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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood
• Computed Tomography — PROCEDURE
  Undergo CT or CT/MRI
• Magnetic Resonance Imaging — PROCEDURE
  Undergo CT/MRI
• Olaparib — DRUG
  Given PO
• Placebo Administration — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Jun 22, 2021

Status verified

Dec 2025

Primary completion

Oct 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

152 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (olaparib)
  Patients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans or CT/MRI and collection of blood throughout the study.
• Placebo Comparator: Arm II (placebo)
  Patients receive placebo PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans or CT/MRI and collection of blood throughout the study.

Primary Outcome Measure

Improvement in relapse-free survival (RFS) [ Time Frame: From randomization to first documentation of disease recurrence (primary tumor relapse) or death, assessed from 22 months to 44 months ]

Locations (452)

Find similar trials in Anchorage, AK

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