The Study of BGB-283 in Chinese Subjects With Local Advanced or Metastatic Malignant Solid Tumor
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About
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.
Full description
"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."
Enrollment
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Volunteers
Inclusion criteria
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Provided written informed consent prior to enrollment.
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Male or female and between 18 and 75 years old.
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A life expectancy of more than 12 weeks.
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Stage I and III: Histologically or cytologically confirmed advanced or metastatic solid tumor for which no effective standard therapy is available. We simultaneously require patients with one of B-RAF, N-RAS, or K-RAS mutation positive solid tumor.
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In Stage II: we require advanced or metastatic melanoma with the B-RAF mutation.
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Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
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Able to swallow and retain oral medication.
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Adequate bone marrow, liver, and renal function:
- Hemoglobin > 90 g/L
- Absolute neutrophil count ≥ 1.5x10^9/L
- Platelets ≥ 100 x10^9/L
- Total bilirubin ≤1.5 times the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with known liver metastasis)
- Creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft Gault formula).
Exclusion criteria
- Female subjects who are pregnant or lactating.
- Prior chemotherapy, radiotherapy, immunotherapy or any investigational therapies used to control cancer must have been completed at least 4 weeks or at least 5 half-lives (whichever is shorter before study drug administration, but at least 21 days)
- Any major surgery within 28 days prior to enrollment.
- Any radiotherapy for metastatic foci within 14 days prior to enrollment,
- Unresolved toxicity > Grade 1 (according to NCI-CTCAE, Version 4.03) from previous anti cancer therapy.
- History or presence of gastrointestinal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Any clinical significant active infection that need systematic treatment, including HIV positive subjects, or known Hepatitis B or C.
Trial design
Primary purpose
Allocation
Interventional model
Masking
42 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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