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A Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

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

NCT05616494•CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+10 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

December 6, 2022

Primary Completion Date

December 31, 2024

Completion Date

June 30, 2025

Last Updated

March 22, 2023

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

Docetaxel for injection (Albumin-bound)

DRUG

Contacts

Zhe zhang

CONTACT

13115039707 zhangzhe@mail.ecspc.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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