Health Condition 1: C719- Malignant neoplasm of brain, unspecified
Conditions
Interventions
Intervention1: Temozolomide Capsules 250 mg: The recommended therapeutic dosing regime of Temozolomide capsules is 5 consecutive days of therapy for 28-days treatment cycle for the initial chemotherap
Sponsors
Fresenius Kabi Oncology Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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. (or) 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the pharmacokinetic profile of the sponsorâ??s test formulation (temozolomide 250 mg capsules) relative to that of reference formulation (TEMODAL 250 mg capsules) in adult, male and/or female patients under fasting conditions and to assess the bioequivalenceTimepoint: The venous blood samples will be withdrawn Pre-dose and 0.16 (10 min), 0.25 (15 min), 0.33 (20 min) 0.50 (30 min), 0.75 (45 min), 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each period administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patients exposed to the Investigational Medicinal ProductTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Praveen Shetty
Lambda Therapeutic Research Ltd.
Outcome results
None listed