CTRI/2013/04/003533已完成不适用
Multicenter open-label randomized crossover bioequivalence study of BCD-029 (CJSC Biocad, Russia) and Temodal® (Schering-Plough Labo N.V.) in capsules after single oral administration (under fasting conditions) in patients with progressive or recurrent malignant glioma or advanced metastatic malignant melanoma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Assessment of pharmacokinetic parameters after single administration of the Test drug and the reference drug: Temozolomide maximum plasma concentration , time to maximum plasma concentration , area under concentration-time curve (AUC) from the moment of the drug product administration to Тmax, 12 h and to infinity (AUC(0-tmax), AUC(0-12), AUC(0-∞), respectively) within 12 hours after single oral administration of the Test drug or the reference drug.
研究概览
简要总结
This is an open-label comparative randomized crossover bioequivalence study. Upto 18 patients with progressive or recurrent MG (GBM or AA) and advanced mMM will be recruited into the study. The study will be conducted at 4 sites in India. Primary goal of the study is to study the bioequivalence of BCD-029 (CJSC Biocad, Russia) 250 mg capsule and Temodal® (Schering-Plough Labo N.V., Belgium) 250 mg capsule after single oral administration, under fasting conditions in patients with progressive or recurrent malignant glioma (MG), glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA) and advanced metastatic malignant melanoma (mMM). Secondary goal of the study is to compare safety results obtained for BCD-029 (CJSC Biocad, Russia) 250 mg capsule with those obtained for Temodal® (Schering-Plough Labo N.V., Belgium) 250 mg capsule after single oral administration , under fasting conditions in patients with progressive or recurrent MG (GBM or AA) and advanced mMM. xml:namespace prefix = "o" ns = "urn:schemas-microsoft-com:office:office" /
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •An informed consent signed
- •Documented progressive or recurrent malignant glioma (glioblastoma multiforme or anaplastic astrocytoma) with a relapse or progression after standard therapy or advanced metastatic malignant melanoma
- •The period from the date of the last chemotherapeutic drug administration (if applicable) to the date of the first planned study drug (Temozolomide) administration within the clinical study is no less than 23 days.
- •18 to 65 years of age (both inclusive)
- •ECOG 0 to 2
- •Life expectancy is greater than or equal to 12 weeks from the date of the study enrollment
- •Negative test results for hepatitis B, C, HIV and syphilis dated no more than 6 weeks before the screening examination.
- •8.Pre specified laboratory values hemoglobin greater than or equal to 100 g per L, ANC greater than or equal to 1.5 Ñ… 109 per L, platelet count greater than or equal to 100 Ñ… 109 per L, hepatic enzymes level (AST, ALT, ALP, GGT) less than or equal to 2.5 x ULN (less than or equal to 5 x ULN is acceptable if liver metastases are present), total plasma bilirubin and plasma creatinine are greater than or equal to ULN.
- •Body Mass Index (BMI) is within normal range (18.5 to 24.99 kg per m2).
- •Hemodynamic parameters are within normal range: SBP is within 100 to 130 mm Hg, DBP is within 60 to 90 mm Hg, Heart Rate is within 50 to 90 bpm.
- •The ability of a patient to comply with the requirements of the protocol according to the Investigator’s opinion.
- •Male and female patients with normal reproductive function and their sexual partners are aware and willing to use voluntarily reliable methods of contraception from 4 weeks before the enrollment to the study and up to 6 months after the administration of the last dose of the study drug products.
- •This requirement does not apply to patients who underwent operative sterilization or those defined as post-menopausal (documentally confirmed) within last 2 years.
- •Reliable methods of contraception suggest using 1 barrier method in combination with 1 of the following methods spermicides intra-uterine device.
- •Willingness not to drink alcohol within 24 hours prior to the first dosing of Test drug or reference drug and within 48 hours after the last dosing.
- •Willingness not to drink grapefruit juice or grapefruit-containing foods within 72 hours prior to the first dosing of Test drug or reference drug and within 72 hours after the last dosing.
排除标准
- •Aggravated allergological anamnesis (e.g., history of multi-drug allergy, anaphylactic shock etc.)
- •Known hypersensitivity or idiosyncratic reaction to Temozolomide or any other ingredients of the Test drug or the reference drug, as well as to dacarbazine.
- •Confirmed lactose intolerance or other rare hereditary diseases such as saccharose and fructose intolerance, lactase and sucrase- isomaltase deficiency or glucose-galactose malabsorption.
- •Psychiatric disorders and other conditions that might interfere with the ability of a patient to follow the study protocol.
- •History of gastrointestinal surgery (with the exception of appendectomy performed no less than 30 days prior to the screening examination).
- •Any acute or chronic infection at the time of screening examination; acute infection of bacterial, virus, or mycotic origin less than 4 weeks prior to the study initiation.
- •Inability to insert the venous catheter for blood sampling (e.g., due to a skin disease at the venipuncture sites);
- •Any diseases or other conditions that might influence the pharmacokinetics of the Test drug/the reference drug, for example:.
- •intestinal malabsorption;.
- •severe hepatic or renal dysfunction (hepatic enzymes level (AST, ALT, ALP, GGT) greater than 2.5 x ULN (greater than 5 x ULN if liver metastases are present), total blood bilirubin and plasma creatinine greater than ULN;.
- •cardiovascular disorders (severe refractory idiopathic hypertension, decompensated cardiac disorders (III-IV class CHF according to NYHA);.
- •decompensated respiratory insufficiency, tumor infiltration of lungs;.
- •neuroendocrine disorders (e.g., severe refractory diabetes mellitus);.
- •autoimmune disorders;.
- •epileptic seizures.
- •A history of any other neoplasm with the exception of adequately treated basal-cell carcinoma or cervical carcinoma in situ and cases with the remission period of no less than 5 years.
- •The use of medicines (including non-prescription) and dietary supplements, which have pronounced influence on hemodynamics, liver function etc. (barbiturates, omeprazole, cimetidine etc.), less than 30 days prior to the study initiation. Conditions requiring the constant use of systemic corticosteroids. Received blood less than 2 weeks prior to the beginning of the screening examination.
- •Pregnancy and lactation.
- •Smoking more than 10 cigarettes per day.
- •Consumption of more than 10 units of alcohol per week (1 unit is equivalent to 0.5 L of beer, 200 mL of wine or 50 mL of pure alcohol) or a history of alcoholism, narcomania or drug abusing.
- •Donation of greater than or equal to 450 mL of blood or plasma within 3 months prior to the study enrollment.
- •Participation in any clinical trials less than 3 months prior to the study enrollment.
- •Simultaneous participation in other clinical trials.
- •Previous participation in this study.
结局指标
主要结局
Assessment of pharmacokinetic parameters after single administration of the Test drug and the reference drug: Temozolomide maximum plasma concentration , time to maximum plasma concentration , area under concentration-time curve (AUC) from the moment of the drug product administration to Тmax, 12 h and to infinity (AUC(0-tmax), AUC(0-12), AUC(0-∞), respectively) within 12 hours after single oral administration of the Test drug or the reference drug.
时间窗: 10 min, 20 min, 30 min, 45 min, 1hr, 1hr 20 min, 1hr 40 min, 2 hrs, 2 hrs 30 min, 3hrs, 4hrs, 6hrs, 8hrs, and 12 hours after the test or reference administration
次要结局
- Assessment of Safety parameters after one dose of one of the investigational drugs during the study(• AEs and SAEs incidence;)
研究者
研究点 (4)
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