CTRI/2021/03/032185招募中未知
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. - 18-VIN-0553
试验速览
- 阶段
- 未知
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
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.
- •5.ECOG performance status of less than or equal to 2.
- •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 5Ã?â?? ULN for liver metastasis) Alkaline phosphatase less than equal 3 times ULN less than or equal to 5 Ã?â?? 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 investigatorââ?¬Ë?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.
- •b. 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
- •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/m2.
- •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
- •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:
- •Ã¢â?¬Â¢ 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.
- •Ã¢â?¬Â¢ History of angina or coronary artery disease
- •Ã¢â?¬Â¢ History of myocardial infarction
- •Ã¢â?¬Â¢ NYHA (New York State Heart Association) class II-IV heart failure
- •Ã¢â?¬Â¢ Clinically significant ventricular arrhythmia or tachyarrhythmia
- •Ã¢â?¬Â¢ Clinically significant pericardial disease
- •Ã¢â?¬Â¢ Electrocardiographic evidence of acute ischemic or significant
- •conduction system abnormalities
- •Ã¢â?¬Â¢ Significant QTc prolongation or other significant ECG abnormalities.
- •Ã¢â?¬Â¢ Any other cardiac illness that could lead to a safety risk to the patient in
- •case of enroll
研究者
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