Overview
This study was designed to evaluate the safety, tolerability, efficacy and pharmacokinetics of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy.
Description
This is a multicenter, single arm, open-label, dose-escalation phase 2 study of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM) after surgery and concomitant radio-chemotherapy Patients will receive JK-1201I combined with temozolomide until disease progression.
The primary objective of this study is to assess the safety of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy.
The secondary objectives of the study are to further evaluate the efficacy and pharmacokinetic profiles of JK-1201I.
Eligibility
Inclusion
Participants must meet all the following criteria to be eligible for randomization into the study:
- Male or female aged ≥18 years and ≤75 years.
- Patients newly diagnosed with glioblastoma either by imaging or pathology testing, Gross total resection equal to or greater than 80%.
- Patients must finish concurrent chemo-radiotherapy (CCRT) no sooner than 4 weeks and no later than 6 weeks.
- Stable dose or reduced dose of corticosteroid for more than 2 weeks.
- Karnofsky score ≥ 70.
- Life expectancy > 12 weeks.
- Adequate biological function.
- Men or women should be using adequate contraceptive measures during the study and for 6 months following the last dose of investigational product.
- Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
- MGMT unmethylation (only for Dose Expansion Cohort).
Exclusion
Participants who meet any of the following criteria will be disqualified from entering the study:
- Patients who received anti-tumor therapy except for concurrent chemo-radiotherapy (CCRT).
- Patient diagnosed with brain stem and spinal cord tumor as the primary tumor.
- Hypersensitivity to any ingredient of JK-1201I.
- Severe, uncontrolled or active cardiovascular diseases within the past 6 months.
- Inability to take medication by oral or presence of clinically significant gastrointestinal abnormalities that may affect absorption of investigational product.
- Uncontrolled seizures.
- Patient receiving prohibited medications and that cannot be discontinued at least 2 weeks prior to the start of treatment.
- Severe or uncontrolled high blood pressure.
- Unresolved toxicity from prior anti-tumor therapy.
- Women who are pregnant or Breast-feeding. 11 Positive human immunodeficiency virus antibody, active hepatitis B virus infection, or active hepatitis C virus infection.
- Have participated in another clinical trial within 4 weeks prior to informed consent form.
- History of mental disorders. 14. Other conditions that the investigator considers unsuitable to participate in this clinical trial.