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NCT01114230 · ClinicalTrials.gov registry record · Phase 1

A First in Man Study to Determine the Safety at Various Dose Levels of AGS-16M8F in Advanced Kidney Cancer

A Phase 1 study of Renal Cell Carcinoma and Pharmacokinetics of AGS-16M8F, sponsored by Astellas Pharma.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target
3
Study locations

NCT01114230 is a Phase 1 study of Renal Cell Carcinoma and Pharmacokinetics of AGS-16M8F that has completed, run by Astellas Pharma. The registered enrollment target is 26 participants, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (89% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT01114230, a Phase 1 study of Renal Cell Carcinoma and Pharmacokinetics of AGS-16M8F, has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target
3
Study locations

Study Summary

The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK) of AGS-16M8F administered in subjects with advanced renal cell carcinoma.

Interventions

  • DRUG AGS-16M8F

Study Locations (3)

Massachusetts

  • Dana-Farber Cancer Institute - Boston

New York

  • Memorial Sloan Kettering Cancer Center - New York

Washington

  • Seattle Cancer Care Alliance - Seattle

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2010-08
Est. Completion 2012-11
Phase Phase 1

Sponsor

Astellas Pharma

165 total trials

What the Registry Record Tells You About NCT01114230

The ClinicalTrials.gov registry entry for NCT01114230 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (89% lower). The listed sponsor is Astellas Pharma, which has 165 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which AGS-16M8F is the first listed.

NCT01114230 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Massachusetts, New York, Washington.

Frequently Asked Questions

What is clinical trial NCT01114230 about?

NCT01114230 is a clinical study titled "A First in Man Study to Determine the Safety at Various Dose Levels of AGS-16M8F in Advanced Kidney Cancer". The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK) of AGS-16M8F administered in subjects with advanced renal cell carcinoma.

What is the current status of trial NCT01114230?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2010-08. Estimated completion is 2012-11.

What conditions does trial NCT01114230 study?

This clinical trial studies the following conditions: Renal Cell Carcinoma, Pharmacokinetics of AGS-16M8F.

What interventions are being tested in trial NCT01114230?

The interventions under investigation include: AGS-16M8F (DRUG).

Who is sponsoring clinical trial NCT01114230?

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

Where is trial NCT01114230 being conducted?

This trial has 3 study locations across Massachusetts, New York, Washington. 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

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