CTRI/2019/03/018338尚未招募不适用
A Multicenter, Open Label, Single-Treatment, Single-Period, Single Dose, Pilot Study to Evaluate the Bioavailability of ZOLADEX (Goserelin Acetate Implant injection BP) 3.6 mg in Pre- and/or Peri-menopausal women with Advanced Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Bioavailability and pharmacokinetic profile of Zoladex 3.6 mg
研究概览
简要总结
Goserelin is asynthetic analogue of naturally occurring gonadotropin-releasing hormone(GnRH). It has potent GnRH-agonist properties during short-term or pulsatiletherapy, but paradoxically it inhibits gonadotropin secretion and suppressesovarian and testicular steroidogenesis during long-term administration byinducing a negative feedback loop within the pituitary gland. Because of theseinhibitory effects, it interferes with the growth of hormone- ependent tumors.The purpose of this study is to obtain the sample size for future work as wellas to inform the PK sampling times. This is a multicenter, open label,single-treatment, single-period, single dose, bioavailability study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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- and/or peri-menopausal female patients age 18 to 50 years of age (both inclusive) with confirmed diagnosis of advanced breast cancer (stage III or stage IV or recurrent metastatic disease) for whom palliative endocrine treatment is indicated and who are eligible to start treatment with goserelin.
- •BMI 18 to 31 kg per meter square (both inclusive), with minimum weight being 45 kg.
- •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 less than
- •Patients with life expectancy of at least 6 months.
- •Able to comply with study requirement in the opinion of the Investigator.
- •Non-smoker defined as non-smoker for at least 6 months (i.e. subject has not smoked or used any tobacco products for the 6 months prior to the screening visit); Patients must test negative on nicotine/cotinine screen at Screening and Check-In.
- •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.
- •Women of child bearing potential (WOCBP) 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 child bearing potential (WOCBP) 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 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: -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) -Barrier method (cervical cap, diaphragm, contraceptive sponge, vaginal spermicide, female condom, or male condom) -Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) -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 pregnant (based on positive pregnancy test at screening or baseline) or breastfeeding.
- •Concurrent malignancy or history of malignancy 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 respiratory, renal, hepatic, hematological, gastrointestinal, endocrine, gynecological, 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 or echocardiogram findings that in the opinion of the Investigator may interfere with trial conduct, patient safety, or interpretation of results.
- •Patients who are already receiving and/or previously received goserelin.
- •Patients receiving anticoagulation medications.
- •Patients with uncontrolled diabetes mellitus (HbA1c greater than 8% as per ADA).
- •Patients with confirmed signs or symptoms related to cerebral metastasis or radiographically-confirmed brain metastasis.
- •Uncontrolled hypertension (systolic blood pressure [BP] greater than 140 or diastolic BP greater than 90mm Hg) or uncontrolled cardiac arrhythmias.
- •(Patients with hypertension controlled by antihypertensive therapies are eligible).
- •Patients with a QTc greater than 450 ms on the ECG at screening or with a personal or family history of long QT syndrome (QTc greater than 450 ms).
- •History of clinically significant cardiovascular disorder or presence of significant risk factor for coronary artery disease
- •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 90 days prior to receiving the first dose of study medicine.
- •Patients who are smokers or tobacco users in any form or who have used tobacco products within the past 6 months.
- •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.
- •History of cerebrovascular accident (CVA) or venous thrombosis.
- •Females of reproductive potential unwilling to use acceptable contraception (as defined in the protocol) throughout the trial and for 12 weeks after the last dose of study medication.
结局指标
主要结局
Bioavailability and pharmacokinetic profile of Zoladex 3.6 mg
时间窗: 0 (Pre-dose), 2, 4, 6, 8, 10, 12, 24, 48 (Day 3), | 120 (Day 6), 192 (Day 9), 288 (Day 13), 312 (Day 14), 336 (Day 15), 360 (Day 16), 384 (Day 17), 432 (Day 19), 480 (Day 21), 528 (Day 23), 576 (Day 25), 624 (Day 27) and 672 (Day 29)
次要结局
- Safety of subjects exposed to the investigational medicinal product(Throught the study)
研究者
研究点 (6)
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