Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
Purpose
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.
Conditions
- Fallopian Tube Endometrioid Adenocarcinoma
- Fallopian Tube High Grade Serous Adenocarcinoma
- FIGO Stage III Ovarian Cancer 2014
- FIGO Stage IV Ovarian Cancer 2014
- Ovarian Carcinoma
- Ovarian High Grade Endometrioid Adenocarcinoma
- Ovarian High Grade Serous Adenocarcinoma
- Primary Peritoneal Endometrioid Adenocarcinoma
- Primary Peritoneal High Grade Serous Adenocarcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology
and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types:
- High grade serous
- High grade endometrioid, and/or
- Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline
or somatic)
- Submission of pathology report is required
- Ovarian cancer = ovarian, fallopian, or primary peritoneal cancer
- Patients must have:
- Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to
be pathogenic or suspected pathogenic (deleterious alteration)
- Submission of testing report is required. OR
- BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or
academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory
(e.g., Myriad MyChoice©)
- Submission of testing report is required
- Patient must have undergone cytoreductive surgery (primary or interval)
- Patients must have completed first line platinum-based therapy prior to
registration:
- Platinum based chemotherapy course must have consisted of a minimum of 4
treatment cycles and a maximum of 9, although it is strongly recommended that
patients receive at least 6 cycles unless medically contraindicated
- For those receiving less than 6 cycles of platinum-based therapy, the
reason for this must be documented and could include hematologic toxicity
or non-hematologic toxicities directly related to therapy
- Intravenous, intraperitoneal, or neoadjuvant platinum-based chemotherapy is
allowed; for weekly therapy, three weeks are considered one cycle
- Patients must not have received an investigational agent during their first
line course of chemotherapy
- Patients must have, in the opinion of the investigator, no clinical evidence of
disease progression following completion of this chemotherapy course (partial or
complete response to platinum-based chemotherapy)
- Patients with treated brain metastases are eligible if follow up brain imaging after
central nervous system (CNS) directed therapy shows no evidence of progression
following completion of this chemotherapy course (partial or complete response to
platinum-based chemotherapy)
- Patients must be randomized at least 3 weeks and no more than 12 weeks after their
last dose of chemotherapy (last dose is the day of the last infusion of platinum
agent)
- No previous treatment with a PARP inhibitor, including olaparib, niraparib, and
rucaparib
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Not pregnant and not nursing
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3
- Platelets ≥ 100,000 cells/mm^3
- Hemoglobin ≥ 9 g/dl
- Creatinine clearance (CrCL) of > 30 mL/min by the Cockcroft-Gault formula
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with
known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be
enrolled)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x
institutional ULN
- Patients with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification. To be
eligible for this trial, patients should be class 2B or better
- No active infection requiring parental antibiotic(s)
- No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not
diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or
need for drainage nasogastric or gastrostomy tube
- No current inability to swallow orally administered medication
- No history of myelodysplastic syndrome and/or acute myeloid leukemia
- No history of allogeneic bone marrow transplant
- No concomitant use of strong or moderate CYP3A inducers
- No known hypersensitivity to olaparib or any of the excipients of the product
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Arm I (olaparib, bevacizumab) |
Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT and/or MRI throughout the study. |
|
Experimental Arm II (olaparib, bevacizumab) |
Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT and/or MRI throughout the study. |
|
Recruiting Locations
Birmingham, Alabama 35233
Anchorage, Alaska 98508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Phoenix, Arizona 85004
Fort Smith, Arkansas 72903
Site Public Contact
800-378-9373
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
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501-686-8274
Antioch, California 94531
Arroyo Grande, California 93420
Auburn, California 95602
Auburn, California 95603
Bellflower, California 90706
Berkeley, California 94704
Beverly Hills, California 90211
Burbank, California 91505
Burlingame, California 94010
Cameron Park, California 95682
Carmichael, California 95608
Carmichael, California 95608
Castro Valley, California 94546
Davis, California 95616
Dublin, California 94568
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877-642-4691
