MedTrace Logo

Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients

NCT02376296 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2022-02-17

No results posted yet for this 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.

Conditions

Interventions

DRUG

docetaxel

3-weekly docetaxel therapy (starting dose of 75 mg/m2)

OTHER

Blood draws

Blood draws for determination of docetaxel plasma levels and exposure (AUC)

Sponsors & Collaborators

  • UPMC CancerCenter

    collaborator UNKNOWN

  • Saladax Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Rahul A Parikh, MD, PhD · UPMC CancerCenter

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-02-10
Completion
2018-02-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02376296 on ClinicalTrials.gov