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
Pancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma, Pancreatic Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Pancreatic Acinar Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- STEP 0 (PRE-REGISTRATION) INCLUSION CRITERIA
- Patient must be >= 18 years of age on day of consent
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator
- NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with neuroendocrine tumors are excluded from enrolling
- Patient must (1) be planning to receive, (2) be receiving or (3) have received at least three combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 month course)
- Patient must be no more than 12 weeks from their most recent treatment (this may be chemotherapy, radiotherapy or surgery)
- Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) certified or equivalently-accredited laboratory. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org
- STEP 1 (RANDOMIZATION) INCLUSION CRITERIA
- Patient must have met the eligibility criteria outlined above
- Patient must have undergone at least 3 combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 months course)
- Central expert reviewer must have determined the patient eligible for randomization after review of local genetic testing reports
- If mutation in BRCA1, BRCA2 or PALB2 was identified in tumor tissue and the patient has not previously undergone germline testing, the patient must agree to undergo germline testing
- Patient must not have previously had evidence of progressive pancreatic cancer while receiving platinum-based therapy
- Patient must be >= 21 days (three weeks) from their last treatment (including chemotherapy radiotherapy or surgery) but =< 84 days (twelve weeks) from their last treatment at the time of Step 1 randomization. Patients who have received neoadjuvant and/or adjuvant radiotherapy are eligible
- Patient must have recovered from any adverse events due to prior anti-cancer therapy (i.e., have no residual toxicities > grade 1 with the exception of alopecia and/or neuropathy)
- Leukocytes >= 3,000/mcL (obtained =< 28 days prior to Step 1 randomization)
- Absolute neutrophil count >= 1,500/mcL (obtained =< 28 days prior to Step 1 randomization)
- Platelets >= 100,000/mcL (obtained =< 28 days prior to Step 1 randomization)
- Hemoglobin >= 9.0 g/dL with no blood transfusion in the past 28 days (obtained =< 28 days prior to Step 1 randomization)
- Total bilirubin =< institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin =< 2.5 ULN of the direct bilirubin (obtained =< 28 days prior to Step 1 randomization)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 institutional ULN (obtained =< 28 days prior to Step 1 randomization)
- Creatinine =< institutional ULN OR calculated Cockcroft Gault creatinine clearance > 50 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2 (obtained =< 28 days prior to Step 1 randomization)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patient must have the ability to understand the willingness to sign a written informed consent document, or have legally authorized representative provide authorization to participate
Exclusion Criteria:
- STEP 1 (RANDOMIZATION) EXCLUSION CRITERIA
- Patient must have no evidence of recurrent or metastatic pancreatic cancer at the time of randomization as documented by baseline scans obtained =< 4 weeks prior to Step 1 randomization
- Patient must not be receiving any other investigational agents at the time of Step 1 randomization and while on protocol treatment
- Patient must not have any history of allergic reactions attributed to compounds of similar chemical or biological composition to olaparib
- Patient must not have any personal history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
- Patient must not have any uncontrolled gastrointestinal disorder that would, in the opinion of the investigator, interfere with the ingestion or absorption of olaparib
- Patient must not be pregnant or breast-feeding due the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6 months after the last dose of protocol treatment for female patients and for 3 months after the last dose of protocol treatment for male patients. Patients must also not donate sperm while on protocol treatment and for 3 months after the last dose of protocol treatment. Patients must also not breast-feed while on protocol treatment and for 1 month after the last dose of protocol treatment
- Patient must not have resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT (QTc) prolongation > 500 ms, electrolyte disturbances, etc.) or have congenital long QT syndrome
- Concomitant use of known potent CYP3A4/5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir is prohibited
- Patients who are being actively treated for an ongoing concurrent malignancy are ineligible, with the exception of those receiving adjuvant hormone therapies and those receiving topical therapies for skin cancers
- Patient must not have, in the opinion of the investigator, any other concurrent medical condition that would prevent the patient from complying with the study procedures
- Patient must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent
- Patient must not have had major surgery within 2 weeks prior to randomization and patients must have recovered from any effects of any major surgery
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial HospitalRecruiting
- Kingman Regional Medical CenterRecruiting
- Cancer Center at Saint Joseph's
