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A Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel for injection (Albumin-bound)
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged ≥18 years (subject to the date when the informed consent form is signed) and voluntarily signed the informed consent form. Histologically or cytologically confirmed diagnosis of pancreatic cancer. Patients who have got disease progression or toxic intolerance after previous standard treatment (gemcitabine based and fluorouracil based therapy). At least one measurable lesion according to RECIST v1.1(the measurable lesion area had not received previous radiation therapy or had evidence of definite progression after the end of radiation therapy). Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Patients with estimated survival time of ≥ 3 months. Patients with fine organ function (no medical supportive treatments such as blood component transfusion, growth factors within 2 weeks before taking the relevant inspections): Absolute neutrophil count ≥1.5×10^9/L; Platelets ≥100×10^9/L; Hemoglobin ≥90 g/L; Albumin≥30 g/L; Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 40 mL/min; Total bilirubin≤1.5 × ULN(≤ 2 × ULN for patients with obstructive jaundice, ≤3 × ULN for patients with Gilbert's syndrome); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3× ULN (≤5× ULN for patients with liver metastasis); Prothrombin time (PT) ≤ 1.5×ULN, International Normalized Ratio (INR) ≤ 1.5×ULN. The patient must agree to take adequate contraception from signing of ICF through 6 months after last dose, women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of the investigational drug. Exclusion Criteria: Patients who have a history of severe allergy to any excipients of the investigational drug or taxanes. Patients who had no response to previous taxanes treatments (no tumor shrinkage was observed or disease progressed within 3 months after initiation of the treatment). Patients with partial or complete intestinal obstruction or complete biliary obstruction that cannot be relieved by active treatment. Patients who had a history of other active malignant tumors within 2 years before the first dose of the investigational drug, except for the study disease pancreatic cancer and curable cancer that had been cured (such as basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer or breast cancer in situ that had been excised). Patients with brain metastases and meningeal metastases. Patients with chronic hepatitis B (HBsAg and/or HBcAb positive but HBV DNA < 2000 IU/mL can be included), chronic hepatitis C (HCV antibody positive but HCV RNA negative can be included), and HIV antibody positive. Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0 (except for alopecia, hyperpigmentation, or other toxicity without safety risk judged by the investigator). Patients with a history of severe cardiovascular disease, including but not limited to: Severe heart rhythm or conduction abnormalities, including but not limited to ventricular arrhythmia requiring clinical intervention and third degree atrioventricular block within 6 months before the first dose of the investigational drug; History of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery within 6 months before the first dose of the investigational drug; Heart failure with New York Heart Association (NYHA) Classification of Class III and above; Poorly controlled hypertension (Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening period). Patients with uncontrolled serous cavity effusion requiring frequent drainage or medical intervention (e.g., pleural effusion, abdominal effusion, pericardial effusion, etc., additional intervention was needed within 2 weeks after intervention, excluding exfoliative cytology testing of the exudate) within 7 days before the first dose of the investigational drug. Patients with severe or active infections (including tuberculous infections) that require systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of the investigational drug, antiviral therapy for patients with viral hepatitis is permitted. Patients who have received anti-tumor treatments such as chemotherapy, targeted therapy, immunotherapy and other clinical study drugs within 4 weeks or 5 half-lives of the drugs (whichever is shorter) before the first dose of the investigational drug. Patients who have used potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of the investigational drug. Patients who have undergone major surgery within 4 weeks before the first dose of the investigational drug and had not recovered sufficiently, or who need to undergo elective surgery during the study. Pregnant or nursing women. Patients who is participating in another clinical study simultaneously unless it is an observational (non-interventional) clinical study or within the follow-up period of an interventional study. Other situations that the investigator considers not suitable for participating in the clinical study, including but not limited to: the patient is complicated by severe or uncontrolled medical conditions, which will increase the safety risk, interfere with the interpretation of study results or affect the study compliance.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel for Injection (Albumin-bound)

Arm Description

Docetaxel for Injection (Albumin-bound) will be administrated once every 3 weeks.

Outcomes

Primary Outcome Measures

Overall response rate (ORR) by Independent Review Committee (IRC)

Secondary Outcome Measures

ORR by investigator
Overall survival (OS)
Disease control rate (DCR) by IRC and investigator

