A Study of Docetaxel for Injection (Albumin-bound) in Combination With Bevacizumab in Patients With Ovarian Cancer

NCT05325229 | Unknown Phase 2

• 1 other identifier: HB1801-005
• Study Type: interventional
• Target: 94
• 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) combined with Bevacizumab and the pharmacokinetic characteristics of Docetaxel in patients with platinum-resistant recurrent ovarian cancer.

Conditions

Platinum-resistant Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (4)

• Dose escalation trial: Incidence of adverse event(AE)

  Up to approximately 2 years

• Phase II trial: Overall response rate (ORR) by Independent Review Committee(IRC)

  Up to approximately 2 years

• Dose escalation trial: Serious adverse event(SAE )

  Up to approximately 2 years

• Dose escalation trial: Dose limiting toxicity(DLT).

  Up to approximately 2 years

Secondary Outcomes (13)

• Dose escalation trial and Phase II trial: Plasma concentration of docetaxel (free and total

  Up to approximately 3 months

• Phase II trial: ORR by investigator

  Up to approximately 2 years

• Phase II trial: Disease control rate (DCR)

  Up to approximately 2 years

• Phase II trial: Duration of Response (DOR)

  Up to approximately 2 years

• Phase II trial: Progression-Free-Survival (PFS)

  Up to approximately 2 years

Study Arms (1)

Docetaxel combined with Bevacizumab

EXPERIMENTAL

Docetaxel for Injection (Albumin-bound) will be administrated once every 3 weeks at a dose of 75 mg/m\^2 or 100 mg/m\^2; Bevacizumab will be administrated once every 3 weeks at a dose of 15mg/kg.

Drug: Docetaxel for injection (Albumin-bound); Drug: Bevacizumab

Interventions

Docetaxel for injection (Albumin-bound) DRUG

Docetaxel for injection (Albumin-bound), by intravenous infusion，75 mg/m\^2 or 100 mg/m\^2 once every 3 weeks.

Docetaxel combined with Bevacizumab

Bevacizumab DRUG

Bevacizumab, by intravenous infusion, 15 mg/kg once every 3 weeks.

Docetaxel combined with Bevacizumab

Eligibility Criteria

• Age: 18 Years - 78 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18, ≤78 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 epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Patients who responded to their last line of platinum treatment, and the disease recurred or progressed between 28 days to 6 months (184 calendar days) after the last platinum therapy (platinum-resistant disease), with no more than two lines of non-platinum therapy.
• At least one measurable lesion according to RECIST v1.1.
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Patients with estimated survival time of ≥ 3 months.
• Main organ function meets the following criteria within 7 days before treatment (no medical supportive treatments such as blood component transfusion, human granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), interleukin-11, and erythropoietin (EPO) within 2 weeks before administration of the investigational drug):
• Absolute neutrophil count ≥1.5×10\^9/L; Platelets ≥100×10\^9/L; Hemoglobin ≥90 g/L or ≥5.6 mmol/L; Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 40 mL/min; Liver function: total bilirubin≤ 1.0 × ULN, ≤ 1.5 × ULN for patients with liver metastasis; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN, ≤ 2.5 × ULN for patients with liver metastasis.
• Activated Partial Thromboplastin Time (APTT) ≤ 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 received anti-angiogenic therapy (including but not limited to bevacizumab, apatinib, anlotinib, etc.) within 18 weeks before the first use of the investigational drug.
• The progression-free interval of previous docetaxel treatment was less than 6 months.
• Patients whose disease progressed during platinum therapy (from the first dose to 28 days after the last dose).
• Mucinous ovarian cancer or less malignant ovarian tumors (such as low-grade serous ovarian cancer).
• Symptomatic central nervous system (CNS) metastases or cancerous meningitis (Patients may participate in this study if they have completed radiotherapy or surgery for CNS metastases prior to screening, and the patient's nervous system has been stable for ≥4 weeks after radiotherapy or post-surgery (i.e., no new neurological deficits due to brain metastases, no new lesions on CNS imaging, and no treatment is required at screening)).
• History of other malignant tumors within 5 years before the first dose of the investigational drug, except for the following: curable cancer such as basal cell or squamous cell skin cancer, superficial bladder cancer, prostate cancer, cervical cancer or breast cancer in situ that had been cured.
• Patients with a history of thromboembolism, cerebral infarction, hemorrhagic disease or bleeding tendency within 6 months before the first dose of the investigational drug.
• History of intestinal obstruction, gastrointestinal perforation, abdominal fistula or abdominal abscess within 6 months before the first dose of the investigational drug.
• Abdominal or pelvic radiotherapy within 5 years before the first dose of the investigational drug.
• Urine protein \>2+, or urine protein is 2+ with 24-hour urine protein quantitative \>1g at screening.
• Patients who are known to be allergic to the investigational drug or its main excipients.
• Patients with an uncontrollable third space effusion (e.g. pleural effusion, ascites, or pericardial effusion), who, in the judgment of the investigator, are not suitable for the study.
• 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, angina pectoris, angioplasty and coronary artery bypass surgery within 6 months before the first dose of the investigational drug;

Sponsors & Collaborators

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

Study Sites (1)

Tongji Hospital,Tongji Medical College of HUST

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Interventions

Docetaxel; Injections; Bevacizumab

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Drug Administration Routes; Drug Therapy; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xuekun Yao

  CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Zhe Zhang

CONTACT

1315039707; 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: March 24, 2022
• First Posted: April 13, 2022
• Study Start: August 18, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 13, 2022

Record last verified: 2022-03

Locations

CN (1)