | 106 |
| Total, other adverse events | Substudy 2: Placebo + Regorafenib | 105 | 106 |
| Total, serious adverse events | Substudy 1: Ruxolitinib + Regorafenib | 49 | 85 |
| Total, serious adverse events | Substudy 1: Placebo + Regorafenib | 42 | 86 |
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/NCT02119676
GET https://conductscience.org/api/trials/v1/NCT02119676/results?page=2