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COMPLETED 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

NCT01529684 · View on ClinicalTrials.gov ↗

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

172 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01529684

The ClinicalTrials.gov registry entry for NCT01529684 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01529684 reports 2 study locations spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01529684?

The interventions under investigation include: OSI-906 (DRUG), radio-labeled OSI-906 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01529684?

This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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