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroRecruiting
- Mission Hope Medical Oncology - Arroyo Grande
- PCR Oncology
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Pacific Central Coast Health Center-San Luis Obispo
- Mission Hope Medical Oncology - Santa Maria
- Northbay Cancer CenterRecruiting
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Porter Adventist Hospital
- Mercy Medical Center
- Southwest Oncology PC
- Saint Anthony Hospital
- Littleton Adventist Hospital
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- Parker Adventist Hospital
- Saint Mary Corwin Medical Center
- Sibley Memorial HospitalRecruiting
- AdventHealth AltamonteRecruiting
- AdventHealth Celebration
- UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- AdventHealth Kissimmee
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- UM Sylvester Comprehensive Cancer Center at KendallRecruiting
- AdventHealth Medical Group Urology at Orlando
- AdventHealth OrlandoRecruiting
- AdventHealth East Orlando
- UM Sylvester Comprehensive Cancer Center at PlantationRecruiting
- AdventHealth Winter Park
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Saint Anthony's Health
- Rush - Copley Medical Center
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology ClinicRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Illinois CancerCare-DixonRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Elmhurst Memorial HospitalRecruiting
- Illinois CancerCare-Eureka
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment Center
- Illinois CancerCare-Kewanee ClinicRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Good Samaritan Regional Health Center
- Edward Hospital/Cancer CenterRecruiting
- UC Comprehensive Cancer Center at Silver CrossRecruiting
- Cancer Care Center of O'FallonRecruiting
- University of Chicago Medicine-Orland ParkRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of Illinois
- Illinois CancerCare-PeruRecruiting
- Valley Radiation Oncology
- Edward Hospital/Cancer Center?PlainfieldRecruiting
- Illinois CancerCare-PrincetonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- The Carle Foundation Hospital
- Illinois CancerCare - WashingtonRecruiting
- Rush-Copley Healthcare Center
- Northwest Cancer Center - Main CampusRecruiting
- Northwest Oncology LLCRecruiting
- Saint Mary Medical CenterRecruiting
- The Community HospitalRecruiting
- Memorial Hospital of South BendRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic - AmesRecruiting
- McFarland Clinic - BooneRecruiting
- Saint Anthony Regional HospitalRecruiting
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Alegent Health Mercy Hospital
- Greater Regional Medical CenterRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical CenterRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer CenterRecruiting
- Trinity Regional Medical Center
- McFarland Clinic - JeffersonRecruiting
- McFarland Clinic - MarshalltownRecruiting
- Methodist West Hospital
- Mercy Medical Center-West LakesRecruiting
- University of Kansas Clinical Research Center
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- HaysMed University of Kansas Health SystemRecruiting
- University of Kansas Cancer CenterRecruiting
- Lawrence Memorial HospitalRecruiting
- Olathe Health Cancer CenterRecruiting
- University of Kansas Cancer Center-Overland ParkRecruiting
- University of Kansas Hospital-Indian Creek CampusRecruiting
- Ascension Via Christi - Pittsburg
- Salina Regional Health CenterRecruiting
- University of Kansas Health System Saint Francis CampusRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Saint Joseph London
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Jewish Hospital Medical Center South
- Louisiana Hematology Oncology Associates LLCRecruiting
- Mary Bird Perkins Cancer CenterRecruiting
- Ochsner Hematology Oncology North Shore - Covington (West Region)Recruiting
- Ochsner Medical Center JeffersonRecruiting
- Hickman Cancer Center
- Saint Joseph Mercy HospitalRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
- Beaumont Hospital - Farmington HillsRecruiting
- Genesee Cancer and Blood Disease Treatment CenterRecruiting
- Genesee Hematology Oncology PCRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Academic Hematology Oncology SpecialistsRecruiting
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Toledo Clinic Cancer Centers-Monroe
- Ascension Providence Hospitals - NoviRecruiting
- William Beaumont Hospital-Royal OakRecruiting
- Ascension Providence Hospitals - SouthfieldRecruiting
- Bhadresh Nayak MD PC-Sterling HeightsRecruiting
- William Beaumont Hospital - TroyRecruiting
- Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Huron Gastroenterology PCRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Saint Luke's Hospital of DuluthRecruiting
- Abbott-Northwestern HospitalRecruiting
- Mayo Clinic in Rochester
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- Baptist Cancer Center-GrenadaRecruiting
- Baptist Memorial Hospital and Cancer Center-Union CountyRecruiting
- Baptist Memorial Hospital and Cancer Center-OxfordRecruiting
- Baptist Memorial Hospital and Cancer Center-DesotoRecruiting
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Saint Francis Medical CenterRecruiting
- Southeast Cancer Center
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Truman Medical Centers
- Saint Luke's Hospital of Kansas CityRecruiting
- University of Kansas Cancer Center - NorthRecruiting
- University of Kansas Cancer Center - Lee's SummitRecruiting
