CTRI/2015/02/005542已完成不适用
A RANDOMIZED, OPEN LABEL, TWO TREATMENT, THREE PERIOD, THREE SEQUENCE, SINGLE DOSE, REPLICATED CROSSOVER, BIOEQUIVALENCE STUDY OF DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION 2MG/ML (50MG/M2 DOSE) OF SUN PHARMACEUTICAL INDUSTRIES LIMITED AND CAELYX (DOXORUBICIN HYDROCHLORIDE) LIPOSOME INJECTION 2 MG/ML (50 MG/M2 DOSE) OF JANSSEN-CILAG INTERNATIONAL NV, IN PATIENTS WITH METASTATIC BREAST CANCER/ADVANCED OVARIAN CANCER, UNDER FED (STANDARDIZED NON HIGH-FAT MEAL) CONDITIONS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 10
- 主要终点
- •To assess the bioequivalence between Test product (A) and Reference product (B) in metastatic breast cancer/advanced ovarian cancer patients under fed (Standardized non high-fat meal) conditions by means of AUC0-t, Cmax and AUC0-∞
研究概览
简要总结
This study is Randomized, Open label, multi center, two treatment, three period, threesequence, single dose, replicated crossover study, to assessthe safety of Test product (A) and Reference product (B) and to assess the bioequivalence between Test product DoxorubicinHydrochloride Liposome Injection 2 mg/mL (50 mg/m2 dose) of SunPharmaceutical Industries Ltd. and Caelyx(Doxorubicin Hydrochloride) LiposomeInjection 2 mg/ml (50 mg/m2 dose) of Janssen-Cilag International NV in metastatic breast cancer/advancedovarian cancer patients , under fed (Standardized non high-fat meal)conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •i.Documented diagnosis of metastatic breast cancer (preferably on no other concomitant medication, however, if considered necessary, to be documented and given). ii.Documented diagnosis of advanced ovarian cancer in patients who have failed a first-line platinum-based chemotherapy regimen (preferably on no other concomitant medication, however, if considered necessary, to be documented and given). iii.Patients between
- •75 years of age (inclusive both). iv.Patients with Performance ï‚£ 2 on the ECOG performance scale (listed in Appendix III). v.Patients whose organ and Immune system function are adequate as indicated by the following laboratory values or considered by the Investigator/sub-Investigator to be of no clinical significance. SystemLab value Hematologic ANC≥ 1.5 × 109 /L Hb≥ 9.0 g/dL Platelets≥ 100 × 109 /L Renal Sr. Creatinine≤ 2.0 mg/dL Hepatic Total Bilirubin≤ 1.5 mg/dL or ≤ 2 mg/dL (for liver mets) AST & ALT≤ 2.5 × ULN or ≤ 5 × ULN (for liver mets) Alkaline phosphatase≤ 5 × ULN (unless bone mets are p esent in the absense of liver mets) vi.Subject willing to give written consent according to section 15.3 of the protocol. vii.Subjects must have clinically acceptable results for all the screening parameters. viii.Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. ix.Subjects •of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as sexual abstinence, birth control pills (if taken for at least 3 months prior to receiving the study medication), progestin injection or implants, condom plus spermicide, diaphragm plus spermicide, IUD, or vaginal spermicidal suppository. You agree to accept the risk that pregnancy could still result despite using birth control devices. OR •Postmenopausal for at least past 12 months. OR •Surgically sterile (bilateral tubal ligation / bilateral oophorectomy / hysterectomy has been performed on the subject).
排除标准
- •Subject who meets any of the exclusion criteria shall not be enrolled for this study: i.Subject with a history of clinically significant gastrointestinal, dermatological, cardiovascular, renal, psychiatric, cerebrovascular, neurological, hepatic, pulmonary, or endocrine disease in the last 12 months.
- •ii.Allergy or Significant history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of Doxorubicin Liposomal injection.
- •iii.Subjects who have no evidence of underlying disease which in the judgment of the investigator would not make the subject inappropriate for getting enrolled in the study (except metastatic breast cancer/advanced ovarian cancer) during screening medical history and whose physical examination are performed within 21 days prior to commencement of the study.
- •iv.Subjects determined by the study physician to have any medical condition that could jeopardize their health or prejudice the results.
- •v.Subjects with any clinically significant illness (except metastatic breast cancer/advanced ovarian cancer) within 4 weeks before the start of the study.
- •vi.Use of following drugs as concurrent therapy: (Paclitaxel, Progesterone, Verapamil, Cyclosporine, Dexrazoxane, Cytarabine, Phenobarbital, Streptozocin).
- •vii.Subjects with a history of alcohol, drug or substance abuse in the past 12 months.
- •viii.Subjects who have used enzyme inducing or inhibiting drugs (like Phenytoin, Carbamazepine, Barbiturates, Griseofulvin etc.) within 30 days of Period 1 dosing.
- •ix.Subjects deemed uncooperative or noncompliant.
- •x.Subject who smokes or chew tobacco product.
- •xi.Difficulty in coming up for follow up xii.Subject who is pregnant, lactating or likely to become pregnant or have a positive pregnancy test at screening or prior to check in of any of the three periods.
- •xiii.Abnormal 12 lead ECG, X-ray and 2D-Echocardiography finding.
- •xiv.Prior doxorubicin exposure that would result in a total lifetime exposure of >450 mg/m2 after four cycles of treatment.
- •xv.Subject having active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, herpes simplex, P.
- •xvi.Positive result to HIV, HCV, RPR and HBsAg. xvii.Subjects who have participated in another clinical study for at least 90 days prior to first dosing xviii.Blood donation within 90 days prior to first dosing.
- •xix.Subjects who have: -Systolic blood pressure <90 mm of Hg or >140 mm of Hg -Diastolic blood pressure <60 mm of Hg or >90 mm of Hg -Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the investigator.
- •Radial pulse rate <60/min.
结局指标
主要结局
•To assess the bioequivalence between Test product (A) and Reference product (B) in metastatic breast cancer/advanced ovarian cancer patients under fed (Standardized non high-fat meal) conditions by means of AUC0-t, Cmax and AUC0-∞
时间窗: In each of the three study periods, 18 blood samples will be collected. A pre-dose blood sample of 10 mL will be collected within 1 hour prior to schedule dosing (before start of intravenous Infusion). Post-dose blood samples (4 mL each) will be collected at 0.250, 0.500, 0.750, 1.000, 1.083, 1.250, 1.500, 2.000, 4.000, 6.000, 9.000, 25.000, 49.000, 97.000, 169.000, 241.000 and 337.000 after start of intravenous Infusion.
次要结局
- To assess the safety of test product (A) and Reference Product (B) in metastatic breast cancer/advanced ovarian cancer patients(In each of the three study periods, 18 blood samples will be collected. A pre-dose blood sample of 10 mL will be collected within 1 hour prior to schedule dosing (before start of intravenous Infusion). Post-dose blood samples (4 mL each) will be collected at 0.250, 0.500, 0.750, 1.000, 1.083, 1.250, 1.500, 2.000, 4.000, 6.000, 9.000, 25.000, 49.000, 97.000, 169.000, 241.000 and 337.000 after start of intravenous Infusion.)
研究者
研究点 (10)
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