CTRI/2020/02/023101尚未招募3 期
A phase III, two arm, multicentric, randomized, open label, parallel, multiple dose pharmacodynamics study of Goserelin 3.6 mg Injection (Eurofarma Laboratorios S. A.) administered subcutaneously in comparison with the reference drug ZOLADEX® 3.6 mg Injection (AstraZeneca) administered subcutaneously in premenopausal patients with advanced Breast cancer.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 17
- 主要终点
- Evaluation and comparision of the pharmacodynamics of test product against
研究概览
简要总结
The current study is being conducted to evaluate the pharmacodynamics effect of test product (injection goserelin 3.6mg implant) against that of reference product and establish non-inferiority of test product as compared to reference product. Goserelin acetate is a synthetic analogue of gonadotropin-releasing hormone (GnRH). When given acutely, it transiently increases the plasma levels of luteinising hormone (LH) and follicle-stimulating hormone (FSH). This is a phase III, two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with advanced breast cancer This study is designed to establish pharmacodynamic comparability between the two products that can be maintained for the rest of the active treatment phase (once it has been achieved) rather than establishing pharmacokinetic comparability. 68 patients patients will be enrolled into the study. Attempt will be made to enrol equal number of patients in each treatment arm. Total duration of the study will be around 99 days (including 14 days of screening). The study will commence only after a written approval is obtained from the Institutional Ethics Committee and applicable regulatory authorities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pre-menopausal female patients of 18 to 50 years of age (both inclusive).
- •BMI 18.5 to 30 kg/m2 (both inclusive).
- •Patient with a confirmed diagnosis of advanced breast cancer (TNM stage III or stage IV or recurrent metastatic disease) who are scheduled to start goserelin therapy as per Investigator discretion.
- •Hormone sensitivity (ER positive) of primary or secondary tumour tissue
- •Patients with baseline estradiol levels >30 pg/mL
- •Patients must be able to understand the investigational nature of this study and to give written informed consent prior to the participation in the trial.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Patients with life expectancy of at least 3 months as judged by the Investigator.
- •Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
- •Patient should be able to comply with study requirement in the opinion of Investigator.
- •Patients must not have taken any anti-androgens, estrogen, antiestrogen, selective estrogen receptor modulators, aromatase inhibitors or hormonal forms of contraception within past one month of screening.
- •Patient may have had recent use of oral contraceptive pills but these must be discontinued 30 days prior to dosing.
- •Adequate hematologic status, renal and liver function.
- •Women of childbearing potential must not be pregnant or breastfeeding (as documented by a negative serum pregnancy test at screening and negative urine pregnancy test at baseline).
- •Women of childbearing potential or her partner must use an acceptable and effective non-hormonal method of avoiding pregnancy, starting at least four weeks before the study drug administration and up to 12 weeks after the after the last dose of study drug administration.
- •Cessation of birth control after this point should be discussed with the responsible physician.
- •For this study, acceptable and effective methods of contraception include: a) 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) b) Barrier method (cervical cap, diaphragm, contraceptive sponge, vaginal spermicide, female condom, or male condom) c) Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) d) Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner).
- •If the patient becomes sexually active during the study, then she is required to use a double barrier method of contraception.
排除标准
- •Patients who are not able to provide written informed consent.
- •Patients who are menopausal.
- •Patients who are scheduled to receive any chemotherapy/radiotherapy in addition to goserelin.
- •Patients who are already on GnRH receptor agonist or antagonist therapy.
- •Patients who have previously failed on GnRH receptor agonist or antagonist therapy.
- •Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree (proven or suspected) of brain or leptomeningeal involvement (past or present) or symptomatic pulmonary lymphangitic spread.
- •Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not compromised as a result of the disease.
- •Patients who are intended to be started on any medication apart from study drug that can have impact on any of the study endpoints.
- •Patients who are pregnant or breastfeeding.
- •Concurrent malignancy or history of malignancy (apart from disease condition under study) within last 5 years before screening except curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin
- •Patients with a clinically significant medical condition other than advanced breast cancer including but not limited to renal, hepatic, gastrointestinal, endocrine, cardiovascular, neurological or psychiatric disease, alcohol or substance abuse, or any other condition that may affect the patient health or the outcome of the trial as judged by the investigator.
- •Presence of clinically significant physical exam, laboratory, medical history, ECG/echocardiogram findings that in the opinion of the Investigator may interfere with trial conduct, patient safety, or interpretation of results.
- •Patients with a known hypersensitivity to GnRH, GnRH-agonist analogues or any of the components in IMP.
- •Patients receiving anticoagulation medications.
- •Patients with uncontrolled diabetes mellitus (HbA1c > 8 % as per ADA) at randomization (those who have controlled blood sugar (fasting) will be eligible for randomization)
- •Patients with confirmed signs or symptoms related to cerebral metastasis or radiographically confirmed brain metastasis.
- •Uncontrolled hypertension (systolic blood pressure [BP] >140 or diastolic BP >90mm Hg) or uncontrolled cardiac arrhythmias.
- •(Patients with hypertension controlled by antihypertensive therapies are eligible).
- •Patients with a QTc>450ms on the ECG at screening.
- •History of clinically significant cardiovascular disorder
- •Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines, cannabinoids and morphine) or history of drug or alcohol abuse within the past 1 year, as judged by the Investigator, or a positive result on the urine drug/alcohol screen which is not consistent with current medical treatment.
- •Concomitant use of medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics.
- •A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies.
- •Patients who test positive for HIV and/or syphilis.
- •The receipt of an investigational product, or participation in a drug research study within a period of 30 days prior screening or 5 half-lives within the last dose of investigational product, whichever is longer.
- •Current use of any drugs that are known to interfere with goserelin metabolism or to cause a drug-drug interaction.
- •Donation / loss of blood/plasma or blood product (without replenishment) (1 unit or 350 mL) within 180 days prior to receiving the first dose of study medicine.
- •Patients with a mental incapacity, unwillingness, or language barrier that precludes the ability to understand or cooperate with study procedures.
- •Presence of clinically significant findings on the physical exam, laboratory testing, medical history, ECG that in the opinion of the Investigator may interfere with trial conduct, patient safety, or interpretation of results.
- •Any contraindications for goserelin administration.
- •Females of reproductive potential unwilling to use acceptable contraception (as defined in the protocol) starting at least four weeks before the study drug administration and up to 12 weeks after the after the last dose of study drug administration.
结局指标
主要结局
Evaluation and comparision of the pharmacodynamics of test product against
时间窗: For pharmacodynamics | Serum Estradiol: | Day 1, Day 2, Day 8, Day15, Day 22, Day 29, Day-36, | Day 43, Day 50, Day 57, | Day 64, Day 7), Day 78 and Day 85 | Serum LH: | Day 1, Day 2, Day15, Day 29, Day 43, Day 57, Day 71 and Day 85 | Serum FSH: | Day 1, Day 29, Day 57 and Day 85
reference product and establish non-inferiority.
时间窗: For pharmacodynamics | Serum Estradiol: | Day 1, Day 2, Day 8, Day15, Day 22, Day 29, Day-36, | Day 43, Day 50, Day 57, | Day 64, Day 7), Day 78 and Day 85 | Serum LH: | Day 1, Day 2, Day15, Day 29, Day 43, Day 57, Day 71 and Day 85 | Serum FSH: | Day 1, Day 29, Day 57 and Day 85
次要结局
- Evaluation of the pharmacokinetic and safety of the test product as compared to reference product.(For pharmacokinetic)
研究者
研究点 (17)
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