Spots Global Cancer Trial Database for The Comparison of the Pharmacokinetics of Albumin-bound Docetaxel and Taxotere

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Trial Identification

Brief Title: The Comparison of the Pharmacokinetics of Albumin-bound Docetaxel and Taxotere

Official Title: 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

Study ID: NCT04811118

Conditions

Advanced Solid Tumors

Interventions

Docetaxel for Injection (Albumin-bound)

Taxotere

Study Description

Brief 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).