Trial · NCT02277093
Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer
NCT02277093, Phase 2, Terminated, Washington University School of Medicine; results first posted 2017-05-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer. Trials, record NCT02277093. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02277093
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer
- NCT number
- NCT02277093
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Colorectal Cancer
- Interventions
- Pacritinib
- First posted
- 2014-10-28
- Last updated
- 2017-05-01
- Results first posted
- 2017-05-01
- Limitations and caveats
- Please note that the study ended early due to the FDA issuing a clinical hold as pacritinib had increased side effects.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Through completion of follow-up (median follow-up was 6.61 months) | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression - at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. |
| Secondary | Toxicity Profile and Tolerability as Measured by Reportable Adverse Events | Up to 28 days following last day of study treatment | * The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. * Reportable adverse events will be tracked for 28 days following the last day of study treatment. For the purposes of this protocol, reportable adverse events are events that are greater than or equal to grade 2 and are considered possibly, probably, or definitely related to study treatment. |
| Secondary | Overall Response Rate (ORR) | Through completion of follow-up (median follow-up was 6.61 months) | * The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. * Using RECIST 1.1 * The follow-up time was calculated from the start of treatment until death or on the final collection date of data on 10/27/2016. |
| Secondary | Time to Progression (TTP) | Through completion of follow-up (median follow-up was 6.61 months) | |
| Secondary | Overall Survival (OS) | Through completion of follow-up (median follow-up was 6.61 months) | -The follow-up time for OS was calculated from the start of treatment until death or on the final collection date of data on 10/27/2016. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Through completion of follow-up (median follow-up was 6.61 months) | months | MEDIAN | |
| SECONDARY | Toxicity Profile and Tolerability as Measured by Reportable Adverse Events | Up to 28 days following last day of study treatment | adverse event | NUMBER | |
| SECONDARY | Overall Response Rate (ORR) | Through completion of follow-up (median follow-up was 6.61 months) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Progression (TTP) | Through completion of follow-up (median follow-up was 6.61 months) | Only patients who had their first measurement scans were evaluable for this outcome measure. | months | MEAN |
| SECONDARY | Overall Survival (OS) | Through completion of follow-up (median follow-up was 6.61 months) | months | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Pacritinib | 1.91 | Inter-Quartile Range 1.81 to 8.75 | months | |
| Toxicity Profile and Tolerability as Measured by Reportable Adverse Events | Pacritinib | Diarrhea | 1 | adverse event | |
| Toxicity Profile and Tolerability as Measured by Reportable Adverse Events | Pacritinib | Edema limbs | 1 | adverse event | |
| Toxicity Profile and Tolerability as Measured by Reportable Adverse Events | Pacritinib | Edema face | 1 | adverse event | |
| Toxicity Profile and Tolerability as Measured by Reportable Adverse Events | Pacritinib | Fatigue | 1 | adverse event | |
| Toxicity Profile and Tolerability as Measured by Reportable Adverse Events | Pacritinib | Localized edema | 1 | adverse event | |
| Toxicity Profile and Tolerability as Measured by Reportable Adverse Events | Pacritinib | Blood bilirubin increased | 1 | adverse event | |
| Toxicity Profile and Tolerability as Measured by Reportable Adverse Events | Pacritinib | Dyspnea | 1 | adverse event | |
| Toxicity Profile and Tolerability as Measured by Reportable Adverse Events | Pacritinib | Rash maculopapular | 1 | adverse event | |
| Overall Response Rate (ORR) | Pacritinib | Complete response | 0 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pacritinib | 11 | |
| Overall Study | COMPLETED | Pacritinib | 11 | |
| Overall Study | NOT COMPLETED | Pacritinib | 0 |
Source ClinicalTrials.gov
Adverse events42
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 | Pacritinib | 2 | 11 | |
| other | Abdominal distension | Gastrointestinal disorders | Pacritinib | 1 | 11 | |
| other | Constipation | Gastrointestinal disorders | Pacritinib | 3 | 11 | |
| other | Diarrhea | Gastrointestinal disorders | Pacritinib | 1 | 11 | |
| other | Dyspepsia | Gastrointestinal disorders | Pacritinib | 1 | 11 | |
| other | Flatulence | Gastrointestinal disorders | Pacritinib | 1 | 11 | |
| other | Mucositis oral | Gastrointestinal disorders | Pacritinib | 2 | 11 | |
| other | Nausea | Gastrointestinal disorders | Pacritinib | 5 | 11 | |
| other | Rectal pain | Gastrointestinal disorders | Pacritinib | 1 | 11 | |
| other | Stomach pain | Gastrointestinal disorders | Pacritinib | 1 | 11 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pacritinib | ||
| Total, other adverse events | Pacritinib | 10 | 11 |
| Total, serious adverse events | Pacritinib | 4 | 11 |
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/NCT02277093
GET https://conductscience.org/api/trials/v1/NCT02277093/events?page=2