Elk Grove, California 95758
Fremont, California 94538
Fremont, California 94538
Fresno, California 93720
Fresno, California 93720
Harbor City, California 90710
Irvine, California 92618
La Jolla, California 92093
Los Angeles, California 90027
Los Angeles, California 90034
Los Angeles, California 90048
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310-423-8965
Merced, California 95340
Modesto, California 95355
Modesto, California 95356
Mountain View, California 94040
Mountain View, California 94040
Napa, California 94558
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707-521-3830
Novato, California 94945
Oakland, California 94611
Oakland, California 94611
Palo Alto, California 94301
Palo Alto, California 94304
Panorama City, California 91402
Pasadena, California 91105
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626-535-2420
Rancho Cordova, California 95670
Redwood City, California 94063
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877-642-4691
Richmond, California 94801
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Rohnert Park, California 94928
Roseville, California 95661
Roseville, California 95661
Roseville, California 95661
Roseville, California 95678
Sacramento, California 95814
Sacramento, California 95816
Sacramento, California 95816
Sacramento, California 95823
Sacramento, California 95823
San Diego, California 92120
San Francisco, California 94115
San Francisco, California 94115
San Jose, California 95119
San Leandro, California 94577
San Luis Obispo, California 93401
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San Rafael, California 94903
Santa Barbara, California 93105
Santa Clara, California 95051
Santa Cruz, California 95065
Santa Cruz, California 95065
Santa Maria, California 93444
Santa Rosa, California 95403
Santa Rosa, California 95403
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707-521-3830
Santa Rosa, California 95403
Santa Rosa, California 95405
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Aurora, Colorado 80045
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'Aiea, Hawaii 96701
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Post Falls, Idaho 83854
Sandpoint, Idaho 83864
Twin Falls, Idaho 83301
Alton, Illinois 62002
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618-463-5623
Bloomington, Illinois 61704
Canton, Illinois 61520
Carbondale, Illinois 62902
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Carthage, Illinois 62321
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Centralia, Illinois 62801
Chicago, Illinois 60612
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312-864-5204
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319-363-2690
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712-322-4136
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Iowa City, Iowa 52242
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Garden City, Kansas 67846
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Bardstown, Kentucky 40004
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502-562-3429
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270-575-2928
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Baton Rouge, Louisiana 70808
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225-765-7659
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Scarborough, Maine 04074
Bethesda, Maryland 20889-5600
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301-319-2100
Elkton, Maryland 21921
Alma, Michigan 48801
Alpena, Michigan 49707
Ann Arbor, Michigan 48106
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Battle Creek, Michigan 49017
Brighton, Michigan 48114
Brighton, Michigan 48114
Brighton, Michigan 48116
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800-865-1125
Canton, Michigan 48188
Canton, Michigan 48188
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Detroit, Michigan 48236
East China Township, Michigan 48054
Escanaba, Michigan 49829
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Gladwin, Michigan 48624
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49009
Kalamazoo, Michigan 49048
Lansing, Michigan 48912
Livonia, Michigan 48154
Macomb, Michigan 48044
Macomb, Michigan 48044
Midland, Michigan 48670
Mount Pleasant, Michigan 48858
Muskegon, Michigan 49444
Niles, Michigan 49120
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616-391-1230
Norton Shores, Michigan 49444
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Reed City, Michigan 49677
Saginaw, Michigan 48601
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Tawas City, Michigan 48764
Traverse City, Michigan 49684
Warren, Michigan 48093
Warren, Michigan 48093
Warren, Michigan 48093
Wyoming, Michigan 49519
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48197
Aitkin, Minnesota 56431
Baxter, Minnesota 56425
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218-828-2880
Brainerd, Minnesota 56401
Burnsville, Minnesota 55337
Cambridge, Minnesota 55008
Coon Rapids, Minnesota 55433
Deer River, Minnesota 56636
Detroit Lakes, Minnesota 56501
