At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 52 enrolled
Drug / intervention
JX-594 +1 morebiological
Likely dose
Irinotecan 180 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2a Dose-escalation Study of JX 594 Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.
In Brief
A Phase 2 clinical trial evaluating JX-594 and Irinotecan for Colorectal Carcinoma and CRC. Completed, enrolled 52 participants across 11 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Carcinoma, CRC
CountriesCanada, France, United States
CollaboratorsTransgene
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartJan 2012
Primary CompletionJun 2015
Study CompletionOct 2015
TodayJul 2026
First PostedJul 15, 2011
Enrollment StartJan 1, 2012
Primary CompletionJun 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.0 years ago
Interventions
JX-594biological
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Irinotecandrug
180 mg/m2 IV every 2 weeks.