RecruitingPhase 1NCT04778839

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.


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

98 participants

Start Date

Mar 4, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new formulation of paclitaxel (a standard chemotherapy drug) called "paclitaxel micelles" — tiny nanoparticles that may deliver the drug more effectively and with fewer side effects — in Chinese patients with advanced solid tumors that have not responded to standard treatments. **You may be eligible if...** - You are 18–70 years old with a confirmed advanced solid tumor - Standard cancer treatments are no longer working or available for you - Your life expectancy is at least 3 months - You are in reasonably good health (ECOG 0–2) - You have at least one measurable or evaluable tumor on imaging **You may NOT be eligible if...** - You have received chemotherapy, radiation, or other cancer treatments within the past 4 weeks - You have brain metastases (cancer that has spread to the brain) - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel Micelles for Injection

Paclitaxel Micelles for Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.

DRUGPaclitaxel injection

Paclitaxel Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.


Locations(1)

The First Affiliated Hospital,ZheJiang Univercity

Hanzhou, Zhejiang, China

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NCT04778839


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