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NCT01394939 · ClinicalTrials.gov registry record · Phase 1
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
A Phase 1 study of Colorectal Carcinoma and CRC, sponsored by Jennerex Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 11
- Study locations
NCT01394939: Completed Phase 1 study of Colorectal Carcinoma and CRC, sponsored by Jennerex Biotherapeutics.
NCT01394939 is a Phase 1 study of Colorectal Carcinoma and CRC that has completed, run by Jennerex Biotherapeutics. The registered enrollment target is 52 participants, below the 1,095-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (95% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01394939, a Phase 1 study of Colorectal Carcinoma and CRC, has completed, sponsored by Jennerex Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.
Primary Outcome
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 (C
Conditions Studied
Interventions
- DRUG Irinotecan
- BIOLOGICAL JX-594
Study Locations (11)
Other
- Hôpital Saint Antoine - Paris
- Hôpital Hautepierre - Strasbourg
- Institut Claudius Regaud - Toulouse
Ohio
- Gabrail Cancer Center - Canton
- The Ohio State University - Columbus
Ontario
- Juravinski Cancer Centre - Hamilton
- Ottawa Hospital and Research Institute (OHRI) - Ottawa
Arizona
- Mayo Clinic - Scottsdale
California
- UCSD Moores Cancer Center - La Jolla
Montana
- Billings Clinic Cancer Center - Billings
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-10 |
| Phase | Phase 1 |
What the finished NCT01394939 record still lists
NCT01394939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 1,095-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Colorectal Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Irinotecan is the first listed.
NCT01394939 lists 11 locations in 7 states (Other, Ohio, Ontario).
Frequently Asked Questions
What is clinical trial NCT01394939 about?
NCT01394939 is a clinical study titled "Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma". The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.
What is the current status of trial NCT01394939?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2012-01. Estimated completion is 2015-10.
What conditions does trial NCT01394939 study?
This clinical trial studies the following conditions: Colorectal Carcinoma, CRC.
What interventions are being tested in trial NCT01394939?
The interventions under investigation include: Irinotecan (DRUG), JX-594 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01394939?
This trial is sponsored by Jennerex Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01394939 being conducted?
This trial has 11 study locations across Arizona, California, Montana, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01394939's enrollment target sits among peer trials
52 39th of 53 higher than 15 of 53 other Colorectal Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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