NCT01963052 (Clinical Trial/ AGS15E/ AGS-15ME)

Study Title

ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer (NCT01963052)

Trial Description

All subjects will receive a single intravenous infusion of AGS15E once weekly for 3 weeks of every 4 weeks. A cycle is 4 weeks. Subjects will continue treatment until disease progression, intolerability of AGS15E, investigator decision, or consent withdrawal.

The study design will follow a modified Continual Reassessment Method (CRM). A disease assessment will be conducted every 8 weeks (Q8W) +/- 7 days until disease progression.

A data review team (DRT) will review cumulative unaudited data on an interim basis to explore additional doses and/or schedules, or the expansion of existing cohorts. Doses intermediate to those predefined in the protocol may be explored with DRT endorsement.All subjects will receive a single intravenous infusion of AGS15E once weekly for 3 weeks of every 4 weeks. A cycle is 4 weeks.

Subjects will continue treatment until disease progression, intolerability of AGS15E, investigator decision, or consent withdrawal.The study design will follow a modified Continual Reassessment Method (CRM). A disease assessment will be conducted every 8 weeks (Q8W) +/- 7 days until disease progression.
A data review team (DRT) will review cumulative unaudited data on an interim basis to explore additional doses and/or schedules, or the expansion of existing cohorts. Doses intermediate to those predefined in the protocol may be explored with DRT endorsement.

This trial is sponsored by Astellas Pharma Inc® in collaboration with Seattle Genetics®.

Study Data

  • Condition: Metastatic Urothelial Cancer
  • Interventions:
    • Drugs used in this trial
      • AGS-15E
  • Phase: I
  • Enrollment: 93
  • Start: November 2013
  • Estimated Completion: November 2017
  • Last verified: June 2017
  • Last Updated: June 2017

Study Schematic

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Last Editorial review: August 23, 2017
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.