NCT04778839

Study of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumors.

A Phase I Study of Dose Escalation and Dose Expansion To Evaluate the Safety、Tolerability、Pharmacokinetics and Efficacy of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumor.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Phase I Study of Dose Escalation and Dose Expansion To Evaluate the Safety、Tolerability、Pharmacokinetics and Preliminary Efficacy of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumor.

Detailed description

The study will be conducted in two parts. The first part is dose escalation and the second part is dose Expansion.During the course of dose escalation, 18-27 subjects will be enrolled to assess the safety、tolerability、pharmacokinetics、preliminary efficacy ,and determine the dose-limiting toxicity (DLT) and maximum tolerated dose(MTD) of Paclitaxel Micelles for Injection, and explore phase II clinical dosages. The second part will be adjusted according to the result of the first part. It will be divided into 4 groups, including advanced breast cancer group, ovarian cancer group, non-small cell lung cancer group and gastric cancer group, with 20 subjects in each group, to further evaluate the safety, tolerance, PK and anti-tumor activity of paclitaxel micelle.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Paclitaxel Micelles for Injection	Paclitaxel Micelles for Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.
DRUG	Paclitaxel injection	Paclitaxel Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.

Timeline

• Start date: 2021-03-04
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2021-03-03
• Last updated: 2025-08-06

Locations

1 site across 1 country: China