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NCT02376296 · ClinicalTrials.gov registry record
Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients
A clinical trial of Prostate Cancer, sponsored by Saladax Biomedical.
- Completed
- Registry status
- 35
- Enrollment target
- 20
- Study locations
NCT02376296: Completed study of Prostate Cancer, sponsored by Saladax Biomedical.
NCT02376296 is a study of Prostate Cancer that has completed, run by Saladax Biomedical. The registered enrollment target is 35 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02376296, a study of Prostate Cancer, has completed, sponsored by Saladax Biomedical.
- COMPLETED
- Registry status
- 35 participants
- Enrollment target
- 20
- Study locations
Study Summary
In this observational study, blood samples for pharmacokinetic (PK) testing will be collected from subjects with metastatic prostate cancer during their treatment with docetaxel. Plasma levels of docetaxel will be determined, and the subjects docetaxel exposure levels, determined as an area under the curve (AUC), will be retrospectively correlated with reports of toxicity, tumor response, quality of life, time to disease progression and overall survival to provide guidance on what the appropriate target range for docetaxel exposure should be for metastatic prostate cancer subjects receiving docetaxel therapy for their disease.
Primary Outcome
Blood will be drawn during the first six cycles of docetaxel therapy to determine the variability of docetaxel exposure.
Conditions Studied
Interventions
- OTHER Blood draws
- DRUG docetaxel
Study Locations (20)
Pennsylvania
- UPMC CancerCenter - Beaver - Beaver
- UPMC CancerCenter - Upper St. Clair - Bethel Park
- UPMC CancerCenter - Horizon - Farrell
- Arnold Palmer Cancer Center - Oakbrook - Greensburg
- Arnold Palmer Cancer Center - Greensburg
- UPMC CancerCenter - Greenville - Greenville
- UPMC CancerCenter - Indiana - Indiana
- UPMC CancerCenter at John P. Murtha Regional Cancer Center - Johnstown
- UPMC CancerCenter - Mckeesport - McKeesport
- UPMC CancerCenter - Monroeville - Monroeville
- Arnold Palmer Medical Oncology - Mount Pleasant - Mount Pleasant
- UPMC CancerCenter - New Castle - New Castle
- UPMC CancerCenter - St. Margaret - Pittsburgh
- UPMC CancerCenter - Hillman Cancer Center - Pittsburgh
- UPMC CancerCenter - Passavant HOA - Pittsburgh
- UPMC CancerCenter - Passavant OHA - Pittsburgh
- UPMC CancerCenter - Northwest - Seneca
- UPMC CancerCenter - Uniontown - Uniontown
- UPMC CancerCenter - Washington - Washington
- UPMC CancerCenter - Jefferson - West Mifflin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2015-02 |
| Est. Completion | 2018-02-10 |
What the finished NCT02376296 record still lists
NCT02376296 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Blood draws is the first listed.
NCT02376296 names 20 study sites across 1 states, led by Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02376296 about?
NCT02376296 is a clinical study titled "Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients". In this observational study, blood samples for pharmacokinetic (PK) testing will be collected from subjects with metastatic prostate cancer during their treatment with docetaxel. Plasma levels of docetaxel will be determined, and the subjects docetaxel exposure levels, determined as an area under th...
What is the current status of trial NCT02376296?
This trial is currently completed. The enrollment target is 35 participants. The study started on 2015-02. Estimated completion is 2018-02-10.
What conditions does trial NCT02376296 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT02376296?
The interventions under investigation include: Blood draws (OTHER), docetaxel (DRUG).
Who is sponsoring clinical trial NCT02376296?
This trial is sponsored by Saladax Biomedical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02376296 being conducted?
This trial has 20 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
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 NCT02376296's enrollment target sits among peer trials
35 552nd of 735 higher than 180 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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.
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