Journal article
Phase 1A/1B dose-escalation and -expansion study to evaluate the safety, pharmacokinetics, food effects and antitumor activity of pamiparib in advanced solid tumours
JD Lickliter, M Voskoboynik, L Mileshkin, HK Gan, G Kichenadasse, K Zhang, M Zhang, Z Tang, M Millward
British Journal of Cancer | Published : 2022
Open access
Abstract
Background: Pamiparib, a PARP1/2 inhibitor, demonstrated antitumor activity in preclinical models. Methods: This Phase 1A/1B dose-escalation/dose-expansion study enrolled adults (≥18 years) with advanced/metastatic cancer. The dose-escalation phase evaluated the recommended Phase 2 dose (RP2D), maximum tolerated dose (MTD), and pharmacokinetics; the dose-expansion phase evaluated the antitumor activity and food effects. Results: Patients (N = 101) were enrolled in dose-escalation (n = 64) and dose-expansion (n = 37). During BID dose-escalation, dose-limiting toxicities were Grade 2 nausea (n = 1, 40 mg; n = 1, 80 mg); Grade 2 nausea and Grade 2 anorexia (n = 1, 120 mg), Grade 2 nausea, Grade..
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Funding Acknowledgements
The study protocol was developed by BeiGene, Ltd. in collaboration with the study investigators. BeiGene, Ltd. was also involved in data collection, analysis and interpretation of the results. Statistical analyses were performed by statisticians at BeiGene, Ltd. All authors were in agreement regarding the submission of this manuscript and vouch for the completeness and accuracy of the data. Professional medical writers, funded by BeiGene, Ltd., assisted with the development and submission of this manuscript under the authors' guidance. The corresponding author had full access to all of the study data and was responsible for the decision to submit the manuscript for publication.