2006-02
2007-08
2007-08
26
NCT00338026
Thallion Pharmaceuticals
Thallion Pharmaceuticals
INTERVENTIONAL
A Phase I Study of ECO-4601 in Patients With Advanced Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2006-06-15 | N/A | 2008-07-10 |
2006-06-16 | N/A | 2008-07-15 |
2006-06-20 | N/A | 2008-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: ECO-4601 | DRUG: ECO-4601
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Safety/tolerability of ECO-4601 | ||
Determination of MTD of ECO-4601 | ||
Determination of recommended dose for future studies of ECO-4601 |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Pharmacokinetics of ECO-4601 | ||
Safety of multiple cycles of administration of ECO-4601 | ||
Documentation of ECO-4601 antitumor activity as per RECIST criteria |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
Copyright © 2024 – National Pancreatic Cancer Foundation | All Rights Reserved