CTRI/2021/12/038914招募中1 期
A Randomized, Open-Label, Multicenter, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover Bioequivalence Study Of Doxorubicin Hydrochloride Liposome Injection 2mg/mL (50 mg/m2 dose) Of Alembic Pharmaceuticals Limited, India And PrTaro-DOXOrubicin Liposomal 2mg/mL (Pegylated Liposomal Doxorubicin Hydrochloride for Injection) (50 mg/m2 dose) Of Taro Pharmaceuticals Inc, 130 East Drive, Brampton, Ontario, Canada, L6T 1C1, Administered in Patient With Advanced Ovarian Cancer Under Standard diet (non-high-fat) Conditions.
试验速览
- 阶段
- 1 期
- 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
- Interventional
入排标准
入选标准
- •1.Willing and able to provide written informed consent.
- •2.Female patient between 18 and 65 years of age, both inclusive and having Body Mass Index (BMI) ââ?°Â¥ 17.00 kg/m2.
- •3.Documented diagnosis (histological confirmation) of ovarian cancer.
- •4.Patient with documented progressive or recurrent disease after treatment with platinum-based chemotherapy.
- •5.The patient is eligible and clinically indicated to receive the recommended minimum 2 cycles of Liposomal Doxorubicin HCl, without exceeding a lifetime cumulative dosage of 450 mg/m2. (Prior use of conventional or liposomal doxorubicin formulations, in addition to the use of other anthracyclines or anthracenediones should be included in calculations of total lifetime cumulative dose)
- •6.Eastern Cooperative Oncology Group (ECOG) performance status of ââ?°Â¤ 2.
- •7.The life expectancy of > 180 days.
- •8.No toxic effects of previous chemotherapy as judged by the Investigator.
- •9.Patient whose organ and immune system functions are adequate as indicated by the following laboratory values or considered by the Investigator/sub-Investigator to be of no clinical significance.
- •Hematologic
- •Absolute neutrophil count (ANC)ââ?°Â¥ 1.5 X 109/L
- •Plateletsââ?°Â¥ 100 X 109/L
- •Hemoglobinââ?°Â¥ 9.0 g/dL
- •Total bilirubinââ?°Â¤ 1.3 mg/dL
- •(ââ?°Â¤2 mg/dL for liver metastasis)
- •Alanine aminotransferase (ALT)ââ?°Â¤ 2.5 X ULN
- •(ââ?°Â¤ 4 Ã?â?? ULN for liver metastasis)
- •Aspartate aminotransferase (AST)ââ?°Â¤ 2.5 X ULN
- •(ââ?°Â¤ 4 Ã?â?? ULN for liver metastasis)
- •Alkaline phosphataseââ?°Â¤ 2.5 X ULN
- •(ââ?°Â¤ 5 Ã?â?? ULN for bone metastasis and ââ?°Â¤4Ã?â??ULN for liver metastasis)
- •Serum creatinine < 1.5 x upper limit of normal (ULN)
- •Creatinine clearanceââ?°Â¥ 30 mL/min
- •10.Patient with cardiac ejection fraction ââ?°Â¥ 50% as measured by an echocardiogram (ECHO).
- •11.Patient must have clinically acceptable results for all the screening parameters and investigations.
- •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.
- •13.Willing to abstain from consuming grapefruit, citrus fruits, and its products 72 hours before randomization and throughout the study period
- •14.Willing to abstain from consuming any xanthine containing items (i.e., tea, coffee, cola drinks, or chocolate/coca, etc.) for 48 hours before randomization and throughout the study period
- •15.Availability of patient for the entire study duration and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •16.No history of addiction to any recreational drug or drug dependence or alcohol addiction.
- •17.Female patient
- •a) of childbearing potential practicing an acceptable method of birth control such as sexual abstinence, (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 a condom with spermicide by a sexual partner or sterile [at least 6 months before Investigational Product administration] sexual partner) for at least 4 weeks before
排除标准
- •1.Pregnant and lactating female.
- •2.Patient with a history of known hypersensitivity or contraindication to conventional or liposomal formulations of doxorubicin, anthracycline therapy, or to any of their components.
- •3.Received liposomal doxorubicin HCl in the past and had a required dose reduction to below 50mg/m2, or whose disease has progressed or recurred after treatment with liposomal doxorubicin.
- •4.Patient whose total cumulative dose of doxorubicin HCl approaches 450 mg/m2.
- •5.Patient with brain metastases.
- •6.Pre-existing motor or sensory neurotoxicity of a severity ââ?°Â¥ grade 2 by NCI criteria.
- •7.Patient with significantly impaired hepatic function.
- •8.Patient with clinically significant cardiac, liver or kidney disease.
- •9.Patient with history or presence of uncontrolled diabetes mellitus.
- •10.Patient having active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganism if under treatment with myelotoxic drugs.
- •11.Patient with impaired cardiac function including any of the following condition within past 6 months (To be judged based on the discretion of Investigator):
- •Ã¢â?¬Â¢Unstable angina or Myocardial infarction
- •Ã¢â?¬Â¢Significant ECG abnormalities
- •Ã¢â?¬Â¢Coronary artery bypass graft surgery
- •Ã¢â?¬Â¢Symptomatic peripheral vascular disease
- •Ã¢â?¬Â¢NYHA class II-IV heart failure
- •Ã¢â?¬Â¢Severe uncontrolled ventricular arrhythmias
- •12.Received any prior mediastinal irradiation (as cardiac toxicity may occur at cumulative doses lower than 400 mg/m2).
- •13.Patients who have taken any potent CYP3A4 inhibitors/inducers during the study and within ââ?°Â¤ 30 days before the day of first dosing including but not limited to: inhibitors - Ketoconazole, Itraconazole, Troleandomycin, Clarithromycin, Erythromycin, Ritonavir, Indinavir, Nelfinavir, Saquinavir, Amprenavir, Nefazodone, Fluvoxamine, Diltiazem, Verapamil, Mibefradil, Cimetidine, Cyclosporine; inducers - such as phenytoin, carbamazepine, phenobarbital, etc.
- •14.Patient with the use of Paclitaxel, Progesterone, Verapamil, Cyclosporine, Dexrazoxane, Cytarabine, Streptozocin as concurrent therapy.
- •15.Abnormal baseline findings are considered by the investigator to indicate conditions that might affect study endpoints.
- •16.Patients who have taken vaccination for COVID within 14 days before the day of first dosing.
- •17.Smoking (ââ?°Â¥ 10 cigarettes/day) or consumption of tobacco products (ââ?°Â¥ 4 chews/day)
- •18.Alcohol dependence, alcohol abuse, or drug abuse or addiction to any recreational drug within the past year.
- •19.Any other significant medical comorbidities or intercurrent illnesses or infections may have an impact on patient safety and do not permit the dosing of Doxorubicin HCl as determined by the Investigator.
- •20.Clinically assessed as having inadequate venous access for PK sampling.
- •21.Patient deemed uncooperative or non-compliant.
- •22.Patient who has shown positive results in urine alcohol test and/or urine drug screening test.
- •23.Significant abnormal 12 lead ECG, X-ray, and 2D-Echocardiography finding.
- •24.A positive result of HIV, HCV, RPR, and HBsAg.
- •25.Participation in another clinical trial within the preceding 90 days of study starts.
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