ASG 5ME - Seattle Genetics
A phase 1 dose escalation trial of ASG-5ME in pancreatic adenocarcinoma (clinicaltrials.gov) - Jan 4, 2012 - P1, N=35; Recruiting -> Active, not recruiting; N=72-> 35 
Enrollment • Enrollment closed • Pancreatic Cancer
http://clinicaltrials.gov/ct2/show/NCT01166490
 
Jan 4, 2012
 
This study is ongoing, but not recruiting participants. First Received on July 19, 2010.   Last Updated on January 4, 2012   History of Changes Sponsor: Seattle Genetics, Inc. Collaborator: Astellas Pharma Inc Information provided by (Responsible Party): Seattle Genetics, Inc. ClinicalTrials.gov Identifier: NCT01166490   Purpose This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety and tolerability of ASG-5ME and to identify the maximum tolerated dose in patients with pathologically confirmed metastatic pancreatic adenocarcinoma. Condition Pancreatic Neoplasms Intervention Drug: ASG-5ME Phase Phase I Study Type: Interventional Study Design: Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: A Phase 1, Open-Label, Dose Escalation Study of ASG-5ME in Patients With Pancreatic Adenocarcinoma Resource links provided by NLM: MedlinePlus related topics: Cancer Pancreatic Cancer U.S. FDA Resources  Further study details as provided by Seattle Genetics, Inc.: Primary Outcome Measures: Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: Yes ] Secondary Outcome Measures: Best clinical response [ Time Frame: Every 2 months ] [ Designated as safety issue: No ] Overall and progression-free survival [ Time Frame: Every month until death or study closure ] [ Designated as safety issue: No ] Concentrations of ASG-5ME and metabolites in blood [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: No ] Incidence of antitherapeutic antibodies in blood [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: Yes ] Enrollment: 35 Study Start Date: July 2010 Estimated Study Completion Date: June 2012 Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)