AzTrials
AzTrials

Advanced Solid TumorsPhase 2NCT05254665

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

A Phase 2 study testing Docetaxel Polymeric Micelles for Injection in people with Advanced Solid Tumors, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 10 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
Docetaxel Polymeric Micelles for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
10 sitesChina
Study dates
Feb 2022to Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

Hongmei Lin, Ph.D contact

+8615910575714

linhongmei@simcere.com

Zhi Zhang, Bachelor contact

+8618670738874

zhangzhi4@simcere.com

10 sites in 1 country

China10 sites

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233099

    Duojie Li, Master, +8613956332626, liduojie@163.com

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

    Hui Wang, Ph.D, +8613973135460, Wanghui710327@163.com

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Bo liu, Master, +8615553115688, 15553115688@163.com

  • Jinhua Municipal Hospital Medical Group

    Jinhua, Zhejiang, 321099

    Shubo Ding, Master, +8613750983285, jhyyys@163.com

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

    Hui Luo, Master, +8613707917606, luohui65001@163.com

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123

    Ye Guo, Ph.D, +8613501678472, pattrickguo@gmail.com

    Ye Guo, Ph.D

  • The Forth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Jun Wang, Ph.D, +8613931182128, wangjunzr@163.com

  • Tianjin Medical University Cancer Institute&Hospital

    Tianjin, Tianjin Municipality, 300181

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Suxia Luo, Ph.D, +8618638553211, luosxrm@163.com

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Yanru Qin, Ph.D, +8613676932999, yanruqin@163.com

Other trials in China

About this study

Official title: 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.

Being tested
Docetaxel Polymeric Micelles for Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel Polymeric Micelles for InjectionDrug

    Docetaxel polymeric micelles，usage and quantity of Docetaxel polymeric micelles follows the clinical study proctol，not published.

Study groups in NCT05254665
Study groupRoleWhat they receive
Docetaxel Polymeric Micelles for InjectionExperimentalDocetaxel Polymeric Micelles for Injection
Receives: Drug: Docetaxel Polymeric Micelles for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose confirmation stage: Safety and tolerability to determine the subsequent recommended dosing regimen

    Incidence of DLT（Dose limited toxicity）

    Measured: 2 years

  2. 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

    Measured: 2 years

Secondary outcomes (17)

  1. 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

    Measured: 2 years

  2. 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

    Measured: 2 years

  3. 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

    Measured: 2 years

  4. 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

    Measured: 2 years

  5. Dose confirmation stage: Overall Survival（OS）by investigator

    OS is the time interval from the date of randomization to death from any cause.

    Measured: 2 years

  6. Dose confirmation stage: Area under the plasma concentration versus time curve（AUC）

    Area under the plasma concentration versus time curve

    Measured: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）

  7. Dose confirmation stage: Peak Plasma Concentration（Cmax）

    Peak Plasma Concentration，Maximum concentration of HT001 derived from plasma concentration-time profile

    Measured: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）

  8. Dose confirmation stage: Time to Peak（Tmax）

    Time of peak blood concentration of HT001 derived from plasma concentration-time profile

    Measured: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）

  9. Dose confirmation stage: Half-life（t1/2）

    Half-life of HT001 derived from plasma concentration-time profile

    Measured: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）

  10. Dose confirmation stage: Clearance（CL）

    Clearance of HT001 derived from plasma concentration-time profile

    Measured: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）

  11. Dose confirmation stage: Volume of distribution（Vd）

    Volume of distribution of HT001 derived from plasma concentration-time profile

    Measured: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）

  12. Dose confirmation stage: Mean Residence Time（MRT）

    Mean Residence Time of HT001 derived from plasma concentration-time profile

    Measured: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）

  13. 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

    Measured: 2 years

  14. 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

    Measured: 2 years

  15. 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

    Measured: 1.5 year

  16. Expansion stage：Overall Survival（OS）by investigator

    OS is the time interval from the date of randomization to death from any cause.

    Measured: 2 years

  17. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2022
  2. Study startFeb 2022 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05254665
Sponsor's protocol ID
B02B00903-DTAX-201
Status last verified
Feb 2022
First submitted
19 Jan 2022
Last updated
24 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel Polymeric Micelles for Injection in people with Advanced Solid Tumors, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hongmei Lin, Ph.D (+8615910575714, linhongmei@simcere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose confirmation stage: Safety and tolerability to determine the subsequent recommended dosing regimen (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05254665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in