The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2 (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and dose regimen is required prior to determining the next dose level and dose regimen for the next cohort. Phase 1B has PartA (BID Dosing Expansion) will investigate efficacy in participants with selected tumor types and further evaluate safety and tolerability of BGB 290 at recommended dose for future studies. and PartB (Food Effect) will investigate the food effect on the Pharmacokinetics (PK) of BGB 290 in participants with advanced solid tumors.
The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2 (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and dose regimen is required prior to determining the next dose level and dose regimen for the next cohort. Phase 1B has PartA (BID Dosing Expansion) will investigate efficacy in participants with selected tumor types and further evaluate safety and tolerability of BGB 290 at recommended dose for future studies. and PartB (Food Effect) will investigate the food effect on the PK of BGB 290 in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Gosford Hospital
Gosford, New South Wales, Australia
Cancer Care Wollongong
Wollongong, New South Wales, Australia
Flinders Medical Centre
Bedford PK, South Australia, Australia
Austin Health
Heidelberg, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Nucleus Network
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Objective response rate ([ORR]: Complete Response (CR) + Partial Response (PR)) based on RECIST Version 1.1
The primary endpoint of the study was a composite response rate that included ORR, a ≥50% decrease in serum prostate-specific antigen (PSA), and/or a decrease in circulating tumor cells.
Time frame: through study completion, an average of 1 year
Prostate-specific antigen (PSA) response (for prostate cancer participants only) based on Prostate Cancer Working Group 2 (PCWG2) criteria
The primary endpoint of the study was a composite response rate that included ORR, a ≥50% decrease in serum prostate-specific antigen (PSA), and/or a decrease in circulating tumor cells.
Time frame: through study completion, an average of 1 year
Primary PK 1
Primary PK parameter is area under the plasma concentration time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUClast).
Time frame: through study completion, an average of 1 year
Primary PK 2
Primary PK parameter is area under plasma concentration time curve (AUC).
Time frame: through study completion, an average of 1 year
Primary PK 3
Primary PK parameter is maximum observed plasma concentration (Cmax).
Time frame: through study completion, an average of 1 year
Progression free survival
Participants, who are withdrawn from the study without documented progression, will be censored at the date of the last tumor assessment when the participant was known to be progression free. Participants without post screening tumor assessments, but known to be alive will be censored at the time of the first administration of BGB 290).
Time frame: through study completion, an average of 1 year
Duration of response for responders (CR or PR) and duration of SD (defined only for participants whose confirmed best response is CR, PR, or SD.
For participants who are alive without progression following the qualifying response, duration of response will be censored on the date of last evaluable tumor assessment or last follow up for progression of disease).
Time frame: through study completion, an average of 1 year
The number and proportion of participants who achieve objective tumor response (complete response [CR], partial response [PR], and CR+PR) or stable disease (SD).
For ovarian cancer participants, tumor responses may also be evaluated using RECIST Version 1.1 combined with CA-125 based on the Gynecologic Cancer Intergroup (GCIG) criteria. For participants with prostate cancer, PCWG2 criteria may be used to evaluate responses by investigators.
Time frame: through study completion, an average of 1 year
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