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Edina, Minnesota 55435
Ely, Minnesota 55731
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218-365-7900
Fosston, Minnesota 56542
Hibbing, Minnesota 55746
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218-786-3308
International Falls, Minnesota 56649
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218-283-9431
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55454
Monticello, Minnesota 55362
Moose Lake, Minnesota 55767
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218-485-4481
New Ulm, Minnesota 56073
Park Rapids, Minnesota 56470
Princeton, Minnesota 55371
Robbinsdale, Minnesota 55422
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Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Sandstone, Minnesota 55072
Shakopee, Minnesota 55379
Stillwater, Minnesota 55082
Virginia, Minnesota 55792
Waconia, Minnesota 55387
Willmar, Minnesota 56201
Woodbury, Minnesota 55125
Wyoming, Minnesota 55092
Ballwin, Missouri 63011
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314-251-7058
Bolivar, Missouri 65613
Branson, Missouri 65616
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417-269-4520
Cape Girardeau, Missouri 63703
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888-446-3729
Cape Girardeau, Missouri 63703
Farmington, Missouri 63640
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314-996-5569
Joplin, Missouri 64804
Joplin, Missouri 64804
Osage Beach, Missouri 65065
Rolla, Missouri 65401
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573-458-6379
Rolla, Missouri 65401
Saint Joseph, Missouri 64506
Saint Louis, Missouri 63109
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314-353-1870
Saint Louis, Missouri 63110
Saint Louis, Missouri 63128
Saint Louis, Missouri 63131
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314-996-5569
Saint Louis, Missouri 63141
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314-251-7066
Sainte Genevieve, Missouri 63670
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314-996-5569
Springfield, Missouri 65804
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417-269-4520
Springfield, Missouri 65807
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417-269-4520
Sullivan, Missouri 63080
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314-996-5569
Sunset Hills, Missouri 63127
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314-996-5569
Washington, Missouri 63090
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636-390-1600
Anaconda, Montana 59711
Billings, Montana 59101
Bozeman, Montana 59715
Great Falls, Montana 59405
Great Falls, Montana 59405
Havre, Montana 59501
Kalispell, Montana 59901
Missoula, Montana 59802
Missoula, Montana 59804
Grand Island, Nebraska 68803
Kearney, Nebraska 68847
Omaha, Nebraska 68114
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402-334-4773
Omaha, Nebraska 68114
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402-354-5144
Omaha, Nebraska 68114
Omaha, Nebraska 68122
Omaha, Nebraska 68124
Omaha, Nebraska 68130
Omaha, Nebraska 68131
Basking Ridge, New Jersey 07920
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212-639-7592
Camden, New Jersey 08103
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856-325-6757
Jersey City, New Jersey 07302
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Montvale, New Jersey 07645
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New Brunswick, New Jersey 08903
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732-235-7356
Sewell, New Jersey 08080
Albuquerque, New Mexico 87106
Buffalo, New York 14263
Commack, New York 11725
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Harrison, New York 10604
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Mineola, New York 11501
New York, New York 10016
New York, New York 10065
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Rochester, New York 14642
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585-275-5830
Syracuse, New York 13210
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315-464-5476
Uniondale, New York 11553
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212-639-7592
Chapel Hill, North Carolina 27599
Durham, North Carolina 27710
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888-275-3853
Raleigh, North Carolina 27607
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919-785-4878
Fargo, North Dakota 58103
Jamestown, North Dakota 58401
Athens, Ohio 45701
Beachwood, Ohio 44122
Chardon, Ohio 44024
Cincinnati, Ohio 45220
Cincinnati, Ohio 45242
Cincinnati, Ohio 45247
Cincinnati, Ohio 45255
Cleveland, Ohio 44106
Cleveland, Ohio 44111
Cleveland, Ohio 44195
Columbus, Ohio 43214
Columbus, Ohio 43214
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Columbus, Ohio 43228
Delaware, Ohio 43015
Delaware, Ohio 43015
Dublin, Ohio 43016
Dublin, Ohio 43016
Mansfield, Ohio 44903
Marion, Ohio 43302
Mayfield Heights, Ohio 44124
Mentor, Ohio 44060
Pickerington, Ohio 43147
Sylvania, Ohio 43560
Toledo, Ohio 43606
Westerville, Ohio 43082
Westlake, Ohio 44145
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73120
