CTRI/2022/06/043101招募中不适用
A multicenter, open label, balanced, randomized, two-treatment, three-period, three sequence, partial replicate, single dose, cross-over bioequivalence study of Doxorubicin Hydrochloride pegylated liposomal 2 mg/ml concentrate for solution for infusion (20 mg/10 ml) of TTY Biopharm Company Ltd., Taiwan R. O. C. with that of Caelyx (Doxorubicin Hydrochloride) pegylated liposomal 2 mg/ml concentrate for solution for infusion (20 mg/10 ml) of Baxter Holding B.V., Netherlands in advanced ovarian cancer patients who have failed a first-line platinum based chemotherapy regimen and/or patients with metastatic breast cancer patients under fed (standardized light meal) condition.
TTY Biopharm Company Ltd17 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2022年6月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 17
- 主要终点
- To assess the bioequivalence of the sponsor’s test product
研究概览
简要总结
The study consists of 3periods. Each patient will receive two doses of reference product and one doseof test product in the dose of 50 mg/m2 BSA in a crossover mannerbased on the randomization schedule.
The dosing schedule will beas follows:
Period I (Day 1): Patientswill receive 50 mg/m2 dose of Doxorubicin Hydrochloride pegylatedliposomal concentrate for solution for infusion (either test or referenceproduct) on the first day of the chemotherapy cycle under fed condition. (Day1).
Period II (Day 29): Patientswill receive 50 mg/m2 dose of Doxorubicin Hydrochloride pegylatedliposomal concentrate for solution for infusion (either test or referenceproduct) on the first day of the next chemotherapy cycle under fed condition.
Period III (Day 57): Patients will receive 50 mg/m2dose of Doxorubicin Hydrochloride pegylated liposomal concentrate for solutionfor infusion (either test or reference product) on thefirst day of the next chemotherapy cycle under fed condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female patients between 18-65 years of age (both inclusive).
- •2.Ability to understand and provide written informed consent given before the initiation of the pre-study screening prior to participation in the study.
- •3.Patients with advanced ovarian cancer who have failed a first-line platinum-based chemotherapy regimen And/or Patients with metastatic breast cancer who require Doxorubicin Hydrochloride (Pegylated liposomal) for treatment that are already receiving or scheduled to start Doxorubicin Hydrochloride (Pegylated liposomal) in the dose of 50 mg/m2 dose as monotherapy.
- •4.Cardiac function (left ventricular ejection fraction [LVEF]) ≥50%.
- •5.Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
- •6.Patients with life expectancy of at least 6 months.
- •7.Able to comply with study requirement in opinion of Principal Investigator.
- •8.Adequate Hematopoietic, Renal and Liver function defined as the following: Bone marrow function: ANC more than or equal 1500/mm3 Platelet count more than equal 100,000/mm3 Haemoglobin ≥ 9.0 g/dl Renal function:Serum Creatinine ≤ 1.5 x ULN Hepatic function AST and ALT ≤ 3 x ULN (≤5× ULN for liver metastasis) Alkaline phosphatase ≤ 2.5 x ULN (≤5 × ULN for bone metastasis and ≤4 × ULN for liver metastasis) Total Bilirubin < 1.2 mg/dL (≤4 × ULN for liver metastasis) 9.Adequate recovery from recent surgery.
- •At least 1 week must have elapsed from the time of minor surgery; at least 4 weeks must have elapsed from the time of major surgery.
- •10.Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) during study and up to 6 months after the last dose of study drug.
- •Cessation of birth control after this point should be discussed with a responsible physician.
排除标准
- •1.Patients who are: •Pregnant •Breast feeding •Of childbearing potential with a positive pregnancy test at screening (serum) and prior to dosing (urine) in Period I.
- •â€¢Female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial 2.Patients with an ECOG (Eastern Cooperative Oncology group) Performance Status Score >
- •3.If total cumulative dose (lifetime exposure) of Doxorubicin approaches 450 mg/m
- •4.Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.carinii or other microorganism if under treatment with myelotoxic drugs.
- •5.Clinically significant liver or kidney disorders.
- •6.Patients with severe ascites and pleural exudates.
- •7.Impaired cardiac function including any of the following conditions within past 6 months: a.Unstable angina b.QTc prolongation (>450 msec) or other significant ECG abnormalities.
- •c.Coronary artery bypass graft surgery.
- •d.Symptomatic peripheral vascular disease.
- •e.Myocardial infarction f.NYHA class II-IV heart failure g.Severe uncontrolled ventricular arrhythmias h.Clinically significant pericardial disease i.Electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
- •j.Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if their disease has been stable for the past six months.
- •k.Severe uncontrolled arrhythmias.
- •8.History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride pegylated liposomal or the components of Caelyx®.
- •9.Use of any recreational drugs or history of drug addiction.
- •10.Known brain metastasis.
- •11.Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI criteria.
- •12.Other serious illness or medical condition that would prohibit the understanding and giving of informed consent.
- •13.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
- •14.A positive test result for HIV antibody and/or syphilis (VDRL/RPR) test.
- •15.The receipt of an investigational product (other than doxorubicin hydrochloride liposome injection), or participation in a drug research study within a period of 30 days or 5 half lives (whichever is greater) prior to receiving the first dose of investigational medicinal product in the study.
- •16.Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •17.Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
- •18.Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
- •19.History of donation of blood/loss of blood (without replenishment) (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
- •20.Uncontrolled hypertension (systolic blood pressure [BP] >160 or diastolic BP >100mm Hg) or uncontrolled cardiac arrhythmias (Patients with hypertension controlled by antihypertensive therapies are eligible).
- •21.History of cerebrovascular accident (CVA), MI within 6 months or venous thrombosis within 12 weeks.
- •(Patients with previous history of venous thrombosis on a stable dose of anticoagulation are allowed).
- •22.Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- •23.Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a disease free survival ≥5 years.
- •24.Patients who have taken any potent CYP3A4 inhibitors/inducers ≤14 days prior to enrollment including but not limited to: ketoconazole, itraconazole, troleandomycin, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, nefazodone, fluvoxamine, diltiazem, verapamil, mibefradil, cimetidine, cyclosporine, grapefruit juice and pomelo-containing food or fluids.
- •25.Patients are unable to abstain prohibited medication during the study.
结局指标
主要结局
To assess the bioequivalence of the sponsor’s test product
时间窗: A total of 23 blood samples will be collected during each period. | The pre-infusion blood sample of 3.5 mL (0h) will be collected within one hour prior to start of infusion. | From the start of infusion i.e. during infusion is ongoing: 0.25h (15 min), 0.5h (30 min), 0.75h (45 min). | After completion of infusion: immediately after end of infusion, 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00, 168.00, 336.00 and 504.00 hrs.
次要结局
- To monitor the safety of the patients, who are(exposed to the Investigational Medicinal Product)
研究者
研究点 (17)
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