NCT04811118

The Comparison of the Pharmacokinetics of Albumin-bound Docetaxel and Taxotere

A Randomized, Open-label, Two-period, Crossover Trial to Compare the Pharmacokinetic Profiles Between Albumin-bound Docetaxel and Taxotere in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, two-period, crossover trial to evaluate the pharmacokinetic profiles of albumin-bound docetaxel for intravenous infusion and Taxotere in patients with advanced solid tumors.

Detailed description

The trial will be performed as a randomized, open-label, two-period crossover trial to compare the test drug (T, albumin-bound docetaxel) to the reference drug (R, Taxotere). Approximately 28 subjects will be randomized to the two treatment sequences (T-R or R-T) at the ratio of 1:1. Each enrolled subject will receive an intravenous infusion of the reference drug and the test drug in two treatment periods per the randomization schedule. The treatment periods will be separated by a washout period of 21 to 35 days. After completing two cycles of treatments, subjects may continue to receive the treatment used in the second cycle according to the responses (up to 1 year).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Docetaxel for Injection (Albumin-bound)	Docetaxel for Injection (Albumin-bound) by intravenous infusion
DRUG	Taxotere	Taxotere

Timeline

• Start date: 2021-05-18
• Primary completion: 2022-10-31
• Completion: 2022-12-31
• First posted: 2021-03-23
• Last updated: 2022-01-31

Locations

1 site across 1 country: China