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

February 23, 2022 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233099
        • the First Affiliated Hospital of Bengbu Medical College
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • The Forth Hospital of Hebei Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China, 450003
        • Henan Cancer Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410031
        • Hunan Cancer Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Cancer Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200123
        • Shanghai East Hospital
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose confirmation stage: Safety and tolerability to determine the subsequent recommended dosing regimen
Time Frame: 2 years
Incidence of DLT（Dose limited toxicity）
2 years
Expansion stage: effect，ORR(Objective Response Rate ) by investigator
Time Frame: 2 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dose confirmation stage: Objective Response Rate（ORR） by investigator
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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）
Time Frame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
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）
Time Frame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
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 Frame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
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）
Time Frame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
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）
Time Frame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
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）
Time Frame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
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）
Time Frame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 1.5 year
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
Time Frame: 2 years
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)
Time Frame: 2 years
Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Simcere Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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