Pancreatic Cancer Research

Clinical trialPhase 1Completed

A Phase I Study of ECO-4601 in Patients With Advanced Cancer

A Phase I, Dose Finding, Pharmacokinetic, and Safety Study of Continuous IV Infusion of ECO-4601 in Patients With Advanced Cancer Including an Extension Portion to Obtain Safety Data at the Highest Tolerable Dose

Outcome
Finished, no results posted
Phase
Phase 1
Status
Completed
Study type
Interventional
Start
February 2006
Expected end
August 2007
Enrollment
26 participants
Sites
2
Primary outcomes
Safety/tolerability of ECO-4601; Determination of MTD of ECO-4601; Determination of recommended dose for future studies of ECO-4601
Sponsor
Industry
Results posted
No
Last update
15 July 2008

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Brief summary public domain (ClinicalTrials.gov)

The purpose of this study was to determine the maximum tolerated dose (MTD) and the recommended dose for future studies of ECO-4601 administered as a continuous IV infusion for 14 days with 7 days recovery (21 day cycle) in patients with histologically confirmed solid tumors (high grade glioma, colorectal, lung, breast, ovarian, pancreatic and prostate). This study was also designed to determine the clinical pharmacokinetic profile, safety of multiple cycles of administration, and document the antitumor activity of ECO-4601.