Full Information

First Posted
November 7, 2022
Last Updated
March 20, 2023
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05616494
Brief Title
A Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic Cancer
Official Title
A Single-arm, Multicenter, Phase Ⅱ Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic Cancer Who Have Received at Least One Line of Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) in patients with pancreatic cancer.
Detailed Description
Simon two-stage design will be adopted in this study. In the first stage, 24 patients will be enrolled, if at least 2 of them get response (CR or PR), the second stage of the study will be conducted, and 29 additional patients will be enrolled. If there is only one or no patients get response (CR or PR) in the first stage, the study will be early terminated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel for Injection (Albumin-bound)
Arm Type
Experimental
Arm Description
Docetaxel for Injection (Albumin-bound) will be administrated once every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Docetaxel for injection (Albumin-bound)
Intervention Description
Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks.
Primary Outcome Measure Information:
Title
Overall response rate (ORR) by Independent Review Committee (IRC)
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
ORR by investigator
Time Frame
Up to approximately 2 years
Title
Overall survival (OS)
Time Frame
Up to approximately 2 years
Title
Disease control rate (DCR) by IRC and investigator
Time Frame
Up to approximately 2 years
Other Pre-specified Outcome Measures:
Title
Duration of Response (DoR) by IRC and investigator
Time Frame
Up to approximately 2 years
Title
Progression-Free-Survival (PFS) by IRC and investigator
Time Frame
Up to approximately 2 years
Title
Incidence of AE and SAE
Time Frame
Up to approximately 2 years
Title
Plasma concentration of docetaxel (free and total)
Time Frame
At the end of Cycle 1 (each cycle is 21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged ≥18 years (subject to the date when the informed consent form is signed) and voluntarily signed the informed consent form. Histologically or cytologically confirmed diagnosis of pancreatic cancer. Patients who have got disease progression or toxic intolerance after previous standard treatment (gemcitabine based and fluorouracil based therapy). At least one measurable lesion according to RECIST v1.1(the measurable lesion area had not received previous radiation therapy or had evidence of definite progression after the end of radiation therapy). Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Patients with estimated survival time of ≥ 3 months. Patients with fine organ function (no medical supportive treatments such as blood component transfusion, growth factors within 2 weeks before taking the relevant inspections): Absolute neutrophil count ≥1.5×10^9/L; Platelets ≥100×10^9/L; Hemoglobin ≥90 g/L; Albumin≥30 g/L; Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 40 mL/min; Total bilirubin≤1.5 × ULN(≤ 2 × ULN for patients with obstructive jaundice, ≤3 × ULN for patients with Gilbert's syndrome); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3× ULN (≤5× ULN for patients with liver metastasis); Prothrombin time (PT) ≤ 1.5×ULN, International Normalized Ratio (INR) ≤ 1.5×ULN. The patient must agree to take adequate contraception from signing of ICF through 6 months after last dose, women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of the investigational drug. Exclusion Criteria: Patients who have a history of severe allergy to any excipients of the investigational drug or taxanes. Patients who had no response to previous taxanes treatments (no tumor shrinkage was observed or disease progressed within 3 months after initiation of the treatment). Patients with partial or complete intestinal obstruction or complete biliary obstruction that cannot be relieved by active treatment. Patients who had a history of other active malignant tumors within 2 years before the first dose of the investigational drug, except for the study disease pancreatic cancer and curable cancer that had been cured (such as basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer or breast cancer in situ that had been excised). Patients with brain metastases and meningeal metastases. Patients with chronic hepatitis B (HBsAg and/or HBcAb positive but HBV DNA < 2000 IU/mL can be included), chronic hepatitis C (HCV antibody positive but HCV RNA negative can be included), and HIV antibody positive. Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0 (except for alopecia, hyperpigmentation, or other toxicity without safety risk judged by the investigator). Patients with a history of severe cardiovascular disease, including but not limited to: Severe heart rhythm or conduction abnormalities, including but not limited to ventricular arrhythmia requiring clinical intervention and third degree atrioventricular block within 6 months before the first dose of the investigational drug; History of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery within 6 months before the first dose of the investigational drug; Heart failure with New York Heart Association (NYHA) Classification of Class III and above; Poorly controlled hypertension (Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening period). Patients with uncontrolled serous cavity effusion requiring frequent drainage or medical intervention (e.g., pleural effusion, abdominal effusion, pericardial effusion, etc., additional intervention was needed within 2 weeks after intervention, excluding exfoliative cytology testing of the exudate) within 7 days before the first dose of the investigational drug. Patients with severe or active infections (including tuberculous infections) that require systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of the investigational drug, antiviral therapy for patients with viral hepatitis is permitted. Patients who have received anti-tumor treatments such as chemotherapy, targeted therapy, immunotherapy and other clinical study drugs within 4 weeks or 5 half-lives of the drugs (whichever is shorter) before the first dose of the investigational drug. Patients who have used potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of the investigational drug. Patients who have undergone major surgery within 4 weeks before the first dose of the investigational drug and had not recovered sufficiently, or who need to undergo elective surgery during the study. Pregnant or nursing women. Patients who is participating in another clinical study simultaneously unless it is an observational (non-interventional) clinical study or within the follow-up period of an interventional study. Other situations that the investigator considers not suitable for participating in the clinical study, including but not limited to: the patient is complicated by severe or uncontrolled medical conditions, which will increase the safety risk, interfere with the interpretation of study results or affect the study compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe zhang
Phone
13115039707
Email
zhangzhe@mail.ecspc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xianju Xu
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xianjun Yu, Doctor
Phone
+86-13801669875
Email
yuxianjun@fudanpci.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic Cancer

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