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

NCT05616494 | Unknown Phase 2

• 1 other identifier: HB1801-006
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

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

  Up to approximately 2 years

Secondary Outcomes (3)

• ORR by investigator

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

• Disease control rate (DCR) by IRC and investigator

  Up to approximately 2 years

Other Outcomes (4)

• Duration of Response (DoR) by IRC and investigator

  Up to approximately 2 years

• Progression-Free-Survival (PFS) by IRC and investigator

  Up to approximately 2 years

• Incidence of AE and SAE

  Up to approximately 2 years

Study Arms (1)

Docetaxel for Injection (Albumin-bound)

EXPERIMENTAL

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

Drug: Docetaxel for injection (Albumin-bound)

Interventions

Docetaxel for injection (Albumin-bound) DRUG

Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks.

Docetaxel for Injection (Albumin-bound)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Docetaxel; Injections

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• xianju Xu

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe zhang

CONTACT

13115039707; zhangzhe@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 15, 2022
• Study Start: December 6, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: March 22, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)