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Bioequivalence of Temozolomide capsules to Chinese cancer patients in an open-label, randomised, single-dose, fasting, two-way crossover study

Bioequivalence of Temozolomide capsules to Chinese variant astrocytoma and primary-care polymorphism among patients with glioblastoma in an open-label, randomised, single-dose, fasting, two-way crossover study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006282
Enrollment
Unknown
Registered
2015-03-23
Start date
2015-04-28
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

Interventions

Sponsors

Beijing Shijitan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years (including 18 and 65 years old), male and female subjects; 2. Weight 50 kg, or body mass index (BMI) generally within the scope of the 18-26, including boundary value, body mass index (BMI) = weight (kg)/height (m) 2, the surface area of 1.30-1.30 m2; 3. The imaging and pathological diagnosis of pleomorphic variant astrocytoma patients or already between patients with glioblastoma; 4. Expected lifetime is more than three months; 5. Have to have surgery or not surgery (or reject) selecting patients with chemotherapy 6. No serious heart disease, ultrasonic electrocardiogram (ecg) to evaluate the left ventricular ejection fraction >45%, no serious arrhythmia, uncontrolled hypertension without drugs, without serious liver and kidney disorders; 7. Have plenty of bone marrow hematopoietic function, absolute neutrophil count acuity 1.5* 10^9/L, the platelet count 100*10^9/L, or hemoglobin >90 g/L; 8. Karnofsky functional status score (KPS score) >=60 points; 9. From previous cytotoxic drugs chemotherapy to interval >=4 weeks, it is not merged steroid hormone treatment; 10. There is no known history of allergies to drugs and biological agents, there is no history of drug abuse; 11. to take effective contraceptive measures within six months, there is no family planning; 12. Experiment former have detailed understanding of nature, significance, may benefit, might inconvenience and potential danger, and voluntary participation in the clinical trials, understand the research procedure and signed a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Are the central nervous system, cardiovascular system, liver and kidney function is not complete, blood system, or any other that may affect the results of the study of diseases and physiological conditions; 2. Pregnancy or breast-feeding women, did not take effective contraceptive measures, the subjects or their spouses have fertility planners within six months; 3. Allergic to nitroso urea class alkylating agent; 4. has a history of allergies to other drugs and biological agents, or other allergies; 5. Major depression, bipolar disorder and schizophrenia patients with mental disorders, a potential suicide attempt or mental mood disorder patients; 6. In active have serious systemic diseases and infectious diseases; 7. Has been combined with serious heart, liver, kidney and hematopoietic system, severe primary disease; 8. drugs cannot control patients with grand mal; 9. Unable to swallow or always accept the urea nitrate class alkylating agent patients with severe vomiting; 10. As subjects in drug clinical trials within three months, or three months had blood donors, or within 4 weeks before test had a transfusion; 11. Known HIV, HBV, HCV infected with the virus and treponema pallidum; 12. researchers think that has any unfavorable factors to participate in the test of volunteers.

Design outcomes

Primary

MeasureTime frame
Pulse;Respiration;Blood Pressure;Temperature;ECG;

Countries

China

Contacts

Public ContactXinghe Wang
wangxinghe@yahoo.com+86 010-63926401

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026