Title
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

Description
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib versus Placebo Following Adjuvant Chemotherapy in Patients with Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation

Objective
Primary Objective:
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.
Secondary Objectives:
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.
To evaluate overall survival (OS) in patients treated with olaparib after adjuvant chemotherapy compared to those treated with adjuvant treatment alone.

Treatment All treatment will be administered on an outpatient basis. Please note that when a patient has been successfully randomized, the confirmation of randomization will indicate that the patient is on Arm X. The patient will actually be randomized to Arm A or B, but as this is a double-blind trial, that information cannot be displayed.

Arm A


Olaparib 300 mg by mouth (PO) twice daily (BID) for a total daily dosage of 600mg, Days 1-28

1 cycle = 28 days (4 weeks)

Repeat cycle every 4 weeks for a total of 12 cycles


Arm B


Placebo 300 mg by mouth (PO), twice daily (BID) for a total daily dosage of 600mg, Days 1-28

1 cycle = 28 days (4 weeks)

Repeat cycle every 4 weeks for a total of 12 cycles

Key Eligibility For study eligibility, review this study's ClinicialTrials.gov record.

Applicable Disease Sites
Pancreas

Participating Institutions
Johnson Creek, UW Cancer Center; Mercy Health Systems, Janesville ; UW Health 1 S. Park Medical Center; UW Health Eastpark Medical Center; UW Health University Hospital