NCT04471675

Evaluation of the Safety and Efficacy of Albumin-bound Docetaxel

Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Albumin-bound Formulation of Docetaxel for Intravenous Infusion in Patients With Advanced Solid Tumors: A Phase 1, Single-center, Open-label, Dose-escalation Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of albumin-bound formulation of docetaxel for intravenous infusion in patients with advanced solid tumors.

Detailed description

This study was conducted in two stages. The first stage (Stage I) is a dose-escalation study. A classic 3+3 design will be used to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Patients with advanced solid tumors will be assigned to receive sequentially higher doses of albumin-bound formulation of docetaxel once every three weeks (a Cycle) by intravenous infusion, starting at a dose of 50mg/m2. Patients will receive the albumin-bound formulation of docetaxel

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Albumin-bound docetaxel	Albumin-bound docetaxel by intravenous infusion.

Timeline

• Start date: 2020-12-02
• Primary completion: 2022-12-15
• Completion: 2023-12-15
• First posted: 2020-07-15
• Last updated: 2022-01-31

Locations

1 site across 1 country: China