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Toxicity & Pharmacokinetics of 2 & 3-weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

NCT03343977 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-07-17

No results posted yet for this study

Summary

This study is designed to investigate the toxicity and pharmacokinetics (PK) of 2-weekly and 3-weekly docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC). Also, a mechanism-based population pharmacokinetics/pharmacodynamics (PK/PD) model will be developed to provide a better understanding of the complex relationships between the drug exposure and toxicity profiles of docetaxel in mHSPC.

Conditions

Interventions

DRUG

docetaxel 50mg/m2

50 mg/m2 of docetaxel will be given on day 1 every 14 days

DRUG

docetaxel 75mg/m2

75 mg/m2 of docetaxel will be given on day 1 every 21 days

Sponsors & Collaborators

  • Peng Wang, MD PhD

    lead OTHER

Principal Investigators

  • Peng Wang, MD, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-14
Primary Completion
2019-04-30
Completion
2029-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03343977 on ClinicalTrials.gov