About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Has a known additional malignancy that is progressing or requires active treatment. Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
Has myelodysplastic syndrome/acute myeloid leukaemia or features suggestive of MDS/AML.
3. Patients with symptomatic uncontrolled brain metastases and/or carcinomatous meningitis. Subject with previously treated brain metastasis may participate proved they are stable (without evidence of progression by imaging for at leat four weeks prior to the first dose of trial treatment and any neurological symptoms have returned to baseline), no evidence of new or enlarging brain metastases. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
4. Has a documented weigh loss > 10% from baseline during screening and/or decline in ECOG PS to >1 between visit and within 73 hours prior to first dose of therapy.
Trial design
Treatments tested in this trial
- Olaparib 150 MG