A Phase 1, Single-blind, Randomized, Two-way, Crossover Bioequivalence Study of Intravenously Administered ATI 0918 in Patients With Ovarian Cancer That Has Progressed or Recurred After Platinum-based Chemotherapy
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Comparison of AUC in a single dose of ATI0918 vs single dose of Doxil/Caelyx
研究概览
简要总结
The purpose of this study is to find the answers to the following research question(s):
- Is the study drug equivalent to the approved drug, Doxil/Caelyx, and does it act the same way in the body as the approved drug?
ATI-0918 is believed to be a generic of Doxil/Caelyx and this is what the study is trying to prove. All people who participate in this study will receive the research study medication (ATI-0918) and Doxil/Caelyx in addition to best supportive care (treatment for symptoms).
The study drug being tested in this study works the same as the FDA (government) approved drug doxorubicin HCl. ATI-0918 is a generic (the same) formulation of doxorubicin HCl being delivered (given to the patient).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have histologically confirmed ovarian cancer that is potentially sensitive to DOXIL/CAELYX
- •Have disease progression or recurrence after a maximum of 2 prior chemotherapies, one of which was platinum based.
- •Be DOXIL/CAELYX treatment naïve
- •Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of </= 2
- •Have an estimated life expectancy of ≥ 3 months
- •Be >/= 18 and </= 70 years of age
- •Sign a written Institutional Review Board (IRB)-approved informed consent form
- •Have a negative pregnancy test, if patient is of child-bearing potential
- •Have acceptable liver function:
- •Bilirubin </= upper limit of normal (ULN)
- •AST (SGOT), ALT (SGPT) and Alkaline phosphatase </= 1.5 times upper limit of normal
- •Have acceptable renal function:
- •Serum creatinine within normal limits, OR calculated creatinine clearance >/= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- •Have acceptable hematologic status:
- •Neutrophils >/= 1500 cells/mm3
- •Platelet count >/= 100,000 (plt/mm3)
- •Hemoglobin >/= 9 g/dL
- •Have acceptable coagulation status:
- •Prothrombin time (PT) or International Normalized Ratio (INR) within 1.5 × ULN
- •Partial thromboplastin time (PTT) within 1.5 × ULN
- •Agree to use effective contraceptive methods during the study (nonsterile patients of childbearing potential)
排除标准
- •Have New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG) or during Cardiac Stress Testing within 14 days prior to Day 1
- •Have received > 250 mg/m2 of doxorubicin or equivalent as other anthracyclines or similar compounds
- •Have received prior treatment with DOXIL/CAELYX
- •Have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents
- •Have seizure disorders requiring anticonvulsant therapy
- •Have known brain metastases (unless previously treated and well controlled for a period of >/= 3 months)
- •Have severe chronic obstructive pulmonary disease with hypoxemia
- •Have had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
- •Have an active, uncontrolled bacterial, viral, fungal, or other opportunistic infections requiring systemic therapy
- •Are pregnant or nursing. NOTE: Nonsterile women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- •Have received treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
- •Have received radiation therapy to >25% of her total bone marrow during her lifetime
- •Are unwilling or unable to comply with procedures required in this protocol
- •Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- •Have a serious nonmalignant disease (e.g., hydronephrosis, liver failure, significantly impaired hepatic function, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- •Are currently receiving any other investigational agent
- •Have exhibited allergic reactions to doxorubicin or a similar structural compound
研究组 & 干预措施
DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome)
Current Standard of care and/or reference product in Europe (Caelyx) and US (Doxorubicin Hydrochloride (Liposome) and Doxil)
干预措施: DOXIL/CAELYX (Drug)
ATI-0918
Investigational drug arm which will be compared to Doxil/Caelyx and Hydrochloride Doxorubicin (Liposome) arms for bioequivalence analysis
干预措施: ATI-0918 (Drug)
结局指标
主要结局
Comparison of AUC in a single dose of ATI0918 vs single dose of Doxil/Caelyx
时间窗: pre, 30 min + pre, 0, .50, 1, 2, 4, 6, 24, 48, 72, 120, 168, 216 hour post infusion for 2 Cycles (Cycle is defined as 28 days)
The primary objective of this study is to determine the pharmacokinetic equivalence of ATI-0918 and DOXIL/CAELYX as a single dose in patients with ovarian cancer. The outcome measure will be determined by analyzing PK data from drawn from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (Cmax)to determine % variability between ATI0918 and Doxil/Caelyx within each patient.
Comparison of Cmax in a single dose of ATI0918 vs single dose of Doxil/Caelyx
时间窗: pre, 30 min + pre, 0, .50, 1, 2, 4, 6, 24, 48, 72, 120, 168, 216 hour post infusion for 2 Cycles (Cycle is defined as 28 days)
The primary objective of this study is to determine the pharmacokinetic equivalence of ATI-0918 and DOXIL/CAELYX as a single dose in patients with ovarian cancer. The outcome measure will be determined by analyzing PK data from drawn from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (Cmax)to determine % variability between ATI0918 and Doxil/Caelyx within each patient.
次要结局
未报告次要终点