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.
• Has a histologically or cytologically confirmed pancreatic adenocarcinoma
• Has advanced (unresectable or metastatic) pancreatic cancer by American Joint Committee on Cancer 8th Edition
• Has documented mutation in PALB2 gene (germline or somatic) that is predicted to be deleterious or suspected deleterious.
• Has at least one lesion (measurable) that can be accurately assessed at baseline by CT scan (or MRI, if the subject is allergic to CT contrast media) and is suitable for repeated assessment according to RECIST Version 1.1 criteria.
• Has a life expectancy ≥16 weeks.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 3 days of the treatment initiation.
• Has received at least one systemic treatment for advanced disease (locally advanced or metastatic disease).
• Has adequate organ function as defined in Table 2; all screening laboratory tests should be performed within 10 days prior to initiation of study intervention.
• Is male or female, who is at least 18 years of age at the time of signing the informed consent.
∙ Male Participants Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• A male participant must agree to use contraception ad detailed in Appendix D of this protocol during the treatment period and for at least 3 months following the last dose of Olaparib when having sexual intercourse with pregnant woman or with a WOPBP. Female partners of male patients should also use a highly effective form of contraception (\[see appendix D for acceptable methods\]) if they are of childbearing potential Male patients should not donate sperm throughout the period of taking olaparib and for 3 months following the last dose of olaparib.
∙ Female Participants Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• 11\. A female participant is eligible to participate if she is not pregnant\* (Appendix D), not breastfeeding and at least 1 of the following conditions applies:
‣ Not a WOCBP as defined in Appendix D
‣ OR
⁃ A WOCBP who agrees to follow the contraceptive guidance in Appendix D during treatment period and for least one month after the last dose of study intervention.
∙ Postmenopausal is defined as:
• Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
• Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50
• radiation-induced oophorectomy with last menses \>1 year ago
• chemotherapy-induced menopause with \>1 year interval since last menses
• surgical sterilisation (bilateral oophorectomy or hysterectomy)
⁃ evidence of non-childbearing status for women of childbearing potential is defined with negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1 (within 24 hours) and before every cycles.
∙ Informed Consent
• Has (or legally acceptable representative if applicable) provided written informed consent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main trial without participating in the FBR.