Metastatic Pancreatic Cancer Clinical Trial
Official title:
A Phase II Multicentric Study of Olaparib in PALB2-related Advanced Pancreatic Cancer (PALBOLA)
This is a Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced/metastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease.
This is a Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced/metastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease. After screening, 16 eligible participants with germline or somatic PALB2 mutations will be enrolled in this study. All participants will receive Olaparib 300 mg twice a daily (BID). Study intervention will continue until documented PD, unacceptable AEs, intercurrent illness that prevents further administration of the study intervention, investigator's decision to discontinue the participant, participant withdrawal of consent, pregnancy of the participant, administrative reasons requiring cessation of study intervention. After documented PD, each participant will be contacted by telephone every 12 weeks (+-14 days) to assess for survival status until withdrawal of consent to participate in the study, becoming lost to follow up, death or end of the study, whichever occurs first. During treatment, efficacy will be evaluated using ORR, PFS, DOC and DCR using RECIST 1.1 Efficacy will also be evaluated by assessing OS. Participants will be evaluated with radiographic imaging to assess response to intervention at regular intervals throughout the study. ;
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