What is olaparib studying for pancreatic cancer?

Olaparib is being studied to see if it can improve relapse-free survival in patients with pancreatic cancer who have had surgery and carry a mutation in BRCA1, BRCA2, or PALB2. Researchers want to find out if adding olaparib after chemotherapy helps prevent the cancer from returning. This study is sponsored by the National Cancer Institute.

Who may be eligible for this pancreatic cancer clinical trial?

Adults aged 18 years or older who have had pancreatic cancer removed by surgery and carry a BRCA1, BRCA2, or PALB2 mutation may be eligible. Participants should have completed at least 3 months of chemotherapy around the time of surgery and have no signs of cancer recurrence. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this pancreatic cancer clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID04858334

APOLLO A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Surgery and Chemotherapy in Patients With Resected Pancreatic Cancer and BRCA1, BRCA2, or PALB2 Mutation

Led by National Cancer Institute (NCI) · Updated on 2026-06-03

152

Participants Needed

454

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the addition of olaparib, a targeted therapy that blocks the PARP enzyme involved in DNA repair, in patients with pancreatic cancer who have had surgery to remove their tumor and carry a mutation in BRCA1, BRCA2, or PALB2. This phase II trial aims to determine if olaparib can improve relapse-free survival compared to placebo after chemotherapy completion. The study also explores overall survival and differences based on mutation type and chemotherapy received. Participants are randomly assigned to one of two groups. One group receives oral olaparib twice daily for 28-day cycles, up to 12 cycles, while the other group receives a placebo on the same schedule. Throughout treatment, patients undergo CT or MRI scans and blood collection. After treatment, patients are followed for up to 10 years with regular visits to monitor health and disease status. During the study, participants complete imaging scans and blood tests to assess disease progression and treatment effects. Researchers track relapse-free survival from the time of randomization until disease recurrence or death, with assessments extending up to 44 months. Safety and survival outcomes are monitored for up to 10 years. Follow-up visits occur 30 days after treatment and then every 4 months in the first year, followed by every 6 months for years 2 through 10.

CONDITIONS

Brief 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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Be 18 years of age or older
Have an ECOG performance status of 0 to 2
Have pancreatic cancer that was removed with curative intent and show no signs of recurrence
Have a pathogenic or likely pathogenic mutation in BRCA1, BRCA2, or PALB2 confirmed by a certified laboratory
Have received at least 3 months of perioperative multi-agent chemotherapy (up to 6 months allowed)
Be no more than 12 weeks from the last treatment (chemotherapy, radiotherapy, or surgery)
Have recovered from prior anti-cancer therapy side effects to grade 1 or less except for hair loss or neuropathy
Agree to germline testing if mutation was found only in tumor tissue
Have no active recurrent or metastatic pancreatic cancer based on scans within 4 weeks before randomization
Be at least 21 days and no more than 84 days from last treatment at randomization
Have adequate blood counts and organ function based on recent lab tests
Have controlled HIV, hepatitis B, or hepatitis C infections if applicable
Have no uncontrolled heart conditions or congenital long QT syndrome
Not be receiving other investigational agents
Not be pregnant or breastfeeding and agree to use effective contraception
Be able to understand and sign informed consent
Have recovered from any major surgery within 2 weeks before randomization

You will not qualify if you...

Have neuroendocrine tumors
Have had progressive pancreatic cancer during platinum-based therapy
Have allergic reactions to compounds similar to olaparib
Have a history of myelodysplastic syndrome or acute myeloid leukemia
Have uncontrolled gastrointestinal disorders affecting drug absorption
Have uncontrolled medical conditions or active infections that prevent study compliance
Have serious uncontrolled medical disorders such as recent heart attack or unstable arrhythmia
Be actively treated for another cancer except certain hormone or skin therapies
Use strong CYP3A4/5 inhibitors like ketoconazole or clarithromycin
Have uncontrolled cardiac problems or prolonged QTc intervals
Have psychiatric disorders that prevent informed consent

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