CTRI/2021/04/032776尚未招募不适用
A Multicentre, Open Label, Balanced, Randomized, Single-Dose, Two-Stage, Two-Treatment, Two-Period, Two-Sequence, Two-Way, Cross-Over Study To Evaluate Comparative Bioavailability Of Temozolomide Powder For Oral Suspension, 300 Mg/15 Ml (Test Drug) With Temodal® Capsules 250 mg (Reference Drug) In Patients Of Malignant Gliomas Under- Going Treatment With Temozolomide Under Fasting Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14
- 试验地点
- 9
- 主要终点
- To characterize the pharmacokinetic profile and to compare bioavailability of test formulation with reference formulation.
研究概览
简要总结
This will be a multicentric, randomized, two-way, crossover study to evaluate comparative bioavailability of Temozolomide in patients of malignant gliomas under-going treatment.
The study will be conducted as a two-stage sequential design applying Potvin et al method C.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or Female patients between 18-70 years of age (Both Inclusive).
- •Patients and/or LAR must be able to understand the investigational nature of this study and to give written informed consent prior to the participation in the trial.
- •Patient with documented evidence of one of the following a.
- •Newly-diagnosed glioblastoma multiforme during monotherapy phase who are already receiving or are about to start receiving temozolomide 250 mg once daily as their calculated individualized dose (e.g. based upon factors such as tumor type, body surface area, cycle number and toxicity).
- •With malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma(anaplastic oligodendrogliomas and anaplastic oligoastrocytomas, and some less common tumours such as anaplastic ependymomas and anaplastic gangliogliomas) showing recurrence or progression after standard therapy and requiring above stated dosing.
- •Body mass index 18 to 30 kg/m2 (both inclusive) with minimum weight being 45 kg
- •Patients with adequate cardiac function defined as left ventricular ejection fraction [LVEF] greater than equal to 50% and no other clinically significant findings on ECHO.
- •Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
- •At least 4 weeks must have elapsed between the last day of radiotherapy and date of randomization
- •Patients with life expectancy of at least 3 months.
- •Able to comply with study requirement in opinion of Investigator.
- •Adequate recovery from recent surgery.
- •At least 1 week must have elapsed from the time of minor surgery; at least 4 weeks must have elapsed from the time of major surgery
- •Male patients must agree to use an effective contraceptive method throughout the study and for 6 month after last dose of Temozolomide.
- •Females of reproductive potential (which include girls who have entered puberty and all women who have a uterus and ovaries and have not completed menopause), must use an acceptable and effective method of avoiding pregnancy, starting from the first dose of study drug until the end of study.
- •Cessation of birth control after this point should be discussed with a 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) -Intrauterine Device (IUD) -Progestin implant (i.e. Implanon or its equivalent) -Progestin injection or progestin oral contraceptive pill plus one 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).
- •In case of postmenopausal females (Menopause is the permanent end of menstruation and fertility), menopause should be clinically confirmed by a patients healthcare provider.
- •Females who have 12 consecutive months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy), need not use the contraceptive measures specified above for females of reproductive potential.
- •The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol.
排除标准
- •Pregnant or breast-feeding female.
- •Known hypersensitivity to Temozolomide, Dacarbazine or any other ingredients of the formulation
- •Patient in need of receiving the study medication via nasogastric tube
- •Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •Active or history of opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.
- •carinii or other microorganism if under treatment with myelotoxic drugs.
- •Patients with severe hepatic impairment (Child pugh class C) or with renal impairment.
- •Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines, cannabinoids and morphine) or history of drug or alcohol addiction
- •Pre-existing motor or sensory neurotoxicity of a severity greater than equal to grade 2 by NCI criteria.
- •Other serious illness or medical condition that would prohibit the understanding and giving of informed consent.
- •Patients tested 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 to the first dose of investigational Product (Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study).
- •Any other condition/Abnormal baseline that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
- •Donation / loss of blood (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine.
- •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 who are smokers or tobacco users in any form.
- •Patients of reproductive potential unwilling to use acceptable contraception (as defined in the protocol inclusion criteria).
结局指标
主要结局
To characterize the pharmacokinetic profile and to compare bioavailability of test formulation with reference formulation.
时间窗: pre-dose (0.0 hour) and at 0.083, 0.167, 0.333, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0 and 12.0 hours.
次要结局
- To evaluate taste/palatability of the sponsor’s test product.(Taste/flavour/mouth feel assessment will be done after 10 seconds)
研究者
研究点 (9)
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