A Study of Docetaxel Polymeric Micelles for Injection in Patients With Advanced Solid Tumors

An Open, Multi-cohort, Phase II Clinical Study Evaluating the Efficacy and Safety of Docetaxel Polymer Micelles for Injection in Patients With Advanced Malignant Solid Tumors

This study is an open, multi-cohort phase II clinical trial, the overall design is divided into two parts: dose confirmation stage and expansion stage. Dose confirmation stage is to evaluate the safety and tolerability of three dosing regimenes of docetaxel polymer micelle for injection in patients with advanced esophageal cancer, and to determine the best dosing regimenes for entering the expansion stage. The expansion stage iwas used to evaluate the efficacy and further safety of the best dosing regimen identified in the dose confirmation stage in patients with advanced solid tumors. All subjects in the dose confirmation stage and expansion stage will continue treatment according to the injection docetaxel micelle regimen they received at enrollment until the disease progresses or the investigator determines that continuing treatment with the study drug will not benefit, or any intolerable toxicity occurs, or they voluntarily withdraw, or for other reasons, whichever occurs first.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Docetaxel Polymeric Micelles for Injection

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hongmei Lin, Ph.D; Phone Number: +8615910575714; Email: linhongmei@simcere.com
• Study Contact Backup: Name: Zhi Zhang, Bachelor; Phone Number: +8618670738874; Email: zhangzhi4@simcere.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233099
      • The First Affiliated Hospital of Bengbu Medical College
      • Contact: Duojie Li, Master; Phone Number: +8613956332626; Email: liduojie@163.com
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • The Forth Hospital of Hebei Medical University
      • Contact: Jun Wang, Ph.D; Phone Number: +8613931182128; Email: wangjunzr@163.com
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The first affiliated hospital of Zhengzhou university
      • Contact: Yanru Qin, Ph.D; Phone Number: +8613676932999; Email: yanruqin@163.com
    • Zhengzhou, Henan, China, 450003
      • Henan Cancer Hospital
      • Contact: Suxia Luo, Ph.D; Phone Number: +8618638553211; Email: luosxrm@163.com
  • Hunan
    • Changsha, Hunan, China, 410031
      • Hunan Cancer Hospital
      • Contact: Hui Wang, Ph.D; Phone Number: +8613973135460; Email: Wanghui710327@163.com
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Cancer Hospital
      • Contact: Hui Luo, Master; Phone Number: +8613707917606; Email: luohui65001@163.com
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
      • Contact: Bo liu, Master; Phone Number: +8615553115688; Email: 15553115688@163.com
  • Shanghai
    • Shanghai, Shanghai, China, 200123
      • Shanghai East Hospital
      • Contact: Ye Guo, Ph.D; Phone Number: +8613501678472; Email: pattrickguo@gmail.com
      • Principal Investigator: Ye Guo, Ph.D
  • Tianjin
    • Tianjin, Tianjin, China, 300181
      • Tianjin Medical University Cancer Institute&Hospital
  • Zhejiang
    • Jinhua, Zhejiang, China, 321099
      • Jinhua Municipal Hospital Medical Group
      • Contact: Shubo Ding, Master; Phone Number: +8613750983285; Email: jhyyys@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or Female aged 18~75 years old
• Patients with histopathologically or cytologically confirmed advanced or metastatic solid tumors who have failed or are not eligible for standard therapy in the past
• Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• There are measurable tumors(RECIST 1.1)

Exclusion Criteria:

• Previous palliative chemotherapy with docetaxel failed
• Central nervous system metastasis or meningeal metastasis with clinical symptoms
• Has a history of serious cardiovascular disease
• A history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV)
• Active hepatitis B (HBsAg positive, HBV DNA>; ULN) or hepatitis C (HCV antibody positive and HCV RNA>ULN)
• Has a history of allergies to yew medications
• Pregnant or lactating women
• The investigator considered that there were other reasons for the subjects' ineligibility for this clinical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Docetaxel Polymeric Micelles for Injection	Drug: Docetaxel Polymeric Micelles for Injection; Docetaxel polymeric micelles，usage and quantity of Docetaxel polymeric micelles follows the clinical study proctol，not published.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose confirmation stage: Safety and tolerability to determine the subsequent recommended dosing regimen	Incidence of DLT（Dose limited toxicity）	2 years
Expansion stage: effect，ORR(Objective Response Rate ) by investigator	Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose confirmation stage: Objective Response Rate（ORR） by investigator	Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria	2 years
Dose confirmation stage: Objective Response Rate（DoR）by investigator	Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria	2 years
Dose confirmation stage: Progression free survival（PFS） by investigator	PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment according to the RECIST 1.1 criteria	2 years
Dose confirmation stage: Disease Control Rate（DCR）by investigator	Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by investigator according to RECIST 1.1 criteria	2 years
Dose confirmation stage: Overall Survival（OS）by investigator	OS is the time interval from the date of randomization to death from any cause.	2 years
Dose confirmation stage: Area under the plasma concentration versus time curve（AUC）	Area under the plasma concentration versus time curve	Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
Dose confirmation stage: Peak Plasma Concentration（Cmax）	Peak Plasma Concentration，Maximum concentration of HT001 derived from plasma concentration-time profile	Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
Dose confirmation stage: Time to Peak（Tmax）	Time of peak blood concentration of HT001 derived from plasma concentration-time profile	Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
Dose confirmation stage: Half-life（t1/2）	Half-life of HT001 derived from plasma concentration-time profile	Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
Dose confirmation stage: Clearance（CL）	Clearance of HT001 derived from plasma concentration-time profile	Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
Dose confirmation stage: Volume of distribution（Vd）	Volume of distribution of HT001 derived from plasma concentration-time profile	Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
Dose confirmation stage: Mean Residence Time（MRT）	Mean Residence Time of HT001 derived from plasma concentration-time profile	Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
Expansion stage: Objective Response Rate（DoR）by investigator	Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria	2 years
Expansion stage：Progression free survival（PFS） by investigator	PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment according to the RECIST 1.1 criteria	2 years
Expansion stage：Disease Control Rate（DCR）by investigator	Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by investigator according to RECIST 1.1 criteria	1.5 year
Expansion stage：Overall Survival（OS）by investigator	OS is the time interval from the date of randomization to death from any cause.	2 years
Expansion stage: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0	2 years

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (ACTUAL): February 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: B02B00903-DTAX-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No