Solid Tumors Clinical Trial
Official title:
A Phase I, Single and Multiple Dose Escalation/Expansion Study to Investigate 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 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."
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