This study will evaluate the safety, tolerability, pharmacokinetics, food effect, and preliminary antitumor activities of BGB-283 in Chinese subjects with local advanced or metastatic malignant solid tumor.
"This study is conducted on the basis of the completed multi-dose, dose escalation, Phase IA trial in Australia, is a dose-finding, dose expansion and food effects study of BGB-283 capsules in Chinese patients with locally advanced or metastatic solid tumor to determine the tolerability, safety, pharmacokinetic profiles, preliminary efficacy, food effects under high-fat meal on the absorption and metabolism of BGB-283, and preliminary anti-tumor efficacy. The study was conducted in three phases: Stage I for dose escalation, Stage II for dose expansion and Stage III for food effects on pharmacokinetics under high fat meal. Stage I Dose escalation: In a open-label, dose-escalation design, dose escalation will be performed with the '3 + 3' scheme and the dosage levels of BGB-283 capsules will be gradually increased. Stage II Dose expansion: 20 mg/qd and 30 mg/qd are considered as effective and safe doses, based on preliminary results from Phase IA clinical studies in Australia. To further understand the preliminary pharmacodynamic results of BGB-283 in Chinese patients with malignant melanoma, 20mg/qd dose expansion study in B-RAF mutated malignant melanoma will be further explored if it has been proved to be a safe dose in Chinese population according to the '3 + 3' scheme. Stage III uses multi-center, open, two-group crossover self-control design to compare the high-fat meal effect on pharmacokinetics."
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Stage 1: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average
Time frame: From signing the informed consent form and throughout the study, 1 year in average
Stage 2: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1
Time frame: Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, 1 year in average
Stage 3: Area under the plasma concentration-time curve from time 0 to infinity time (AUC)
Time frame: Within 43 days since first dose
Stage 3: Maximum plasma concentration (Cmax)
Time frame: Within 43 days since first dose
Stage 3: Terminal elimination half-life (t1/2)
Time frame: Within 43 days since first dose
Stage 3: Detect Ka for Pop-PK analysis
Time frame: Within 43 days since first dose
Stage 3: Detect CL/F for Pop-PK analysis
Time frame: Within 43 days since first dose
Stage 3: Detect Vc/F for Pop-PK analysis
Time frame: Within 43 days since first dose
Stage 1: Area under the plasma concentration-time curve from time 0 to infinity time (AUC)
Time frame: Within 43 days since first dose
Stage 1: Maximum plasma concentration (Cmax)
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Time frame: Within 43 days since first dose
Stage 1: Terminal elimination half-life (t1/2)
Time frame: Within 43 days since first dose
Stage 1: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1
Time frame: Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, 1 year in average
Stage 2: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average
Time frame: From signing the informed consent form and throughout the study, 1 year in average
Stage 3: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1
Time frame: Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, 1 year in average