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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ovarian cancer, fallopian cancer, or primary peritoneal cancer | Experimental | 60mg BID oral. |
|
| Breast Cancer | Experimental | 60mg BID Ora |
|
| Prostate Cancer | Experimental | 60mg BID Oral |
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| Small Cell Lung Cancer | Experimental | 60mg BID Oral |
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| Gastric Cancer | Experimental | 60mg BID Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-290 | Drug |
| ||
| BGB-290 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | through study completion, an average of 1 year |
| Primary PK 2 | Primary PK parameter is area under plasma concentration time curve (AUC). | through study completion, an average of 1 year |
| Primary PK 3 | Primary PK parameter is maximum observed plasma concentration (Cmax). | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | through study completion, an average of 1 year |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Millward, MD | Linear Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gosford Hospital | Gosford | New South Wales | 2250 | Australia | ||
| Cancer Care Wollongong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Lickliter JD, Gan HK, Meniawy T, Yang J, Wang L, Luo LS, Millward M. A phase I dose-escalation study of BGB-290, a novel PARP1/2 selective inhibitor in patients with advanced solid tumors. Journal of Clinical Oncology. 2016; 34(15): DOI: 10.1200/JCO.2016.34.15_suppl.e17049 | ||
| 34795408 | Derived | Lickliter JD, Voskoboynik M, Mileshkin L, Gan HK, Kichenadasse G, Zhang K, Zhang M, Tang Z, Millward M. Phase 1A/1B dose-escalation and -expansion study to evaluate the safety, pharmacokinetics, food effects and antitumor activity of pamiparib in advanced solid tumours. Br J Cancer. 2022 Mar;126(4):576-585. doi: 10.1038/s41416-021-01632-2. Epub 2021 Nov 18. | |
| 33128299 |
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| ID | Term |
|---|---|
| C000707927 | pamiparib |
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| Drug |
|
| BGB-290 | Drug |
|
| BGB-290 | Drug |
|
| BGB-290 | Drug |
|
| 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). | 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. | through study completion, an average of 1 year |
| Wollongong |
| New South Wales |
| 2500 |
| Australia |
| Flinders Medical Centre | Bedford PK | South Australia | 5042 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| Derived |
| Xu B, Yin Y, Dong M, Song Y, Li W, Huang X, Wang T, He J, Mu X, Li L, Mu S, Zhang W, Li M. Pamiparib dose escalation in Chinese patients with non-mucinous high-grade ovarian cancer or advanced triple-negative breast cancer. Cancer Med. 2021 Jan;10(1):109-118. doi: 10.1002/cam4.3575. Epub 2020 Oct 31. |