Trial · NCT01394939
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
NCT01394939, Phase 1, Phase 2, Completed, Jennerex Biotherapeutics; results first posted 2021-01-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma. Trials, record NCT01394939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01394939
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
- NCT number
- NCT01394939
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Jennerex Biotherapeutics
- Conditions
- Colorectal Carcinoma, CRC
- Interventions
- JX-594, Irinotecan
- First posted
- 2011-07-15
- Last updated
- 2026-08-05
- Results first posted
- 2021-01-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study | Scans every 8 weeks until progression, assessed up to 25 months | Percentage of participants with overall response (CR+PR) during the study per mRECIST 1.1. CR: disappearance of enhancing area; PR: \>=30% decrease in sum of enhancing area diameters. Per mRECIST 1.1, an objective response at week 8 must be confirmed by a subsequent scan to be classified as an overall response during the study. If a participant achieved a response at week 8, but the response was not confirmed at the subsequent visit, then the participant may be included in the 'ORR at Week 8 (CR+PR)' Row, but may not be included in the 'ORR During the study (CR+PR)' Row. |
| Secondary | Progression Free Survival | CT scans every 8 weeks until progression, assessed up to 25 months | PFS (based on mRECIST) as determined by Independent Central Review is summarized for the ITT Population. |
| Secondary | Overall Survival | Monthly until Death or Lost-to-Followup, assessed up to 25 months | Compare overall survival time of patients treated with JX-594 alone or in combination with irinotecan |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study | Scans Every 8 weeks until radiographic progression was confirmed by the site. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study | Single Agent_ Cohort 1 | 0 | Participants | ||
| Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study | Single Agent_Cohort 2 | 0 | Participants | ||
| Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study | Combination_Cohort 3 | 0 | Participants | ||
| Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study | Combination_Cohort 4 | 1 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Agent_ Cohort 1 | 4 | |
| Overall Study | STARTED | Single Agent_Cohort 2 | 25 | |
| Overall Study | STARTED | Combination_Cohort 3 | 4 | |
| Overall Study | STARTED | Combination_Cohort 4 | 17 | |
| Overall Study | COMPLETED | Single Agent_ Cohort 1 | 3 | |
| Overall Study | COMPLETED | Single Agent_Cohort 2 | 15 | |
| Overall Study | COMPLETED | Combination_Cohort 3 | 4 | |
| Overall Study | COMPLETED | Combination_Cohort 4 | 10 | |
| Overall Study | NOT COMPLETED | Single Agent_ Cohort 1 | 1 | |
| Overall Study | NOT COMPLETED | Single Agent_Cohort 2 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events820
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 | Single Agent_ Cohort 1 | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Single Agent_Cohort 2 | 6 | 25 | |
| other | Anaemia | Blood and lymphatic system disorders | Combination_Cohort 3 | 2 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Combination_Cohort 4 | 6 | 17 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Single Agent_ Cohort 1 | 0 | 4 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Single Agent_Cohort 2 | 0 | 25 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Combination_Cohort 3 | 2 | 4 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Combination_Cohort 4 | 1 | 17 | |
| other | Leukopenia | Blood and lymphatic system disorders | Single Agent_ Cohort 1 | 0 | 4 | |
| other | Leukopenia | Blood and lymphatic system disorders | Single Agent_Cohort 2 | 0 | 25 |
1 to 10 of 820Source ClinicalTrials.gov
See all 820 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Agent_ Cohort 1 | 0 | 4 |
| Total, all-cause mortality | Single Agent_Cohort 2 | 2 | 25 |
| Total, all-cause mortality | Combination_Cohort 3 | 0 | 4 |
| Total, all-cause mortality | Combination_Cohort 4 | 0 | 17 |
| Total, other adverse events | Single Agent_ Cohort 1 | 4 | 4 |
| Total, other adverse events | Single Agent_Cohort 2 | 25 | 25 |
| Total, other adverse events | Combination_Cohort 3 | 4 | 4 |
| Total, other adverse events | Combination_Cohort 4 | 17 | 17 |
| Total, serious adverse events | Single Agent_ Cohort 1 | 2 | 4 |
| Total, serious adverse events | Single Agent_Cohort 2 | 10 | 25 |
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/NCT01394939
GET https://conductscience.org/api/trials/v1/NCT01394939/events?page=2