A Randomized Study of Olaparib or Placebo in Patients with Surgically Removed Pancreatic Cancer who have a BRCA1, BRCA2 or PALB2 Mutation (APOLLO)
https://www.facingourrisk.org/research-clinical-trials/study/140/olaparib-or-placebo-in-patients-with-surgically-removed-pancreatic-cancer-who-have-a-brca1-brca2-or-palb2-mutation
Clinicaltrials.gov identifier:
NCT04858334 (https://clinicaltrials.gov/show/NCT04858334)
Treatment
Study Contact Information:
For more information, please contact the Principal Investigator: Kim Reiss Binder, MD at Penn Medicine Abramson Cancer Center in Philadelphia by email or at 215-360-0735.
About the Study
The usual approach for patients with curable (i.e., non-metastatic) pancreatic cancer is a combination of surgery, FDA-approved chemotherapy, radiation (in select cases), then surveillance monitoring. This means that patients are typically monitored by their oncologist for evidence that the cancer has returned (recurrence), but they receive no additional treatment after the completion of surgery and chemotherapy.
The purpose of EA2192 / APOLLO is to compare the usual approach (observation) to treatment for one year with a drug called olaparib, in patients with a BRCA1, BRCA2 or PALB2 mutation. EA2192 / APOLLO will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if olaparib delays cancer recurrence compared to the usual approach of surveillance.
What the Study Entails
If you decide to participate in EA2192 / APOLLO, you will be assigned by chance (randomized) to one of the groups listed below. Neither you nor your doctor will be told which group you are in. Each patient has a 2/3 chance of being in Group 1 and a 1/3 chance of being in Group 2.
- Group 1: You will get a study drug called olaparib, which is a pill. You will take this pill by mouth twice daily for 12 months.
- Group 2: You will get a pill that looks like the study drug, but contains no medication (this is called a placebo pill). You will take the placebo by mouth twice daily for 12 months.
After you finish your study treatment, your doctor will continue to follow your condition every 8 weeks for up to 10 years.
Study Locations
A full list of sites can be found here. Study sites are enrolling in the following states:
- Alaska
- Arizona
- Arkansas
- California
- Colorado
- Idaho
- Illinois
- Iowa
- Kansas
- Kentucky
- Michigan
- Missouri
- Montana
- Nebraska
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Texas
- Washington
- Wisconsin
Lead Researchers/Study PIs and Affiliation
This study is run by the ECOG-ACRIN Cancer Research Group, which means it will be open at many centers around the country. Centers may be academic or community centers.
This Study is Open To:
Participants may be eligible if they have pancreatic cancer with a mutation (as identified in saliva, blood, and/or tumor tissue samples) in one of the following genes: BRCA1, BRCA2, or PALB2.
This Study is Not Open To:
The study is not open to patients who:
- have recurrent or metastatic pancreatic cancer.
- do not have a mutation in BRCA1, BRCA2 or PALB2 identified through testing of saliva, blood, and/or tumor tissue samples.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.