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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05254665
• Other study ID #: B02B00903-DTAX-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2022
• Est. completion date: March 2024

Study information

• Verified date: February 2022
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: Hongmei Lin, Ph.D
• Phone: +8615910575714
• Email: linhongmei[@]simcere.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: March 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• Docetaxel Polymeric Micelles for Injection
Docetaxel polymeric micelles,usage and quantity of Docetaxel polymeric micelles follows the clinical study proctol,not published.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Hunan Cancer Hospital	Changsha	Hunan
China	Shandong Cancer Hospital	Jinan	Shandong
China	Jinhua Municipal Hospital Medical Group	Jinhua	Zhejiang
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	Shanghai East Hospital	Shanghai	Shanghai
China	The Forth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Medical University Cancer Institute&Hospital	Tianjin	Tianjin
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose confirmation stage: Safety and tolerability to determine the subsequent recommended dosing regimen	Incidence of DLT(Dose limited toxicity)	2 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Expansion stage:Overall Survival(OS)by investigator	OS is the time interval from the date of randomization to death from any cause.	2 years
Secondary	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