Health Condition 1: null- Progressive or recurrent malignant glioma or advanced metastatic malignant melanoma.
Conditions
Interventions
Intervention1: Temozolomide (CJSC Biocad) Capsules 250 mg: In chemotherapy-naïve patients with progressive or relapsed malignant glioma in the form of glioblastoma multiforme or anaplastic astrocytom
in the second cycle the dose might be increased to 200 mg/m2 once daily provided that absolute neutrophil count is â?¥ 1.5 x 109/L and platelet count is â?¥ 100 Ñ? 109/L at the first day of the next c
Sponsors
Biocad India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. An informed consent signed 2. Documented progressive or recurrent malignant glioma (glioblastoma multiforme or anaplastic astrocytoma) with a relapse or progression after standard therapy or advanced metastatic malignant melanoma 3. 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. 4. 18 to 65 years of age (both inclusive) 5. ECOG 0 to 2 6. Life expectancy is greater than or equal to 12 weeks from the date of the study enrollment 7. 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. 9. Body Mass Index (BMI) is within normal range (18.5 to 24.99 kg per m2). 10. 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. 11. The ability of a patient to comply with the requirements of the protocol according to the Investigatorâ??s opinion. 12. 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. 13. 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. 14. 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.
Exclusion criteria
Exclusion criteria: 1. Aggravated allergological anamnesis (e.g., history of multi-drug allergy, anaphylactic shock etc.) 2. Known hypersensitivity or idiosyncratic reaction to Temozolomide or any other ingredients of the Test drug or the reference drug, as well as to dacarbazine. 3. Confirmed lactose intolerance or other rare hereditary diseases such as saccharose and fructose intolerance, lactase and sucrase- isomaltase deficiency or glucose-galactose malabsorption. 4. Psychiatric disorders and other conditions that might interfere with the ability of a patient to follow the study protocol. 5. History of gastrointestinal surgery (with the exception of appendectomy performed no less than 30 days prior to the screening examination). 6. 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. 7. Inability to insert the venous catheter for blood sampling (e.g., due to a skin disease at the venipuncture sites); 8. 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. 9. 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. 10. 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. 11. Pregnancy and lactation. 12. Smoking more than 10 cigarettes per day. 13. 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. 14. Donation of greater than or equal to 450 mL of blood or plasma within 3 months prior to the study enrollment. 15. Participation in any clinical trials less than 3 months prior to the study enrollment. 16. Simultaneous participation in other clinical trials. 17. Previous participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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-â??), respectively) within 12 hours after single oral administration of the Test drug or the reference drug.Timepoint: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Safety parameters after one dose of one of the investigational drugs during the study â?¢ AEs and SAEs incidence; â?¢ Grade 3-4 CTCAE 4.0 AEs incidence; â?¢ Incidence of treatment discontinuation due to AEs. Timepoint: AEs: recorded from the beginning of the therapy until day 28 after the patientâ??s withdrawal or study termination. SAEs: recorded from the moment of signing informed consent form till end of study | — |
Countries
India
Contacts
Public ContactKavita Mahendra
Biocad India Private Limited
Outcome results
None listed