Health Trials

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

ConditionsPancreatic Acinar Cell CarcinomaPancreatic Adenosquamous CarcinomaPancreatic Squamous Cell CarcinomaResectable Pancreatic Acinar Cell CarcinomaResectable Pancreatic AdenocarcinomaResectable Pancreatic Adenosquamous CarcinomaResectable Pancreatic Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

Qualifiers

STEP 0 (PRE-REGISTRATION) INCLUSION CRITERIA

Patient must be >= 18 years of age on day of consent

Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Olaparib
  • Placebo Administration

Treatment groups

152 Participants
are divided into 2 treatment groups

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov