NCT03343977

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

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• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Peng Wang, MD PhD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 \<0.2 ng/mL at 12 months, and progression-free survival at 12 months are selected as the secondary clinical endpoints of the study.

Conditions

• Metastatic Hormone-Sensitive Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-02-14
• Primary completion: 2019-04-30
• Completion: 2029-04-30
• First posted: 2017-11-17
• Last updated: 2018-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study