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405-752-3402
Baker City, Oregon 97814
Bend, Oregon 97701
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Newberg, Oregon 97132
Ontario, Oregon 97914
Oregon City, Oregon 97045
Portland, Oregon 97210
Portland, Oregon 97213
Portland, Oregon 97225
Portland, Oregon 97239
Redmond, Oregon 97756
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541-706-2909
Tualatin, Oregon 97062
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503-413-1742
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18104
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610-776-4714
Bethlehem, Pennsylvania 18015
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484-503-4151
Bethlehem, Pennsylvania 18017
Chadds Ford, Pennsylvania 19317
East Stroudsburg, Pennsylvania 18301
Easton, Pennsylvania 18045
Hazleton, Pennsylvania 18201
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19114
Quakertown, Pennsylvania 18951
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610-776-4714
Stroudsburg, Pennsylvania 18360
Willow Grove, Pennsylvania 19090
Providence, Rhode Island 02905
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401-274-1122
Aberdeen, South Dakota 57401
Pierre, South Dakota 57501
Yankton, South Dakota 57078
Houston, Texas 77030
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713-790-2700
Houston, Texas 77030
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713-792-3245
Houston, Texas 77070
Houston, Texas 77094
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832-522-2873
Nassau Bay, Texas 77058
The Woodlands, Texas 77385
Salt Lake City, Utah 84112
Charlottesville, Virginia 22908
Richmond, Virginia 23298
Aberdeen, Washington 98520
Bellingham, Washington 98225
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360-788-8223
Centralia, Washington 98531
Edmonds, Washington 98026
Everett, Washington 98201
Issaquah, Washington 98029
Kennewick, Washington 99336
Lacey, Washington 98503
Longview, Washington 98632
Mount Vernon, Washington 98274
Seattle, Washington 98107
Seattle, Washington 98122-5711
Seattle, Washington 98122
Sedro-Woolley, Washington 98284
Silverdale, Washington 98383
Vancouver, Washington 98686
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503-413-2150
Walla Walla, Washington 99362
Bridgeport, West Virginia 26330
Martinsburg, West Virginia 25401
Morgantown, West Virginia 26506
Parkersburg, West Virginia 26101
Princeton, West Virginia 24740
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304-487-7515
Wheeling, West Virginia 26003
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304-243-6442
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
Hayward, Wisconsin 54843
Milwaukee, Wisconsin 53226
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414-805-3666
Mukwonago, Wisconsin 53149
New Richmond, Wisconsin 54017
Oconomowoc, Wisconsin 53066
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262-928-7878
Oconto Falls, Wisconsin 54154
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Spooner, Wisconsin 54801
Sturgeon Bay, Wisconsin 54235-1495
Superior, Wisconsin 54880
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701-364-6272
Waukesha, Wisconsin 53188
Site Public Contact
262-928-7632
Waukesha, Wisconsin 53188
Cody, Wyoming 82414
More Details
- NCT ID
- NCT06580314
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed Description
PRIMARY OBJECTIVE: I. To determine investigator assessed progression-free survival using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (non-inferiority) for one versus (vs.) two years of maintenance olaparib. SECONDARY OBJECTIVES: I. To evaluate overall survival (OS360) in the modified intent to treat (ITT) population, with time at risk for progression/death starting 360 days after randomization. II. To evaluate progression-free survival (PFS), PFS2 and overall survival (OS) in the ITT population. III. To evaluate PFS, PFS2, and OS in the as-treated population. IV. To evaluate toxicity, including rates of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and other secondary malignancies, in the safety population. EXPLORATORY OBJECTIVE: I. To evaluate the moderating effect of physician-choice bevacizumab (as stratified) on randomized treatment effect estimates. TRANSLATIONAL OBJECTIVES: I. To assess BRCA reversion mutations in circulating tumor deoxyribonucleic acid (ctDNA) as a predictor of poor response in the BRCA mutated (BRCAm) population. II. To correlate a combined assay assessing quantitative BRCA1 and RAD51C promoter methylation and pathogenic variants in core homologous recombination repair (HRR) genes with clinical homologous recombination deficiency (HRD) testing and outcomes in the BRCA wildtype (BRCAwt) population. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (REFERENCE): Patients receive olaparib orally (PO) twice daily (BID) on days 1-21 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study. ARM II (EXPERIMENTAL): Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT and/or MRI throughout the study. After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years.