CTRI/2017/03/008179已完成未知
A randomized, multicenter, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of doxorubicin hydrochloride liposome injection for intravenous infusion 20 mg/10 ml (50mg/m2) of Panacea Biotec Ltd., India (investigational product) and doxorubicin hydrochloride liposome injection for intravenous infusion 20 mg/10 ml (50mg/m2) of Sun Pharmaceutical Industries ltd. (Reference drug), in patients with advanced ovarian cancer - NA
Panacea Biotech Ltd0 个研究点目标入组 32 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 32
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. Female patients between 18-65 years of age. (Both Inclusive)
- •2. Patients must be able to understand the investigational nature of this study and to give
- •written informed consent prior to the participation in the trial.
- •3. Patients with histopathologically /cytologically confirmed Ovarian Cancer requiring
- •Doxorubicin
- •4. Patient with Ovarian Cancer whose disease has progressed or recurred after Platinum-based
- •Chemotherapyand who are already receiving or scheduled to start the therapy with
- •Doxorubicin.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
- •6. Cardiac function (left ventricular ejection fraction [LVEF] >=50%.
- •7. Patient should have recovered from any toxic effects of previous chemotherapy as judged by
- •the Investigator.
- •8. Patients with life expectancy of at least 3 months.
- •9. Able to comply with study requirement in opinion of Investigator.
- •10. Adequate hematologic status, Renal and Liver function.
- •A]Hematologic status:
- •ANC >= 1500/mm3
- •Platelet count >= 100,000/mm3
- •Haemoglobin >= 9.0 g/dl
- •B]Renal function Serum Creatinine < 1.5 times ULN.
- •C]Hepatic Function:
- •AST and ALT < 2.5 times ULN
- •Alkaline phosphatase < 2 times ULN
- •phosphatase < 2 times ULN
- •Bilirubin < ULN
- •11. 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) for at least 12 weeks prior to study drug administration,
- •during study and up to 30 days after the last dose of compassionate medications. Cessation
- •of birth control after this point should be discussed with a responsible physician.
- •The investigator should ensure that the patient is using an effective method of avoiding
- •pregnancy as per protocol.
- •12. 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.
排除标准
- •1. Pregnant or breast-feeding female.
- •2. Prior Doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment
- •3. Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.carinii or other microorganism if under treatment with myelotoxic drugs.
- •4. Significantly impaired hepatic function and kidney function.
- •5. Impaired cardiac function including any of the following conditions within past 6 months:
- •i. Unstable angina
- •ii. QTc prolongation or other significant ECG abnormalities.
- •iii. Coronary artery bypass graft surgery.
- •iv. Symptomatic peripheral vascular disease.
- •v. Myocardial infarction
- •vi. NYHA class II-IV heart failure
- •vii. Severe uncontrolled ventricular arrhythmias
- •viii. Clinically significant pericardial disease
- •ix. Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- •x. 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.
- •xi. Severe uncontrolled arrhythmias.
- •6. History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride or the components of Doxorubicin Hydrochloride liposome injection.
- •7. Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines, cannabinoids and morphine) or history of drug addiction.
- •8. Known brain metastasis.
- •9. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by NCI criteria.
- •10. Other serious illness or medical condition that would prohibit the understanding and giving of informed consent.
- •11. A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies.
- •12. Known cases of HIV and/or syphilis.
- •13. The receipt of an investigational product, or participation in a drug research study within a period of 30 days prior to the first dose of investigational Product (Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study).
- •14. Any other condition/Abnormal baseline that, in the investigatorâ??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.
- •15. Donation / loss of blood (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine.
- •16. 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).
- •17. History of cerebrovascular accident (CVA), MI within 06 months or venous thrombosis within 12 weeks. (Patients with previous history of venous thrombosis on a stable dose of anticoagulation are allowed.)
- •18. Patients who are smokers or tobacco users in any form.
- •19. Past or current history of neoplasm other than the Ovarian Cancer and with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix.
- •20. Patients must not have taken any potent CYP3A4 inhibitors/inducers <= 30 days prior to enrolment including but not limited to: Ketoconazole, Itraconazole, Troleandomycin, Clarithromycin, Erythrom
研究者
相似试验
暂停
不适用
Bioequivalence study of Paliperidone Palmitate in schizophrenia patientsCTRI/2019/02/017754Amneal Pharmaceuticals Company GmbH
尚未招募
Unknown
This is a drug concentration assessment study of Azacitidine 300 mg tablets in patients with Blood Cancer (Acute Myeloid Leukemia).CTRI/2024/03/064636PLIVA Croatia Ltd
已完成
不适用
To compare bioavailibility of Methotrexate Tablets 2.5 mg( Actavis LLC) with Methotrexate Tablets USP 2.5 mg (DAVA Pharmaceuticals, Inc.USA) in patients with mild to severe psoriasis or rheumatoid arthritis, who are already on establishedregimens of 2.5 mg every 12 hours under fasting condition.CTRI/2015/05/005737Actavis LLC42
招募中
不适用
To compare bioavailibility of Methotrexate Tablets 2.5 mg( Amneal pharmaceuticals) with MethotrexateTablets USP 2.5 mg (DAVA Pharmaceuticals, Inc.USA) in patients with mild to severe psoriasisor rheumatoid arthritisCTRI/2016/06/007034Amneal Pharmaceuticals USA48
已完成
不适用
Two treatment Bioequivalence study of Methotrexate 2.5 mg in patients with Rheumatoid Arthritis (RA).CTRI/2022/09/045447Elite Pharmaceuticals48