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临床试验/CTRI/2018/06/014575
CTRI/2018/06/014575已完成1 期

A MULTICENTER, OPEN LABEL, RANDOMIZED, BALANCED,TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, SINGLE DOSE, TWO-WAYCROSSOVER, BIOEQUIVALENCE STUDY OF DOXORUBICINHYDROCHLORIDE LIPOSOME CONCENTRATE FOR SOLUTION FORINFUSION 2 mg/mL AT A DOSE OF 50mg/m2 OF EMCURE PHARMACEUTICALSLTD. INDIA, WITH CAELYX 2mg/mL CONCENTRATE FOR SOLUTION FORINFUSION (EACH mL CONTAINING 2 mg DOXORUBICIN HYDROCHLORIDE INA PEGYLATED LIPOSOMAL FORMULATION) AT A DOSE OF 50mg/m2 OFJANSSEN-CILAG INTERNATIONAL NV BELGIUM, IN FEMALE PATIENTS WITHADVANCED OVARIAN CANCER WHO HAVE FAILED A FIRST-LINEPLATINUM-BASED CHEMOTHERAPY REGIMEN AND WHO ARE ALREADYRECEIVING OR SCHEDULED TO START THERAPY WITH THE DOXORUBICINHYDROCHLORIDE LIPOSOME INJECTION UNDER FASTING CONDITIONS.

Emcure Pharmaceuticals Ltd0 个研究点目标入组 67 人开始时间: 待定最近更新:
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试验速览

阶段
1 期
状态
已完成
入组人数
67
研究概览入排标准研究者记录与标识符相似试验

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

  • •1. Female patients, 18 to 75 years of age (both inclusive) and having a Body Mass
  • •Index (BMI) at least 17 kg/m2.
  • •2. Have histologically or cytologically confirmed advanced ovarian cancer
  • •3. Patients with advanced ovarian cancer who have failed a first-line platinum-based
  • •chemotherapy regime and who are already receiving or scheduled to start
  • •Doxorubicin Hydrochloride liposomal injection 50 mg/m2 dose as monotherapy as
  • •per Investigator judgment.
  • •4. Patients with life expectancy for at least 3 months.
  • •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (The
  • •woman should be ambulatory, capable of all self-care, up for more than 50% of
  • •waking hours. She may or may not be able to carry out any work activities).
  • •6. Patients should preferably be on monotherapy. However, cancer patients receiving
  • •concomitant medications are allowed to participate provided:
  • •The concomitant medication and their dosing regimen are expected to be same for
  • •both the study periods.
  • •The concomitant medications do not interfere with the study drug (If concomitant
  • •medication is required during the study period, the patients will be treated
  • •accordingly, and a decision to continue or discontinue the patients will be made
  • •by the investigator).
  • •7. Availability of patient for the entire study period and willingness to adhere to
  • •Protocol requirements as evidenced by the written ICF duly signed by the patient.
  • •8. Either the female is of non-child bearing potential (females having documented
  • •history of surgical sterilization or are postmenopausal (12 months of amenorrhea
  • •after the last menstrual period) or if the female is of child bearing potential, then she
  • •is eligible if:
  • •Patient has used an effective method of contraception or abstinence from at least 4
  • •weeks prior to study drug administration. Effective method includes:
  • •Tubal sterilization (tubal ligation performed more than one month before Study
  • •Day 1; transcervical tubal occlusion procedure performed more than six months
  • •before Study Day 1)
  • •Intrauterine Device (IUD)
  • •Progestin Implant (i.e. Implanon or its equivalent)
  • •Progestin injection or progestin oral contraceptive pill + one barrier method
  • •(cervical cap, diaphragm, contraceptive sponge or vaginal spermicide + a male or
  • •female condom)
  • •Two barrier methods used together (cervical cap, diaphragm, contraceptive
  • •sponge or vaginal spermicide + a male or female condom)
  • •Absolute sexual abstinence (no sexual intercourse or genital contact with a male
  • •Patient is willing to avoid pregnancies during the study and up to 06 months after
  • •the last dose of study drug by use of an effective method of permitted
  • •contraception or abstinence.
  • •Patients having negative pregnancy test.

排除标准

  • •Patients will be excluded from the study, if they meet any of the following criteria:
  • •1. Patients who have a history of hypersensitivity or idiosyncratic reactions to a conventional or novel liposomal formulation of Doxorubicin HCl and its
  • •excipients.
  • •2. Prior Doxorubicin (or other anthracyclines) exposure that would result in a total
  • •lifetime exposure of 550 mg/m2 or more after four cycles of treatment.
  • •3. Patients who require any dose modifications (Dose other than 50 mg/m2)
  • •4. Have received treatment with radiation therapy, chemotherapy, immunotherapy in
  • •less than 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C)
  • •5. If any patient whose weight changes during the study requiring a ± 5% dose
  • •adjustment will be discontinued from the study and excluded from the analysis.
  • •6. If any signs or symptoms of extravasation have occurred, the infusion should be
  • •immediately terminated and the patient will be discontinued from the study and
  • •excluded from the analysis.
  • •7. Known active brain metastasis including leptomeningeal involvement (patients
  • •with brain metastases can only be enrolled if they are treated and stable for >8
  • •weeks and who currently do not require steroid or radiation therapy)
  • •8. Clinically significant Pre-existing toxicity by National Cancer Institute (NCI)
  • •Common Terminology Criteria for Adverse Events (CTCAE) criteria. Mild to
  • •moderate Pre-existing toxicity can be allowed only if in the opinion of
  • •investigator, it will not require dose modification, will not interfere with the study
  • •assessment and will not pose undue safety concerns to the patient. (â??Palmarâ??
  • •plantar erythrodysesthesiaâ?? and â??Stomatitisâ?? of grade 2 and above requires dose
  • •modification, hence not allowed).
  • •9. Patients with significantly impaired hepatic or renal function.
  • •10. Significant history or current evidence of chronic - infectious,
  • •cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic
  • •(endocrine), hematological, gastrointestinal, immunological or psychiatric
  • •diseases, or organ dysfunction.
  • •11. Laboratory parameters:
  • •Patients with ANC < 1500/mm3
  • •Platelet count < 100,000/mm3
  • •Hemoglobin < 9.0 g/dl
  • •Bilirubin >2.5 x ULN or if any dose modification required due to abnormal
  • •bilirubin levels
  • •Alkaline phosphatase, ALT, AST > 2.5 x ULN
  • •For other laboratory parameters, the patient can be included if the values are
  • •clinically non-significant in the opinion of investigator.
  • •12. Patients with any of the following cardiac conditions:
  • •Left ventricular ejection fraction (LVEF) <50 % as determined by ECHO
  • •Clinically significant QTc prolongation, Uncontrolled arrhythmias, Acute
  • •Ischemia, or other significant abnormalities as determined by ECG.
  • •Prior history of Unstable angina in past 06 months.
  • •Prior history of Myocardial infarction within the past 06 months.
  • •New York State Heart Association (NYHA) class II-IV heart failure.
  • •Any other cardiac illness that could lead to a safety risk to the patient in case
  • •of enrolment in the study.
  • •13. Pregnant or lactating woman.
  • •14. Females of childbearing potential unwilling to use acceptable contraception (as
  • •identified in the protocol)

研究者

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