CTRI/2016/12/007611已完成未知
A RANDOMIZED, BLINDED, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE, SINGLEDOSE, CROSSOVER, BIOEQUIVALENCE STUDY OF DOXORUBICIN HYDROCHLORIDELIPOSOME INJECTION 2MG/ML (50MG/M2 DOSE) OF SUN PHARMACEUTICAL INDUSTRIES LIMITED AND CAELYX (PEGYLATED LIPOSOMAL DOXORUBICINHYDROCHLORIDE FOR INJECTION) 2 MG/ML (50 MG/M2 DOSE) OF JANSSEN INC., INPATIENTS WITH METASTATIC BREAST CANCER/ADVANCED OVARIAN CARCINOMA,UNDER FED (STANDARDIZED NON HIGH-FAT MEAL) CONDITIO
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •i.Documented diagnosis of metastatic breast cancer, where there is an increased cardiac risk associated with conventional doxorubicin.
- •ii.Documented diagnosis of advanced ovarian carcinoma in women who have failed standard first-line therapy. Platinum-and paclitaxel- based chemotherapy is the current standard first-line treatment regimen.
- •iii.Patients between 18 - 75 years of age (inclusive both).
- •iv.Patients with Performance <= 2 on the ECOG performance scale.
- •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 Ã? 109 /L
- •Hb>= 9.0 g/dL
- •Platelets>= 100 Ã? 109 /L
- •Sr. Creatinine<= 2.0 mg/dL
- •Total Bilirubin<= 1.5 mg/dL or <= 2 mg/dL (for liver mets)
- •AST & ALT<= 2.5 Ã? ULN or <= 5 Ã? ULN (for liver mets)
- •Alkaline phosphatase<= 5 Ã? ULN (unless bone mets are present 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 and pre study laboratory parameters and investigations.
- •viii.Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •ix.Female subjects
- •of child bearing potential practicing an acceptable method of birth control 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; for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same in the six months following discontinuation of Doxorubicin therapy. Subject agrees 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).
- •x.Male subjects
- •practicing an acceptable method of birth control such as sexual abstinence, barrier method of contraception (i.e. condom) for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same in the six months following discontinuation of Doxorubicin therapy. Subject agrees to accept the risk that pregnancy in female partner could still result despite using birth control devices.
排除标准
- •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 HCl Liposome Injection or Dextrose injection.
- •iii.Subjects who have evidence of underlying disease which in the judgment of the investigator would make the subject inappropriate for getting enrolled in the study (except metastatic breast cancer/advanced ovarian cancer).
- •iv.Subjects determined by the study physician/ Investigator to have any medical condition that could jeopardize their health or prejudice the results.
- •v.Use of following drugs as concurrent therapy:
- •(Paclitaxel, Progesterone, Verapamil, Cyclosporine, Dexrazoxane, Cytarabine, Phenobarbital, Streptozocin, cyclophosphamide).
- •vi.Subjects with a history of alcohol, drug or substance abuse in the past 12 months.
- •vii.History of prior Chest radiation, history of myelosuppression, Prior treatment with anthracyclines (doxorubicin, epirubicin, etc.) which may lead to dose adjustment.
- •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.Female subjects who is pregnant, nursing women or likely to become pregnant or have a positive pregnancy test at screening or prior to check in of any study period.
- •xiii.Subjects who have shown positive result in breath alcohol and/or urine drug screening test, prior to any study period.
- •xiv.Abnormal 12 lead ECG, X-ray and 2D-Echocardiography finding.
- •xv.Prior doxorubicin exposure that would result in a total lifetime exposure of >450 mg/m2.
- •xvi.Subject having active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, herpes simplex, P. carinii, candidiasis, mycobacterium avium complex and or other microorganism if under treatment with myelotoxic drugs.
- •xvii.Positive result to HIV, HCV, RPR/VDRL and HBs Ag.
- •xviii.Subjects who have participated in another clinical study for at least 90 days prior to period-I dosing.
- •xix.Blood donation within 90 days prior to period-I dosing.
- •xx.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. or >100/min.
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