A Single-arm, Multicenter, Phase II Clinical Study of Docetaxel for Injection (Albumin-bound) in Combination With Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Overview
- Phase
- Phase 2
- Intervention
- Docetaxel for injection (Albumin-bound)
- Conditions
- Platinum-resistant Recurrent Ovarian Cancer
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Phase II trial: Overall response rate (ORR) by Independent Review Committee(IRC)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Detailed Description
This study will be conducted in two stages (dose escalation trial and phase II trial). Dose escalation trial: To explore the safety and tolerability of Docetaxel for Injection (Albumin-bound) (75 mg/m\^2 and 100 mg/m\^2) combined with Bevacizumab 15 mg/kg. Dose escalation will be started at low dose and proceed in turn. Phase II trial: According to the recommended phase II dose (RP2D) determined in the dose escalation trial, a phase II study of Docetaxel for Injection (Albumin-bound) combined with Bevacizumab will be conducted to observe the efficacy of the combination regimen, with overall response rate (ORR) as the primary study endpoint. Simon's optimal 2-stage design will be adopted for phase II study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Docetaxel combined with Bevacizumab
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.
Intervention: Docetaxel for injection (Albumin-bound)
Docetaxel combined with Bevacizumab
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.
Intervention: Bevacizumab
Outcomes
Primary Outcomes
Phase II trial: Overall response rate (ORR) by Independent Review Committee(IRC)
Time Frame: Up to approximately 2 years
Dose escalation trial: Incidence of adverse event(AE)
Time Frame: Up to approximately 2 years
Dose escalation trial: Serious adverse event(SAE )
Time Frame: Up to approximately 2 years
Dose escalation trial: Dose limiting toxicity(DLT).
Time Frame: Up to approximately 2 years
Secondary Outcomes
- Phase II trial: ORR by investigator(Up to approximately 2 years)
- Phase II trial: Overall survival (OS)(Up to approximately 2 years)
- Phase II trial: abnormal laboratory tests(Up to approximately 2 years)
- Dose escalation trial and Phase II trial: Plasma concentration of docetaxel (free and total(Up to approximately 3 months)
- Phase II trial: Eastern Cooperative Oncology Group（ECOG） scores(Up to approximately 2 years)
- Phase II trial: Disease control rate (DCR)(Up to approximately 2 years)
- Phase II trial: abnormal physical examination(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)
- Phase II trial: CA125 response rate(Up to approximately 2 years)
- Phase II trial: Incidence of AE(Up to approximately 2 years)
- Phase II trial: abnormal vital signs(Up to approximately 2 years)
- Phase II trial: abnormal electrocardiogram(Up to approximately 2 years)