CTRI/2021/03/032185招募中不适用
A multicenter, open label, randomized, balanced, two treatment, threeperiods, three sequence, reference replicate, crossover, single dose,bioequivalence study of Doxorubicin Hydrochloride Liposome Injection 2mg/mL of ForDoz Pharma Corp., USA with Doxorubicin HydrochlorideLiposome Injection for intravenous infusion 2 mg/mL Manufactured By: SunPharmaceutical Industries Ltd., India, administered in female patients withovarian cancer whose disease has progressed or recurred after platinum basedchemotherapy and who are already receiving or scheduled to start therapywith doxorubicin hydrochloride liposome injection under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 51
- 试验地点
- 23
- 主要终点
- To characterize the pharmacokinetic profile and to assess the Bioequivalence of the test product [Doxorubicin Hydrochloride Liposome Injection for intravenous infusion 2 mg/mL of ForDoz Pharma Corp., USA] to that of reference product [Doxorubicin Hydrochloride Liposome
研究概览
简要总结
The study is designed as a multicenter, open label, randomized, balanced, two treatment, three periods, three sequence, reference replicate, crossover, single dose, bioequivalence study under fasting conditions. Patient with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy with Doxorubicin Hydrochloride Liposome Injection 2 mg/mL will be screened for eligibility assessment. Screening will be done within 10 days preceding first Investigational Medicinal Product (IMP) administration on day 1 of period I. Treatments will be allocated to patient as consecutive three treatment cycles by carrying out randomization using statistical techniques. During the study period, each patient will receive the reference product in any of the two study periods and the test product in remaining one study period. Patients will be randomly allocated to the sequence in which they receive study drug (i.e., either TRR or RTR or RRT).
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 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Non-smoker, female patient 18 to 70 years of age (both inclusive).
- •2.Patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start Doxorubicin Hydrochloride liposomal injection 50 mg per m2 dose as monotherapy as confirmed by treatment and medical history.
- •3.Patients should have recovered from any toxic effects of previous chemotherapy as judged by the investigator.
- •4.Patients with life expectancy of at least 3 months.
- •6.Adequate hemopoeitic, renal and liver function.
- •Body system Parameters Bone marrow function ANC more than or equal 1500/mm Platelet count more than or equal to 100,000/mm Haemoglobin more than or equal to 9.0 g/dL Renal function Serum Creatinine less than or equal to 1.5 times ULN Hepatic function AST and ALT less than 3 times ULN (less than or equal to 5× ULN for liver metastasis) Alkaline phosphatase less than equal 3 times ULN less than or equal to 5 × ULN for bone metastasis) Bilirubin less than to 1.2 mg/dL 7.Sexually active women, unless surgically sterile (with documented evidence of hysterectomy / bilateral salpingectomy / bilateral oophorectomy at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months of spontaneous amenorrhea, must agree to 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] for at least 4 weeks prior to study drug administration, 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.
- •It is investigator‘s responsibility to ensure that above points regarding an effective methods of avoiding pregnancy are discussed with patient in detail and patient agreed for this and it is documented in source document.
- •The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol.
- •8.Patient should able to understand and sign the written informed consent form and willing to follow the study requirements as per protocol.
- •9.Cancer patients receiving stable concomitant medications are allowed to participate, provided: a.
- •The concomitant medication and their dosing regimen is expected to remain same for all the study periods and clearly documented.
- •The concomitant medications do not interfere with the study drug.
排除标准
- •Patients will be excluded from the study, if they meet any of the following criteria: 1.History of allergy or hypersensitivity reactions to a conventional product of Doxorubicin Hydrochloride or the components of Doxorubicin Hydrochloride Liposome Injection or any related compound at any dose or other anthracycline drugs, or granisetron or dexamethasone.
- •2.Patients who require a dose reduction to below 50 mg/m
- •3.Prior history of significant infusion-related reaction.
- •4.Concurrent use of calcium channel blockers or other cardiotoxic Medications such as cyclophosphamide.
- •5.Have received radiotherapy to mediastinal area or who are prone to radiation recall reaction due to recent radiotherapy.
- •6.For female of child bearing potential, positive pregnancy test at screening serum) and prior to dosing urine in period I.
- •7.Prior Doxorubicin exposure that would result in a total lifetime exposure of 550 mg per m2 or more after four cycles of treatment as confirmed by patient s treatment history.
- •(Prior use of other anthracyclines or anthracenodiones should be included in calculations of total cumulative dosage 8.Patient having active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.
- •carinii or other clinically significant infection at screening or within 7 days prior to receiving the study drug.
