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Trial Title:
A Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic Cancer
NCT ID:
NCT05616494
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Docetaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Docetaxel for injection (Albumin-bound)
Description:
Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks.
Arm group label:
Docetaxel for Injection (Albumin-bound)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients aged ≥18 years (subject to the date when the informed consent form is
signed) and voluntarily signed the informed consent form.
2. Histologically or cytologically confirmed diagnosis of pancreatic cancer.
3. Patients who have got disease progression or toxic intolerance after previous
standard treatment (gemcitabine based and fluorouracil based therapy).
4. 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).
5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of
0-2.
6. Patients with estimated survival time of ≥ 3 months.
7. 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.
8. 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:
1. Patients who have a history of severe allergy to any excipients of the
investigational drug or taxanes.
2. 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).
3. Patients with partial or complete intestinal obstruction or complete biliary
obstruction that cannot be relieved by active treatment.
4. 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).
5. Patients with brain metastases and meningeal metastases.
6. 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.
7. 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).
8. Patients with a history of severe cardiovascular disease, including but not limited
to:
1. 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;
2. History of myocardial infarction, unstable angina pectoris, angioplasty and
coronary artery bypass surgery within 6 months before the first dose of the
investigational drug;
3. Heart failure with New York Heart Association (NYHA) Classification of Class
III and above;
4. Poorly controlled hypertension (Systolic blood pressure ≥ 160 mmHg and/or
diastolic blood pressure ≥ 100 mmHg at screening period).
9. 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.
10. 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.
11. 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.
12. Patients who have used potent inhibitors or inducers of CYP3A4 within 2 weeks before
the first dose of the investigational drug.
13. 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.
14. Pregnant or nursing women.
15. 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.
16. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
xianjun Yu, Doctor
Phone:
+86-13801669875
Email:
yuxianjun@fudanpci.org
Start date:
December 6, 2022
Completion date:
June 30, 2025
Lead sponsor:
Agency:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Agency class:
Industry
Source:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05616494