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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

NCT04858334 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Pancreatic Acinar Cell Carcinoma
  • Pancreatic Adenosquamous Carcinoma
  • Pancreatic Squamous Cell Carcinoma
  • Resectable Pancreatic Acinar Cell Carcinoma
  • Resectable Pancreatic Adenocarcinoma
  • Resectable Pancreatic Adenosquamous Carcinoma
  • Resectable Pancreatic Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Computed Tomography

Undergo CT or CT/MRI

PROCEDURE

Magnetic Resonance Imaging

Undergo CT/MRI

DRUG

Olaparib

Given PO

DRUG

Placebo Administration

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kim A Reiss Binder · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2027-10-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States
  • Israel
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858334 on ClinicalTrials.gov