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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: Completed Phase 1 study of Advanced Solid Tumors and Pharmacokinetics of 14C-OSI-906, sponsored by Astellas Pharma Global Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Outcome measure for Part A: Area under the time concentration curve extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable time point (AUClast), Maximum Plasma Concentration (Cmax), Time to maximum concentration (Tmax), Terminal half-life (t 1/2), Apparent Body Clearance after dosing (CL/F), and Apparent volume of distribution (Vz/F)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-03-19 |
| Est. Completion | 2013-02-20 |
| Phase | Phase 1 |
What the finished NCT01529684 record still lists
NCT01529684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01529684's enrollment target sits among peer trials
5 143rd of 144 higher than 2 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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