Amgen Europe BV

Primary Objectives: To determine the maximum tolerated dose (MTD) or recommended combined dose of AMG 193 in combination with gemcitabine and nab-paclitaxel or mFOLFIRINOX in adult subjects with locally advanced or metastatic MTAP-deficient pancreatic ductal adenocarcinoma (PDAC); To determine the safety profile of AMG 193 in combination with gemcitabine and nab-paclitaxel or mFOLFIRINOX in adult subjects with locally advanced or metastatic MTAP-deficient PDAC. Secondary Objectives: To evaluate the antitumor activity of AMG 193 in combination with gemcitabine and nab-paclitaxel or mFOLFIRINOX in adult subjects with locally advanced or metastatic MTAP-deficient PDAC; To evaluate the pharmacokinetics (PK) of AMG 193 in combination with gemcitabine and nab-paclitaxel or mFOLFIRINOX in adult subjects with locally advanced or metastatic MTAP-deficient PDAC.

Primary Objective: In the post-marketing setting, estimate the incidence of adverse events, serious adverse events, and adverse drug reactions (ADRs) in PMO patients treated with Prolix based on the Chinese Prescribing Information (PI) Secondary Objectives: 1) Describe the effectiveness of Prolix by assessing the percentage change from baseline in lumbar spine and/or total hip and/or femoral neck bone mineral density (BMD) (if the corresponding BMD can be obtained according to local standard of care) 2) Describe the incidence of clinical fractures during Prolix treatment 3) Describe the characteristics of patients treated with Prolix in the post-marketing setting