A study of CP-4126 in patients with advanced pancreatic cancer (clinicaltrials.gov) - Feb 9, 2012 - P2, N=40 -> 21; Active, not recruiting -> Completed; Completion date: Mar 2011 -> Sep 2011
Trial completion • Pancreatic Cancer
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This study has been completed.
First Received on June 3, 2009. Last Updated on February 9, 2012 History of Changes
Sponsor: Clavis Pharma
Information provided by (Responsible Party): Clavis Pharma
ClinicalTrials.gov Identifier: NCT00913198
Purpose
The main objective of this study is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer. In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.
Condition
Advanced Adenocarcinoma of Pancreas
Intervention
Drug: IV CP-4126
Phase
Phase II
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of CP-4126 in Patients With Advanced Pancreatic Cancer.
Resource links provided by NLM:
MedlinePlus related topics: Cancer Pancreatic Cancer
U.S. FDA Resources
Further study details as provided by Clavis Pharma:
Primary Outcome Measures:
Biological activity of CP-4126 in patients with advanced pancreatic cancer. [ Time Frame: Every second cycle ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Overall survival, Objective response rate. [ Time Frame: Every second cycle - study length ] [ Designated as safety issue: No ]
Enrollment: 21
Study Start Date: April 2009
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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