APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
This phase II trial investigates how well the addition of olaparib following completion of
surgery and chemotherapy works in treating patients with pancreatic cancer that has been
surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2.
Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA)
when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged
DNA, causing them to die. PARP inhibitors are a type of targeted therapy.
I. To determine the relapse-free survival (RFS)-benefit from the addition of a maintenance
olaparib following completion of chemotherapy in patients with resected pancreatic carcinoma
and a pathogenic germline or somatic mutation in BRCA1, BRCA2 or PALB2.
I. To evaluate RFS in patients with olaparib after perioperative chemotherapy compared to
those treated with perioperative therapy alone among patients who received prior
platinum-based perioperative chemotherapy.
II. To evaluate overall survival (OS) in patients treated with olaparib after adjuvant
chemotherapy compared to those treated with adjuvant treatment alone.
III. To analyze the efficacy of olaparib after chemotherapy in patients with a pathogenic
germline BRCA or PALB2 mutation compared to those with a somatic mutation.
IV. To analyze survival differences between patients who received neoadjuvant or
perioperative chemotherapy compared to those who received adjuvant therapy alone.
V. To analyze RFS and OS differences in those who received =< 3 months of perioperative
platinum chemotherapy compared to those who received > 3 months of perioperative platinum
VI. To analyze RFS and OS differences in those who received any platinum-based perioperative
chemotherapy compared to no-platinum based perioperative chemotherapy.
I. To analyze RFS and OS differences in patients who had R1 versus (vs) R0 resections, lymph
node positivity at resection, and/or elevated or rising CA 19-9 or CEA at time of study
enrollment in the post-operative setting.
II. To analyze RFS and OS differences with those who had resectable disease at diagnosis
compared to those who did not.
III. To analyze RFS and OS differences in those with gBRCA1 mutations compared to those with
gBRCA2 mutations and gPALB2 mutations.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive olaparib orally (PO) twice daily (BID) on days 1-28. Treatment
repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable
ARM II: Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for 12
cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 4 months for
year 1, then every 6 months for years 2-10.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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