Ignite Creation Date:
2024-05-06 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03343977
Status:
WITHDRAWN
Last Update Posted:
2018-07-17
First Post:
2017-10-06
Brief Title:
Toxicity Pharmacokinetics of 2 3-weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer mHSPC
Sponsor:
Peng Wang MD PhD
Organization:
University of Kentucky
Study Overview
Official Title:
A Prospective Open-label Randomized Two-arm Pilot Study to Investigate the Toxicity and Pharmacokinetics of 2-Weekly and 3-Weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
Status:
WITHDRAWN
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study withdrawn for technical reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 pharmacokineticspharmacodynamics PKPD model will be developed to provide a better understanding of the complex relationships between the drug exposure and toxicity profiles of docetaxel in mHSPC
Detailed Description:
This pilot study is designed to investigate the toxicity and PK of 2-weekly and 3-weekly docetaxel in mHSPC Furthermore a mechanism-based population PK pharmacodynamics 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 In addition selected pro-inflammatory and macrophage-associated cytokines will be collected to assess the potential role of these cytokines as the early markers of docetaxel resistance in patients with mHSPC Cytokines macrophage inhibitory cytokine 1 MIC1 interleukin IL-1ra IL-1β IL-4 IL-6 IL-12 and IFNγ Serological response defined as a prostate-specific antigen PSA level of 02 ngmL at 12 months and progression-free survival at 12 months are selected as the secondary clinical endpoints of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None