A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, single dose bioequivalence study comparing Temozolomide capsules 250 mg (Manufactured by: Fresenius Kabi Oncology Limited, India) to the reference listed drug TemodalÂ® (Temozolomide) Capsules 250 mg (Manufactured by : SP Europe) in Glioblastoma Multiforme or Anaplastic Astrocytoma patients under fasting condition

Fresenius Kabi Oncology Ltd0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1)Signed written informed consent for participation in the trial.
•2)Male or female patients within 18 to 65 years of age (both inclusive) requiring a dose of 225-275 mg of Temozolomide based on tumor type, BSA (body surface area), cycle number, and toxicity.
•3)Adult patients of newly diagnosed Glioblastoma Multiforme on/eligible for maintenance monotherapy phase with Temozolomide.
•Malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, recurrent or progressive after standard therapy.
•4)Recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
•5)There should a gap of 28 days (4 weeks) between the last day of radiotherapy and the day of randomization.
•6)Patients if already on steroids, then should be on a stable dose of steroids for at least 1 week prior to screening and should be stable throughout the study.
•7)Having a Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2
•8)Patients with a life expectancy of at least three months
•9)Able to comply with study requirement in opinion of Principal Investigator.

•1)Known hypersensitivity to temozolomide, Dacarbazine or any other ingredients of the formulation.
•2)Use of any chemotherapy drugs within 21 days prior to dosing
•3)History of drug/alcohol addiction
•4)History of smoking or tobacco chewing in last 3 months
•5)Known Galactose intolerant, Known deficiency of the Lapp lactase or glucose-galactose malabsorption
•6)A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies.
•7)Patients with known HIV infection.
•8)The receipt of an investigational medicinal product within a period of 30 days prior to the first dose of investigational medicinal Product for the current study.
•9)Any other condition that, in the investigatorâ??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.

发起方

Fresenius Kabi Oncology Ltd