drugset
drugset / Trial / NCT02340117

Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer

NCT02340117 ↗

Phase 2 Active not recruiting 28 enrolled SynerGene Therapeutics, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This clinical trial is an open label Phase II study of the combination of intravenously administered SGT-53 and gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer. The objective of the study is to evaluate the safety, tolerability, toxicity and efficacy (specifically Progression Free Survival at 5.5 month (PFS5.5mos)) of this combination therapy.

Timeline

Start
2015-01
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject SGT-53 Other / unclassified 0.6 mg Intravenous
Subject SGT-53 Other / unclassified 1.2 mg Intravenous
Subject SGT-53 Other / unclassified 2.4 mg Intravenous
Subject SGT-53 Other / unclassified 3.6 mg Intravenous
Background Gemcitabine Small molecule 600 mg/m2 Intravenous
Background Gemcitabine Small molecule 800 mg/m2 Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Paclitaxel Small molecule 75 mg/m2 Intravenous
Background Paclitaxel Small molecule 100 mg/m2 Intravenous
Background Paclitaxel Small molecule 125 mg/m2 Intravenous

Indications

malignant pancreatic neoplasm