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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20150575 | Registry Identifier | Center for drug evaluation, CFDA |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I | Experimental | Approximately 25-35 Chinese subjects with local advanced or metastatic malignant solid tumor will be enrolled in the dose escalation stage of BGB-283 until maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) determination |
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| Stage II | Experimental | Approximately 15-30 melanoma subjects will be enrolled in dose expansion stage of BGB-283 |
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| Stage III | Experimental | 20 subjects will be enrolled for food effect stage of BGB-283 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-283 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average | 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 | 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) | Within 43 days since first dose | |
| Stage 3: Maximum plasma concentration (Cmax) | Within 43 days since first dose | |
| Stage 3: Terminal elimination half-life (t1/2) | Within 43 days since first dose | |
| Stage 3: Detect Ka for Pop-PK analysis | Within 43 days since first dose | |
| Stage 3: Detect CL/F for Pop-PK analysis | Within 43 days since first dose | |
| Stage 3: Detect Vc/F for Pop-PK analysis | Within 43 days since first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Area under the plasma concentration-time curve from time 0 to infinity time (AUC) | Within 43 days since first dose | |
| Stage 1: Maximum plasma concentration (Cmax) | Within 43 days since first dose |
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Inclusion Criteria:
Provided written informed consent prior to enrollment.
Male or female and between 18 and 75 years old.
A life expectancy of more than 12 weeks.
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.
In Stage II: we require advanced or metastatic melanoma with the B-RAF mutation.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
Able to swallow and retain oral medication.
Adequate bone marrow, liver, and renal function:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiang Li, MD | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| C000609386 | BGB-283 |
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| Stage 1: Terminal elimination half-life (t1/2) | Within 43 days since first dose |
| Stage 1: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1 | 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 | 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 | 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 |