- •9.Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
- •10.Patients with history of other clinically significant concomitant disease including gastrointestinal, pulmonary, endocrine, immunologic, dermatologic, neurologic, psychological, musculoskeletal, cardiac, liver or renal disease.
- •11.Alcohol or drug abuse or drug dependence within the preceding year.
- •12.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.
- •13.Pregnant or breastfeeding female.
- •14.Patients with any of the below mentioned cardiac risks.
- •Patients will undergo evaluation by a cardiologist prior to study enrollment as applicable: • Resting LVEF of less than or equal 50% Note: Based on clinical suspicion of subclinical LV systolic dysfunction by a Cardiologist/Investigator if required, patients may be referred to other cardiac imaging methods such as strain, strain rate, cardiac MRI or nuclear medicine etc.
- •for further assessment of the cardiac risk.
- •â€¢ History of angina or coronary artery disease • History of myocardial infarction • NYHA (New York State Heart Association) class II-IV heart failure • Clinically significant ventricular arrhythmia or tachyarrhythmia • Clinically significant pericardial disease • Electrocardiographic evidence of acute ischemic or significant conduction system abnormalities • Significant QTc prolongation or other significant ECG abnormalities.
- •â€¢ Any other cardiac illness that could lead to a safety risk to the patient in case of enrollment in the study Known symptomatic or untreated or recently treated less than or equal to 6 months of screening central nervous system CNS metastases.
- •Patients with previously treated more than 6 months of screening CNS metastases and are now stable and asymptomatic are allowed.
- •Pre-existing motor or sensory neurotoxicity of a severity more than or equal to grade 2 by NCI CTCAE criteria.
- •A positive HIV and hepatitis screen including hepatitis B surface antigen and HCV antibodies, syphilis (VDRL or RPR test).
- •17.Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of Investigational Medicinal Product for the current study.
- •Known, existing uncontrolled coagulopathy.
- •19.Physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- •Uncontrolled hypertension (systolic blood pressure [BP] >160 or diastolic BP >100 mm Hg) with or without antihypertensive treatment.
- •Presence of uncontrolled diabetes mellitus (HbA1c ≥ 8 %).
- •Patients who have taken any potent CYP3A4 inhibitors including but not limited to: ketoconazole, itraconazole, troleandomycin, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, nefazodone, fluvoxamine, diltiazem, verapamil, mibefradil, cimetidine and cyclosporine during the study and within 14 days prior to day of first dosing and/or use of drug metabolism enzymes inducers such as phenytoin, carbamazepine, phenobarbital, etc.
- •and any medications that can cause significant myelosuppression (other than liposomal doxorubicin), during the study and within 14 days prior to day of first dosing or 5 half-lives (whichever is greater) have not elapsed prior to receiving the first dose of investigational medicinal product.
- •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
- •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.
结局指标
主要结局
To characterize the pharmacokinetic profile and to assess the Bioequivalence of the test product [Doxorubicin Hydrochloride Liposome Injection for intravenous infusion 2 mg/mL of ForDoz Pharma Corp., USA] to that of reference product [Doxorubicin Hydrochloride Liposome
时间窗: A total of 22 blood samples each of 3.5 mL will be collected during each | period. The pre-infusion blood sample (0.00) will be collected within one hour | prior to the dosing. | After start of intravenous infusion, blood samples (1 x 3.5 ml each) will be | collected at 0.25, 0.50, 0.75, 1.00 (at the end of infusion), 1.25, 1.50, 2.00, 2.50, | 3.00, 3.50, 4.00, 5.00, 6.00, 9.00, 12.00, 24.00, 48.00, 96.00, 168.00, 240.00 | and 336.00 hours
Injection for intravenous infusion 2 mg/mL by Sun Pharmaceutical Industries Ltd., India] in female patients with ovarian cancer
时间窗: A total of 22 blood samples each of 3.5 mL will be collected during each | period. The pre-infusion blood sample (0.00) will be collected within one hour | prior to the dosing. | After start of intravenous infusion, blood samples (1 x 3.5 ml each) will be | collected at 0.25, 0.50, 0.75, 1.00 (at the end of infusion), 1.25, 1.50, 2.00, 2.50, | 3.00, 3.50, 4.00, 5.00, 6.00, 9.00, 12.00, 24.00, 48.00, 96.00, 168.00, 240.00 | and 336.00 hours
次要结局
- To monitor the adverse events and to ensure the safety of patients.(Physical examination,vital signs,ECG,laboratory)
研究者
研究点 (23)
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