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NCT01409135 · ClinicalTrials.gov registry record · Phase 1

A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4

A Phase 1 study of Neoplasms and Tumors, sponsored by Astellas Pharma.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target
9
Study locations

NCT01409135 is a Phase 1 study of Neoplasms and Tumors that has completed, run by Astellas Pharma. The registered enrollment target is 34 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower). The trial reports 9 study locations across 8 states.

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The verdict

NCT01409135, a Phase 1 study of Neoplasms and Tumors, has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target
9
Study locations

Study Summary

A study examining the safety of AGS-22M6E or ASG-22CE administered as monotherapy therapy in subjects with malignant solid tumors that express Nectin-4.

Interventions

  • DRUG AGS-22M6E
  • DRUG ASG-22CE

Study Locations (9)

New York

  • Roswell Park Cancer Institute - Buffalo
  • Memorial Sloan Kettering Cancer Center - New York

California

  • UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco

Colorado

  • University of Colorado, Denver-Aurora - Aurora

Georgia

  • Emory University - Atlanta

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Michigan

  • Karmanos Cancer institute - Detroit

North Carolina

  • University of North Carolina, Chapel Hill - Chapel Hill

Alberta

  • Cross Cancer Institute - Edmonton

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2011-07-11
Est. Completion 2015-04-27
Phase Phase 1

Sponsor

Astellas Pharma

165 total trials

What the Registry Record Tells You About NCT01409135

The ClinicalTrials.gov registry entry for NCT01409135 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower). The listed sponsor is Astellas Pharma, which has 165 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which AGS-22M6E is the first listed.

NCT01409135 reports 9 study locations spanning 8 distinct geographic areas - top geographies include New York, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT01409135 about?

NCT01409135 is a clinical study titled "A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4". A study examining the safety of AGS-22M6E or ASG-22CE administered as monotherapy therapy in subjects with malignant solid tumors that express Nectin-4.

What is the current status of trial NCT01409135?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2011-07-11. Estimated completion is 2015-04-27.

What conditions does trial NCT01409135 study?

This clinical trial studies the following conditions: Neoplasms, Tumors, Medical Oncology.

What interventions are being tested in trial NCT01409135?

The interventions under investigation include: AGS-22M6E (DRUG), ASG-22CE (DRUG).

Who is sponsoring clinical trial NCT01409135?

This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01409135 being conducted?

This trial has 9 study locations across California, Colorado, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.