Efficacy and Safety of BC-819 and Gemcitabine in Patients With Locally Advanced Pancreatic Adenocarcinoma
Summary
This is a multicenter, open label, randomized, phase 2b study, designed to evaluate the safety and efficacy of patients with locally advanced pancreatic adenocarcinoma following intratumoral administration of BC-819 and intravenously administered gemcitabine. Intratumoral injections of BC-819 will be performed using endoscopic ultrasound (EUS). Primary Objective: To assess the effect of intratumoral endoscopic ultrasound injection of BC-819 administered with intravenous gemcitabine on progression-free survival. Secondary Objectives: To compare the effects of intratumoral injection of BC-819 administered in combination with intravenous gemcitabine vs. intravenous gemcitabine alone on: Overall survival, Response rate, Resectability of the target tumor lesion, Quality of life, Safety, Serological Tumor Marker: CA 19-9, Duration of response, Failure-free survival
Timeline
- Start
- 2011-09
- Primary completion
- 2013-01
- Completion
- 2014-05
Outcome
Missed primary endpoint
Stopped: “Due to Sponsor's decision, only 12 patients were randomized \& completed study.”
registry analysis (superiority test); 8 mg BC-819 and Gemcitabine vs 12 mg BC-819 and Gemcitabine; p = 0.483; Log Rank NCT01413087 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | inodiftagene vixteplasmid | Other / unclassified | 8 mg | Other |
| Subject | inodiftagene vixteplasmid | Other / unclassified | 12 mg | Other |