A Randomized, Open Label, Two Treatments, Two Periods, Two Sequences, Single Dose, Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection 2 mg/ml (50mg/m2 dose) of LC-101, Lipocure Ltd (Investigational Product) and Lipodox (Doxorubicin Hydrochloride Liposome Injection), of Sun Pharmaceutical Industries Ltd. (Reference Drug), in patients with Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- To evaluate the safety of subjects participating in the study and to assess the bioequivalence of LC-101 in comparison to LipoDox®, in patients with ovarian cancer.
研究概览
简要总结
This will be a randomized, multi center, open label,two treatments, two periods, two sequences, single dose, crossover,bioequivalence study of Doxorubicin Hydrochloride Liposome injection, 2 mg/mL(50 mg/m2 dose). Subjects will betreated first with a single dose of the RLD (approved liposomal DoxorubicinHydrochloride) or suggested generic formulation. Following 30+2 daysafter first treatment the same subject will be treated with the suggestedgeneric formulation or RLD, respectively.
The study will comprise:
1. Screeningperiod of up to 30 days
2. Firsttreatment with RLD or generic formulation
3. PKBlood sampling through Day 28
4. Secondtreatment with RLD or generic formulation on Day 30+2 days
5. PKBlood sampling through Day 56 and termination visit (28 days post secondtreatment)
A sufficient number of patients with ovariancancer shall be recruited in order to complete the study with at least 24 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Adult female subjects between 18 to 75 years of age at the time of screening visit.
- •2.Availability of subject for the entire study period and willingness to adhere to protocol requirements.
- •3.Patients with documented diagnosis of Ovarian Cancer whose disease has progressed or recurred after platinum-based chemotherapy.
- •4.Subjects eligible for receiving a dose of 50mg/m2 of Doxorubicin liposome (preferably on no other concomitant medication, however, if considered necessary, to be documented and given).
- •5.Patients with Performance ≤ 2 on the ECOG performance scale.
- •6.Subjects whose screening laboratory values are within normal limits or considered by the clinical Investigator/Co-Investigator to be of no clinical significance.
- •7.Signed written informed consent.
排除标准
- •1.History or presence of significant: a.Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride and/or any related compounds etc.
- •b.Clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •c.Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
- •d.Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, p.
- •carinii or other microorganism e.Clinically significant illness (except ovarian cancer)within four (4) weeks before the start of the study f.Positive result to HIV.
- •g.Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study and during the study.
- •2.Subjects who have: h.Systolic blood pressure less than 90 mmHg or more than 160 mmHg i.Diastolic blood pressure less than 60 mmHg or more than 95 mmHg j.Pulse rate below 60/min.
- •or above 100/min 3.Subject under treatment of myelotoxic drugs 4.Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s) 5.Subjects who are legally detained in an official institute.
结局指标
主要结局
To evaluate the safety of subjects participating in the study and to assess the bioequivalence of LC-101 in comparison to LipoDox®, in patients with ovarian cancer.
时间窗: Predose 5 ml each | 0.00 | 0.25 | 0.50 | 0.75 | 1.00 | 1.083 | 1.250 | 1.50 | 2.00 | 4.00 | 6.00 | 9.00 | 25.00 | 49.00 | 97.00 | 169.00 | 241.00 | 337.00 | 504.00 | 672.00
次要结局
- Primary Analytes following 28 Days post treatment(Free doxorubicin)