drugset / Trial / NCT00882973

Trial to Determine the Maximum Tolerated Dose of Genexol-PM Plus Gemcitabine and Evaluate Efficacy and Safety of Genexol-PM Regimens in Subjects With Advanced Pancreatic Cancer

NCT00882973 ↗

Phase 1 Completed 18 enrolled Samyang Biopharmaceuticals Corporation
Non-randomizedParallel-groupTreatment

Summary

This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced or metastatic pancreatic cancer.

Timeline

Start
2008-09
Primary completion
2009-08
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 220 mg/m2 —
Subject Paclitaxel Small molecule 260 mg/m2 —
Subject Paclitaxel Small molecule 300 mg/m2 —