Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Stomach Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

In the First Period, Only three Participants in the first dose group were randomly assigned to 175 mg/m2 paclitaxel micelle for injection at a 1:1 rate.175 mg/m2, 260 mg/m2, 320 mg/m2, and 390 mg/m2 of paclitaxel micelle for Injection was intravenously administrated for three hours,three weeks constituted one course of treatment.

three Participants were randomly assigned to 175 mg/m2 paclitaxel Injection,175 mg/m2 of conventional Paclitaxel Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.

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

Paclitaxel Micelles for Injection

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

Paclitaxel injection

jian liu, master

xiaochen zhang, docter

Jian Liu, Master

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.

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.

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.

MTD was determined as the dose where more than 2 out of 6 subjects experienced DLT

Determined as the recommended dose for a phase 2 study based on the adverse events and toxicities at each dose groups

Defined as maximum observed plasma concentration

Defined as time to maximum plasma concentration

Defined as area under plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration

Defined as area under plasma concentration-time curve from Hour 0 to infinity

Defined as the apparent plasma terminal phase disposition half-life

Defined as apparent volume of distribution

PR+CR,Imaging evaluations were performed with CT/MRI chest, abdominal, and pelvic scans

PR+CR+SD,Imaging evaluations were performed with CT/MRI chest, abdominal, and pelvic scans

Imaging evaluations were performed with CT/MRI chest, abdominal, and pelvic scans

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumors.	NCT04778839	Advanced Solid ...	Paclitaxel Mice... Paclitaxel inje...	18 Years - 70 Years	First Affiliated Hospital of Zhejiang University
Study of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumors.	NCT04778839	Advanced Solid ...	Paclitaxel Mice... Paclitaxel inje...	18 Years - 70 Years	First Affiliated Hospital of Zhejiang University
Study of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumors.	NCT04778839	Advanced Solid ...	Paclitaxel Mice... Paclitaxel inje...	18 Years - 70 Years	First Affiliated Hospital of Zhejiang University

Spots Global Cancer Trial Database for paclitaxel micelles