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临床试验/CTRI/2015/10/006241
CTRI/2015/10/006241已完成未知

A multicenter, open label, randomized, two-treatment, two-period,two-sequence, single dose, cross-over bioequivalence study ofDoxorubicin Hydrochloride (Pegylated liposomal concentrate for solution for infusion 20 mg/10mL (2 mg/ml) of Dr. Reddyâ??s Laboratories Ltd, India, with that of Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal) concentrate forsolution for infusion (20 mg/10mL)] of Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium in advancedovarian cancer or metastatic breast cancer patients under fed condition. - 15-VIN-616

Dr Reddys Laboratories Limited0 个研究点目标入组 65 人开始时间: 待定最近更新:
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试验速览

阶段
未知
状态
已完成
入组人数
65
研究概览入排标准研究者记录与标识符相似试验

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. Females of Indian Nationality, between 18-65 years of age (both inclusive).
  • •2. Ability to understand and provide written informed consent prior to participation in the study.
  • •3. Patients with advanced ovarian cancer requiring Doxorubicin and who have failed a first-line platinum-based chemotherapy regimen. Or As monotherapy for patients with metastatic breast cancer.
  • •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 3 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 >= 1500/mm3
  • •Platelet count >= 100,000/mm3
  • •Haemoglobin >= 9.0 g/dl
  • •Renal function:
  • •S. Creatinine < 1.5 x upper limit of normal ULN)
  • •Hepatic function:
  • •AST and ALT <= 2.5 Ã? ULN (<= 4 Ã? ULN for liver metastasis)
  • •Alkaline phosphatase < 2 x ULN (<= 5 Ã? ULN for bone metastasis).
  • •Total Bilirubin <= 1.5 Ã? ULN
  • •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 have negative pregnancy test at screening as well as prior to check-in and 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 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. It is investigator responsibility to ensure that above points regarding an effective method 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.

排除标准

  • •1. Patients who are pregnant or breast feeding.
  • •2. Patients with an ECOG (Eastern Cooperative Oncology group)Performance Status Score > 3.
  • •3. If total cumulative dose of Doxorubicin HCl approaches 450 mg/m2
  • •4. Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.carinii or other microorganism if under treatment with myelotoxic drugs.
  • •5. Any other clinically significant liver or kidney disorders other than mentioned in the selection criteria.
  • •6. Impaired cardiac function including any of the following conditions within past 6 months:
  • •a. Unstable angina
  • •b. QTc prolongation 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.
  • •7. History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride or the components of Caelyx®.
  • •8. Use of any recreational drugs or history of drug addiction.
  • •9. Known brain metastasis.
  • •10. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by NCI criteria.
  • •11. Other serious illness or medical condition that would prohibit the understanding and giving of informed consent.
  • •12. A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
  • •13. A positive test result for HIV antibody and/or syphilis.
  • •14. The receipt of an investigational product, or participation in a drug research study within a period of 90 days prior to the first dose of
  • •investigational Product.
  • •15. Any other condition that, in the investigator judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
  • •16. Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
  • •17. 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.
  • •18. 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.
  • •19. Uncontrolled hypertension (systolic blood pressure [BP] >180 or diastolic BP >100mm Hg) or uncontrolled cardiac arrhythmias (Patients with hypertension controlled by antihypertensive therapies are eligible).
  • •20. 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).
  • •21. Mental condition that would prevent patient comprehension of the nat

研究者

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