Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

In the First Period, 230 mg/m2 of Paclitaxel Micelles for Injection was intravenously administrated for three hours without special infusion device, then 70 mg/m2 of Cisplatin was intravenously administrated for two hours. Three weeks constituted one course of treatment.

In the Second Period, 300 mg/㎡ of Paclitaxel Micelles for Injection was intravenously administrated for three hours without special infusion device to patients whose minimum neutrophil ≥1.0 × 109 /L and minimum platelet count ≥80 × 109 /L and with no hematologic toxicity of grade II to IV occurred in the First Period. Then 70 mg/m2 of Cisplatin was intravenously administrated for two hours. Three weeks constituted one course of treatment.

175 mg/m2 of conventional Paclitaxel Injection was intravenously administrated for three hours, then 70 mg/m2 of Cisplatin was intravenously administrated for two hours. Three weeks constituted one course of treatment.

Paclitaxel Micelles for Injection

Paclitaxel Injection

Baohui Han

Yilong Wu

Meiqi Shi

An open-label randomized and controlled clinical trial: This study was to compare the anticancer efficacy and safety in the First-Line Treatment in patients with Advanced Non-Small-Cell Lung Cancer with Paclitaxel Micelles for Injection In combination with Cisplatin versus Paclitaxel Injection Containing Cremophor EL(polyoxyethylenated castor oil) In combination with Cisplatin in the way of an open-label, randomized controlled clinical trial.

Treatment Protocol:

The subjects were randomized in the Paclitaxel Micelles for Injection Group and the Paclitaxel Injection Group by the proportion of 2:1. The centralized randomization method was adopted in this trial. Since the study was a comparison of first-line treatment, the test for superiority was adopted. The objective response rate was the primary indicator of efficacy in this study.

Trial Group:

Paclitaxel Micelles for Injection and Cisplatin was intravenously administrated. Three weeks constituted one course of treatment.

No pretreatment, including anti-allergic prevention and antiemetic prophylaxis, was required for the patients before infusion of Paclitaxel Micelles for Injection patients.

Control Group:

Conventional Paclitaxel Injection and Cisplatin was intravenously administrated. Three weeks constituted one course of treatment.

Standard preventive treatment must be given to patients in accordance with the specific requirements in specifications of Paclitaxel Injection.

Regardless of the Trial Group or the Control Group, six treatment periods shall be the upper limit.

To estimate the sample size based on objective remission indicators (CR + PR) in the study. Hypothesis: the objective remission rate of the Paclitaxel Micelles for Injection combined with Cisplatin in the Trial Group is different with that of first-line treatment of advanced non-small cell lung cancer, and is also different with that of the Cremophor EL-containing Paclitaxel Injection combined with Cisplatin in the Control Group. Trial parameter settings: assuming α = 0.05 and 1-β = 80%, the Trial Group: Control Group is designed as per the proportion of 2: 1. According to the sample size formula , a total of 426 patients is required, including 284 patients assigned in the Trial Group and 142 in the Control Group. In consideration of case expulsion in the process of clinical, enlarged by 10%, actually 468 cases were included in the groups, including 312 in the Trial Group and 156 in the Control Group.

Paclitaxel Micelles for Injection / Paclitaxel Injection in Combination With Cisplatin for First-line Therapy of Advanced NSCLC

Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

PFS(Progression-Free-Survival) was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first.

Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.

Shanghai Yizhong Pharmaceutical Co., Ltd.

Digestive System Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Stomach Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Stomach Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

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 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
Paclitaxel Micelles for Injection / Paclitaxel Injection in Combination With Cisplatin for First-line Therapy of Advanced NSCLC	NCT02667743	Non-Small Cell ...	Paclitaxel Mice... Paclitaxel Inje... Cisplatin	18 Years - 70 Years	Shanghai Yizhong Pharmaceutical Co., Ltd.
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 for injection