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NCT01529684 · ClinicalTrials.gov registry record · Phase 1

A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body

A Phase 1 study of Advanced Solid Tumors and Pharmacokinetics of 14C-OSI-906, sponsored by Astellas Pharma Global Development.

Completed
Registry status
Phase 1
Development phase
5
Enrollment target
2
Study locations

NCT01529684 is a Phase 1 study of Advanced Solid Tumors and Pharmacokinetics of 14C-OSI-906 that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 5 participants, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT01529684, a Phase 1 study of Advanced Solid Tumors and Pharmacokinetics of 14C-OSI-906, has completed, sponsored by Astellas Pharma Global Development.

COMPLETED
Registry status
Phase 1
Development phase
5 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled OSI-906. Subjects with Advanced Solid Tumors may participate and then continue into the Optional Treatment Phase.

Interventions

  • DRUG OSI-906
  • DRUG radio-labeled OSI-906

Study Locations (2)

Washington

  • Northwest Medical Specialties, PLLC - Tacoma
  • Comprehensive Clinical Development NW, Inc. - Tacoma

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2012-03-19
Est. Completion 2013-02-20
Phase Phase 1

Sponsor

Astellas Pharma Global Development

168 total trials

What the Registry Record Tells You About NCT01529684

The ClinicalTrials.gov registry entry for NCT01529684 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (97% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which OSI-906 is the first listed.

NCT01529684 reports 2 study locations spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT01529684 about?

NCT01529684 is a clinical study titled "A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body". The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled OSI-906. Subjects with Advanced Solid Tumors may participate and then continue into the Optional Treatment Phase.

What is the current status of trial NCT01529684?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2012-03-19. Estimated completion is 2013-02-20.

What conditions does trial NCT01529684 study?

This clinical trial studies the following conditions: Advanced Solid Tumors, Pharmacokinetics of 14C-OSI-906.

What interventions are being tested in trial NCT01529684?

The interventions under investigation include: OSI-906 (DRUG), radio-labeled OSI-906 (DRUG).

Who is sponsoring clinical trial NCT01529684?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01529684 being conducted?

This trial has 2 study locations across 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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