Phase 2 Study to Assess the Efficacy & Safety of Gemcitabine + Nab Paclitaxel With or Without Dociparstat in Metastatic Pancreatic Cancer Patients

NCT01461915 ↗

Phase 2 Terminated 60 enrolled Jazz Pharmaceuticals Translational Drug Development · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized, Phase 2, open label study aims to assess the efficacy and safety of gemcitabine + nab paclitaxel with or without dociparstat (ODSH) as first line treatment of metastatic pancreatic cancer. This study consists of 2 periods: a Run-in Period and a Randomized Period.

Timeline

Start: 2011-11
Primary completion: 2012-12
Completion: 2015-06

Publications

Background Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. doi: 10.1200/JCO.2011.36.5742. Epub 2011 Oct 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dociparstat	Other / unclassified	0.375 mg/kg	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	125 mg/m2	Intravenous

Phase 2 Study to Assess the Efficacy & Safety of Gemcitabine + Nab Paclitaxel With or Without Dociparstat in Metastatic Pancreatic Cancer Patients

Summary

Timeline

Publications

Drugs

Indications