- Saint Luke's East - Lee's SummitRecruiting
- University of Kansas Cancer Center at North Kansas City HospitalRecruiting
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Mercy Hospital South
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Mercy Hospital Washington
- Saint Patrick Hospital - Community Hospital
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Midlands Community Hospital
- Carson Tahoe Regional Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven Hills
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- GenesisCare USA - Henderson
- Las Vegas Urology - Green Valley
- Las Vegas Urology - Pebble
- Urology Specialists of Nevada - Green Valley
- Las Vegas Urology - Pecos
- Desert West Surgery
- OptumCare Cancer Care at CharlestonRecruiting
- University Medical Center of Southern Nevada
- Hope Cancer Care of Nevada
- Radiation Oncology Centers of Nevada Central
- Urology Specialists of Nevada - Central
- GenesisCare USA - Las Vegas
- Sunrise Hospital and Medical Center
- Las Vegas Prostate Cancer Center
- Las Vegas Urology - Sunset
- Urology Specialists of Nevada - Southwest
- Radiation Oncology Centers of Nevada Southeast
- Ann M Wierman MD LTD
- Comprehensive Cancer Centers of Nevada - Northwest
- GenesisCare USA - Vegas Tenaya
- Las Vegas Urology - Cathedral Rock
- Las Vegas Urology - Smoke Ranch
- OptumCare Cancer Care at MountainView
- Urology Specialists of Nevada - Northwest
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
- Comprehensive Cancer Centers of Nevada - Town Center
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of Nevada
- GenesisCare USA - Fort Apache
- OptumCare Cancer Care at Fort ApacheRecruiting
- Comprehensive Cancer Centers of Nevada - Central Valley
- University Cancer Center
- Hope Cancer Care of Nevada-Pahrump
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Cooper Hospital University Medical Center
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Holy Name Hospital
- MD Anderson Cancer Center at Cooper-Voorhees
- University of New Mexico Cancer CenterRecruiting
- Memorial Sloan Kettering CommackRecruiting
- Northwell Health Cancer Institute at HuntingtonRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Southeastern Medical Oncology Center-ClintonRecruiting
- Southeastern Medical Oncology Center-GoldsboroRecruiting
- Southeastern Medical Oncology Center-JacksonvilleRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Miami Valley Hospital SouthRecruiting
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Dayton Blood and Cancer CenterRecruiting
- Miami Valley HospitalRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital NorthRecruiting
- Atrium Medical Center-Middletown Regional HospitalRecruiting
- Kettering Medical CenterRecruiting
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-ToledoRecruiting
- Upper Valley Medical CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical CenterRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Oregon Health and Science UniversityRecruiting
- Saint Charles Health System-Redmond
- Bryn Mawr HospitalRecruiting
- Main Line Health Center-Collegeville
- Main Line Health Center-Exton
- Riddle Memorial HospitalRecruiting
- Paoli Memorial HospitalRecruiting
- University of Pennsylvania/Abramson Cancer CenterRecruiting
- Fox Chase Cancer Center
- Lankenau Medical CenterRecruiting
- Avera Cancer Institute-AberdeenRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Avera Cancer InstituteRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Baptist Memorial Hospital and Cancer Center-ColliervilleRecruiting
- Baptist Memorial Hospital and Cancer Center-MemphisRecruiting
- Saint Joseph Regional Cancer Center
- Farmington Health CenterRecruiting
- University of Utah Sugarhouse Health CenterRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- Norris Cotton Cancer Center-NorthRecruiting
- Providence Regional Cancer System-Aberdeen
- MultiCare Auburn Medical CenterRecruiting
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-EdmondsRecruiting
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- MultiCare Gig Harbor Medical ParkRecruiting
- Swedish Cancer Institute-IssaquahRecruiting
- Kadlec Clinic Hematology and OncologyRecruiting
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- MultiCare Good Samaritan HospitalRecruiting
- Valley Medical Center
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Swedish Medical Center-Cherry Hill
- Swedish Medical Center-First HillRecruiting
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - DowntownRecruiting
- MultiCare Deaconess Cancer and Blood Specialty Center - NorthRecruiting
- Franciscan Research Center-Northwest Medical Plaza
- MultiCare Tacoma General HospitalRecruiting
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Providence Regional Cancer System-Yelm
- West Virginia University HealthcareRecruiting
- ThedaCare Regional Cancer CenterRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- UW Cancer Center Johnson CreekRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- ProHealth Waukesha Memorial HospitalRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Marshfield Medical Center - WestonRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I (olaparib)
Arm II (placebo)
Patients receive olaparib PO BID on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans/MRI and collection of blood throughout the study.
Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans/MRI and collection of blood throughout the study.