This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-283 in patients with solid tumours.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
131
In the dose escalation part(phase 1a): the dose levels will be escalated following a modified 3+3 dose escalation scheme. In dose expansion phase(Phase 1b): Patients will be assigned to different groups based on their tumor types
Chris Obrien Lifehouse
Camperdown, New South Wales, Australia
North Coast Cancer Institute
Macquarie, New South Wales, Australia
Number of participants with adverse events in phase 1a
Time frame: From first dose to within 28 days of last dose of BGB-283, within 1 years in average
Objective response rate based on RECIST Version 1.1 in subjects with selected tumor types in phase 1b
Time frame: From the first administration of the investigational product to the end of the study treatment, within 1 year in average
Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast) in phase 1a
Time frame: During first 2 weeks
Area under the plasma concentration-time curve from time 0 to infinity time in (AUC∞) in phase 1a
Time frame: During first 2 weeks
Maximum plasma concentration (Cmax) in phase 1a
Time frame: During first 2 weeks
Time to reach maximum plasma concentration (tmax) in phase 1a
Time frame: During first 2 weeks
Terminal elimination half-life (t1/2) in phase 1a
Time frame: During first 2 weeks
Tumor response in phase 1a
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, within 1 year in average
Number of participants with adverse events in phase 1b
Time frame: From first dose to within 28 days of last dose of BGB-283, within 1 year in average
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Prince of Wales Hospital
Randwick, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Tasman Oncology Research Ltd
Southport Gold Coast, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
...and 9 more locations
Progression-free survival (PFS)
Time frame: The interval from study treatment initiation until the determination of disease progression or death, within 1 year in average