Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.



Status:Active, not recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 127
Updated:3/27/2019
Start Date:August 26, 2013
End Date:June 6, 2023

Use our guide to learn which trials are right for you!

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.

Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line
Platinum Based Chemotherapy.

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib
Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian
Cancer following First Line Platinum Based Chemotherapy.

Inclusion Criteria:

- Female patients with newly diagnosed, histologically confirmed, high risk advanced
(FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid
ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have
completed first line platinum based chemotherapy (intravenous or intraperitoneal).

- Stage III patients must have had one attempt at optimal debulking surgery (upfront or
interval debulking). Stage IV patients must have had either a biopsy and/or upfront or
interval debulking surgery.

- Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected
deleterious (known or predicted to be detrimental/lead to loss of function).

- Patients who have completed first line platinum (e.g. carboplatin or cisplatin),
containing therapy (intravenous or intraperitoneal) prior to randomisation:

- Patients must have, in the opinion of the investigator, clinical complete response or
partial response and have no clinical evidence of disease progression on the post
treatment scan or rising CA-125 level, following completion of this chemotherapy
course. Patients with stable disease on the post-treatment scan at completion of first
line platinum-containing therapy are not eligible for the study.

- Patients must be randomized within 8 weeks of their last dose of chemotherapy

Exclusion Criteria:

- BRCA1 and/or BRCA2 mutations that are considered to be non detrimental (e.g. "Variants
of uncertain clinical significance" or "Variant of unknown significance" or "Variant,
favor polymorphism" or "benign polymorphism" etc).

- Patients with early stage disease (FIGO Stage I, IIA, IIB or IIC)

- Stable disease or progressive disease on the post-treatment scan or clinical evidence
of progression at the end of the patient's first line chemotherapy treatment.

- Patients where more than one debulking surgery has been performed before randomisation
to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable
and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and
interval debulking surgery are eligible).

- Patients who have previously been diagnosed and treated for earlier stage ovarian,
fallopian tube or primary peritoneal cancer.

- Patients who have previously received chemotherapy for any abdominal or pelvic tumour,
including treatment for prior diagnosis at an earlier stage for their ovarian,
fallopian tube or primary peritoneal cancer. (Patients who have received prior
adjuvant chemotherapy for localised breast cancer may be eligible, provided that it
was completed more than three years prior to registration, and that the patient
remains free of recurrent or metastatic disease).

- Patients with synchronous primary endometrial cancer unless both of the following
criteria are met: 1) stage <2 2) less than 60 years old at the time of diagnosis of
endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid
adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with
Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell
adenocarcinoma or carcinosarcoma of the endometrium are not eligible.
We found this trial at
82
sites
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
?
mi
from
Columbia, SC
Click here to add this to my saved trials
2500 Campus Rd
Honolulu, Hawaii 96822
(808) 956-8111
Univ of Hawaii Honolulu Community College is an integral part of the University of Hawai?i,...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
?
mi
from
Abington, PA
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
?
mi
from
Ames, IA
Click here to add this to my saved trials
Anchorage, Alaska 99508
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Asheville, North Carolina
?
mi
from
Asheville, NC
Click here to add this to my saved trials
1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21218
(410) 516-8000
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Bethlehem, Pennsylvania
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Camden, NJ
Click here to add this to my saved trials
Canton, Ohio 44710
?
mi
from
Canton, OH
Click here to add this to my saved trials
CHapel Hill, North Carolina 27599
?
mi
from
CHapel Hill, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
Cleveland Clinic Cancer Center at Fairview Hospital Fairview Hospital is a 488-bed hospital located at...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Edina, Minnesota 55435
?
mi
from
Edina, MN
Click here to add this to my saved trials
Fargo, North Dakota 58122
?
mi
from
Fargo, ND
Click here to add this to my saved trials
263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
?
mi
from
Farmington, CT
Click here to add this to my saved trials
743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
Grand Rapids, Michigan
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
2845 Greenbrier Rd
Green Bay, Wisconsin 54311
(920) 288-8000
Aurora BayCare Medical Center Aurora BayCare Medical Center is a 167-bed, full-service hospital serving the...
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
Hackensack, New Jersey 07601
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
?
mi
from
Heidelberg,
Click here to add this to my saved trials
1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35805
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
?
mi
from
Kettering, OH
Click here to add this to my saved trials
3131 La Canada St # 241
Las Vegas, Nevada 89169
(702) 693-6870
Women's Cancer Center of Nevada The Women's Cancer Center is a recognized leader in the...
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Louisville, Kentucky
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Madison, Wisconsin 53706
(608) 263-2400
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
?
mi
from
Madison, WI
Click here to add this to my saved trials
Mayfield Heights, Ohio 44124
?
mi
from
Mayfield Heights, OH
Click here to add this to my saved trials
Milwaukee, Wisconsin
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Mishawaka, IN
Click here to add this to my saved trials
New Haven, Connecticut 06520
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York
?
mi
from
New York, NY
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oakland, California 94612
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
6818 Grover Street #200
Omaha, Nebraska 68106
(402) 991-8070
Missouri Valley Cancer Consortium CCOP Founded in 1993, the Missouri Valley Cancer Consortium (MVCC) is...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orlando, Florida
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32804
?
mi
from
Orlando, FL
Click here to add this to my saved trials
1775 West Dempster Street
Park Ridge, Illinois 60068
(847) 723-2210
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Providence, Rhode Island 02905
?
mi
from
Providence, RI
Click here to add this to my saved trials
Roanoke, Virginia 24016
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Roseville, California
?
mi
from
Roseville, CA
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Scarborough, Maine 04074
?
mi
from
Scarborough, ME
Click here to add this to my saved trials
Sioux Falls, South Dakota 57105
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Stanford, California
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Walnut Creek, California
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials