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NCT04858334 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Resectable Pancreatic Adenocarcinoma and Pancreatic Acinar Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 152
- Enrollment target
- 20
- Study locations
NCT04858334: Recruiting Phase 2 study of Resectable Pancreatic Adenocarcinoma and Pancreatic Acinar Cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT04858334 is a Phase 2 study of Resectable Pancreatic Adenocarcinoma and Pancreatic Acinar Cell Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 152 participants, above the 107-participant average among 5 other Resectable Pancreatic Adenocarcinoma trials with a reported enrollment target (42% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04858334, a Phase 2 study of Resectable Pancreatic Adenocarcinoma and Pancreatic Acinar Cell Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 152 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Will demonstrate an improvement in the RFS from 22 months to 44 months (hazard ratio 0.5) in patients treated with olaparib after perioperative (neoadjuvant, adjuvant or a combination) chemotherapy compared to those treated with perioperative therapy alone.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Olaparib
- DRUG Placebo Administration
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Memorial Medical Center - Modesto
- Palo Alto Medical Foundation-Gynecologic Oncology - Mountain View
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2021-06-22 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 2 |
What NCT04858334 shows while recruiting
NCT04858334 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 107-participant average among 5 other Resectable Pancreatic Adenocarcinoma trials with a reported enrollment target (42% higher).
The record links to 7 conditions, with Resectable Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04858334 names 20 study sites across 4 states, led by Alaska, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04858334 about?
NCT04858334 is a clinical study titled "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". 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,...
What is the current status of trial NCT04858334?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2021-06-22. Estimated completion is 2027-10-31.
What conditions does trial NCT04858334 study?
This clinical trial studies the following conditions: Resectable Pancreatic Adenocarcinoma, Pancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma, Resectable Pancreatic Carcinoma, Pancreatic Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04858334?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Olaparib (DRUG), Placebo Administration (DRUG).
Who is sponsoring clinical trial NCT04858334?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04858334 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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