CTRI/2023/01/048827已完成3 期
A Multicenter, Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover Bioequivalence Study between two formulations of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) [Doxopeg® manufactured by FAPASA - Farmaceutica Paraguay S.A. and registered by Zodiac Produtos Farmacêuticos S.A. (test formulation) and Caelyx® manufactured by Janssen Pharmaceutica NV (reference formulation)] in Patients with Advanced Ovarian Cancer or Metastatic Breast Cancer.
Zodiac Produtos Farmacêuticos S.A.20 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2023年1月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 20
- 主要终点
- To characterize the pharmacokinetic profile
研究概览
简要总结
A Multicenter, Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover Bioequivalence Study between two formulations of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) [Doxopeg® manufactured by FAPASA - Farmaceutica Paraguay S.A. and registered by Zodiac Produtos Farmacêuticos S.A. (test formulation) and Caelyx® manufactured by Janssen Pharmaceutica NV (reference formulation)] in Patients with Advanced Ovarian Cancer or Metastatic Breast Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply: 1 Participant must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study.2 Female participant must be 18 to 75 years of age (both inclusive), at the time of signing the informed consent.3 Participant meeting one of the following criteria-a Participant with documented advanced ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy AND who are already receiving or scheduled to start the monotherapy with liposomal doxorubicin (pegylated) at a dose of 50 mg/m
- •b.Participants with documented metastatic breast cancer AND who are already receiving or scheduled to start the monotherapy with liposomal doxorubicin (pegylated) at a dose of 50 mg/m2.4 Life expectancy of more than or equal to 12 weeks at screening visit.5 An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 at screening visit.6.Participant should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
- •Participants who are already receiving liposomal doxorubicin (pegylated) at a dose of 50 mg/m2 should not require dose reduction(s) in next planned cycle in the study due to toxicity as per the Summary of Product Characteristics (SmPC).7 A participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies-a Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4 b Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of more than 1% per year), with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least six months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for at least six months after the last dose of study intervention.
- •The investigator should evaluate the effectiveness and the potential for contraceptive method failure (eg, noncompliance, recently initiated) of the contraceptive method in relationship to the first dose of study intervention.•A WOCBP must have a negative highly sensitive serum pregnancy test at screening; and urine pregnancy test within 24 hours before the first dose of study intervention.
- •â€¢ If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
- •In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.• Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.6.The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •8 Participant with adequate hematologic, renal and liver function at screening visit.
- •a Absolute Neutrophil Count (ANC) more than or equal to 1500/mm3 b Platelet count more than or equal to 75000/mm3,c Hemoglobin more than or equal to 9.0 g/dL.d Estimated Glomerular Filtration Rate (eGFR) of more than or equal to 30 mL/min/1.73 m2 by the CKD-EPI formula e Total Bilirubin less than 1.2 mg/dLf AST and ALT less than or equal to 2.5 × ULN (less than or equal to 4 × ULN for liver metastasis)9 Participant willing and able to adhere to the lifestyle restrictions specified in this protocol.c Hemoglobin less than or equal to 9.0 g/dL d Estimated Glomerular Filtration Rate (eGFR) of less than or equal to 30 mL/min/1.73 m2 by the CKD-EPI formulae Total Bilirubin less than 1.2 mg/dLf AST and ALT less than or equal to 2.5 × ULN ( less than or equal to 4 × ULN for liver metastasis).
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:1 Documented medical history of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the wellbeing) or that could prevent, limit, or confound the protocol-specified assessments.2 Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components/ excipients thereof (refer to the SmPC), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.3 Prior doxorubicin exposure that would result in a total lifetime exposure of 450 mg/m2 or more after four cycles of treatment.4 Current active systemic opportunistic infection based on clinical assessment.5 Had major surgical procedure and will not havefully recovered from surgical procedure, or has surgical procedure planned during the time the participant is expected to participate in the study.NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate.6 Presence of hepatitis B surface antigen (HBsAg) or IgM anti-HBC at screening or within 3 months prior to first dose of investigational intervention.7 Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention.NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.8 Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.9 History of drug or alcohol abuse according to medical history assessment by investigator within 1 year before screening.10 History of malignancy except disease under study within the past 3 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cured with minimal risk of recurrence.11 Known CNS disease, except for treated asymptomatic CNS metastases.
- •Baseline brain imaging is not required for the eligibility assessment.
- •Leptomeningeal disease is always an exclusion.12 Participant with known history or current symptoms of any of the following clinically significant cardiac conditions.a Unstable angina or myocardial infarction within the past 6 months.b New York Heart Association (NYHA) cardiac disease (Class II or greater) within past 6 monthsc High-risk uncontrolled arrythmias within past 6 months d Clinically significant pericardial disease within past 6 months e Electrocardiographic evidence of acute ischemic or active conduction system abnormalities within past 6 monthsf Any other cardiac illness that could lead to a safety risk to the study participant within past 6 months g Participant with a known left ventricular ejection fraction (LVEF) less than 50% by echocardiogram or multigated acquisition scan (MUGA) within last 28 days before randomization h Study participants with known coronary artery disease, congestive heart failure not meeting the above criteria, must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.13 Received an investigational intervention or used an invasive investigational medical device within 6 months prior to baseline.14 Intended use of prohibited medications within 14 days prior to dosing and during the study.Specific medications listed in Section 6.8 may be allowed.15 Positive Covid-19 RT-PCR test at the time of baseline within 72 hours before hospitalization.
结局指标
主要结局
To characterize the pharmacokinetic profile
时间窗: Following pharmacokinetic parameters will be | evaluated for encapsulated doxorubicin and | unencapsulated doxorubicin: | • Cmax and AUC0-t
and to assess the bioequivalence of TEST(Doxopeg® - liposomal doxorubicin)relative to RLD (Caelyx® - liposomal
时间窗: Following pharmacokinetic parameters will be | evaluated for encapsulated doxorubicin and | unencapsulated doxorubicin: | • Cmax and AUC0-t
doxorubicin) in participants with advanced ovarian cancer or metastatic breast cancer
时间窗: Following pharmacokinetic parameters will be | evaluated for encapsulated doxorubicin and | unencapsulated doxorubicin: | • Cmax and AUC0-t
次要结局
- To further characterize the pharmacokinetic profile of TEST (Doxopeg® - liposomal(doxorubicin) relative to RLD (Caelyx® -liposomal doxorubicin) in participants with advanced ovarian cancer or metastatic breast cancer)
研究者
研究点 (20)
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