advanced Glioma
Conditions
Interventions
experimental:ACT001
Sponsors
Tianjin Medical University Cancer Institute & Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically glioblastoma, which belongs to any of diffuse astrocytoma, oligodendroglioma, other astrocytoma, ependymoma, other gliomas, choroid plexus neoplasms, neurons and mixed neurons – glioma (referring to The 2016 World Health Organization Classification of Tumors of the Central Nervous System); 2. Recurrent advanced glioblastoma with no standard treatment options; 3. Measurable disease by Response Assessment in Neuro-Oncology (RANO) criteria using gadolinium-enhanced MRI scanning; 4. No abnormal bleeding with INR=2; 5. Male or female and at least 18 years of age. 6. Adequate organ function (ANC = 1.5×10^9/L; platelets = 100×10^9/L, Hb = 10 g/dl; total bilirubin = 1.5×institutional upper limit of normal (ULN); ALT and AST = 2.5×ULN (= 5.0×ULN if liver metastasis); plasma creatinine = 1.5× ULNQTc < 450 ms (male), <470 ms (female); 7. A life expectancy of at least 12 weeks; 8. BMI 19 to 28; 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 10. Female subjects are eligible if they are: Non-childbearing potential, defined as Previous hysterectomy or bilateral oophorectomy, Previous bilateral tubal ligation, Post-menopausal (total cessation of menses for = 1 year); Childbearing potential with a negative serum pregnancy test at screening (within 7 days of the first investigational product administration), and uses adequate contraception (eg. intrauterine device, contraceptive and condom) before study entry and throughout the study until 30 days after the last investigational product administration; 11. Male patients, if sexually active, must agree to use a highly-effective method of contraception with their female partners or completely ascetic; 12. Provided written informed consent prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. The subject has uncontrolled infection; 2. The subject has serious diseases such as unstable angina pectoris, myocardial infarction, heart failure (New York Heart Association class > II) or stroke within 6 months prior to the enrollment; 3. A gastrointestinal absorption disorder that would limit the bioavailability of an oral medication or cannot take oral drugs; 4. The subject has epilepsy and/or high intracranial pressure that can not be controlled by medication, eg. mannitol>500ml, dexamethasone>15mg, methylprednisolone >80mg or its equivalent; 5. Pre-existing allergy to ACT001, its similar compounds or related compounds; 6. Treatment with other cancer therapies such as chemotherapy, biological or targeted therapy, immunotherapy or radiation therapy either currently or within 4 weeks of ACT001 dosing (6 weeks for BCNU, CCNU or mitomycin-C); 7. Subjects with uncontrolled high blood pressures (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg); 8. Subject who has not recovered to CTCAE Grade 1 (referring to CTC AE version 4.03) or better from the adverse events due to prior anti-cancer therapies prior to the first dose of study therapy. Grade 2 alopecia, alkaline phosphatase increase and glutamyltranspeptidase are allowed to enter. Subject with stable adverse events can also be allowed to enter if both the investigator and sponsor reach an agreement; 9. Major surgery within 4 weeks of commencing first study therapy; 10. Pregnant or breast-feeding females; 11. Subject with infection with HIV or active hepatitis B (both HBsAg and HBV-DNA positive) or C viruses (HCV antibody positive); 12. The subject has participated in other drug clinical trials < 4 weeks prior to obtaining the informed consent; 13. Subject has a history of mental disorders; 14. The subject is, in the opinion of the investigator, unsuitable for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;dose limited toxicity;pharmacokinetics parameters, eg. Cmax, Tmax and AUC, etc; | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy, including disease control rate, Objective response rate, progression free survival; | — |
Countries
China
Contacts
Public ContactYue Chen
Accendatech CH Pty Ltd
Outcome results
None listed