Phase
Condition
N/ATreatment
Olaparib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For all participants:
Has measurable disease per RECIST 1.1 or PCWG-modified RECIST 1.1 as assessed by thelocal site Investigator/radiology and confirmed by BICR.
Is able to provide a newly obtained core or excisional biopsy of a tumor lesion oreither an archival formalin-fixed paraffin embedded (FFPE) tumor tissue block orslides.
Has a life expectancy of at least 3 months.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 7 days of treatment initiation.
Male participants must agree to use contraception during the treatment period andfor at least 95 days (3 months and 5 days) after the last dose of study treatmentand refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant orbreastfeeding, and at least one of the following conditions applies:
Is not a woman of childbearing potential (WOCBP).
Is a WOCBP and using a contraceptive method that is highly effective with lowuser dependency, or be abstinent from heterosexual intercourse as theirpreferred and usual lifestyle (abstinent on a long term and persistent basis),during the intervention period and for at least 180 days after the last dose ofstudy intervention, AND agrees not to donate eggs (ova, oocytes) to others orfreeze/store for her own use for the purpose of reproduction during thisperiod. Abstains from breastfeeding during the study intervention period andfor at least 30 days after the last dose of study intervention.
Has adequate organ function.
For participants who have non-breast or -ovarian cancers that are breast cancersusceptibility gene 1/2 (BRCA1/2) mutated (BRCAm), or who have cancers that areBRCA1/2 non-mutated and homologous recombination repair nonmutated:
Has a histologically- or cytologically-confirmed advanced (metastatic and/orunresectable) solid tumor (except ovarian cancer whose tumor has a germline orsomatic BRCA mutation and breast cancer whose tumor has a germline BRCA mutation)that is not eligible for curative treatment and for which standard of care therapyhas failed. Participants must have progressed on or be intolerant to standard ofcare therapies that are known to provide clinical benefit. There is no limit on thenumber of prior treatment regimens.
Has either centrally-confirmed known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally-confirmed HRD.
For participants receiving prior platinum (cisplatin, carboplatin, or oxaliplatineither as monotherapy or in combination) for advanced (metastatic and/orunresectable) solid tumor, have no evidence of disease progression during theplatinum chemotherapy or ≤4 weeks of completing the platinum-containing regimen.
For participants who have somatic BRCAm breast cancer:
Has histologically- or cytologically-confirmed breast cancer with evidence ofmetastatic disease.
Has a known or suspected deleterious mutation in breast cancer susceptibility gene (BRCA) 1 or BRCA2 and does not harbor a germline BRCA1 or BRCA2 mutation - testingcan be done centrally or locally. Blood and tissue samples must be provided by allparticipants.
Has received treatment with an anthracycline unless contraindicated and a taxane ineither the neoadjuvant/adjuvant or metastatic setting.
Participants with estrogen and/or progesterone receptor-positive disease must havereceived and progressed on at least one endocrine therapy (adjuvant or metastatic),or have disease that the treating physician believes to be inappropriate forendocrine therapy.
Exclusion
Exclusion Criteria:
Has a known additional malignancy that is progressing or has required activetreatment in the last 5 years. Note: Participants with basal cell carcinoma of theskin, squamous cell carcinoma of the skin, ductal carcinoma in situ, or cervicalcarcinoma in situ that has undergone potentially curative therapy are not excluded.
Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with featuressuggestive of MDS/AML.
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.Note: Participants with previously treated brain metastases may participate ifradiologically stable, clinically stable, and without requirement for steroidtreatment for at least 14 days prior to the first dose of study treatment.
Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinanterythropoietin) within 28 days prior to the first dose of study treatment.
Has a known history of human immunodeficiency virus (HIV) infection.
Has known active hepatitis infection (i.e., Hepatitis B or C).
Is unable to swallow orally administered medication or has a gastrointestinaldisorder affecting absorption (e.g., gastrectomy, partial bowel obstruction,malabsorption).
Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (poly[ADP ribose]) polymerization (PARP) inhibitor.
Has a known hypersensitivity to the components or excipients in olaparib.
Has received previous allogenic bone-marrow transplant or double umbilical cordtransplantation (dUCBT).
Has received a whole blood transfusion in the last 120 days prior to entry to thestudy. Packed red blood cells and platelet transfusions are acceptable if notperformed within 28 days of the first dose of study treatment.
Has received any anti-neoplastic systemic chemotherapy or biological therapy,targeted therapy, or an anticancer hormonal therapy within 3 weeks prior to thefirst dose of study intervention.
Has a primary cancer of unknown origin.
Has received prior radiotherapy within 2 weeks of start of study intervention.Participants must have recovered from all radiation-related toxicities, not requirecorticosteroids, and not have had radiation pneumonitis. A 1-week washout ispermitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Study Design
Connect with a study center
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703)
Berazategui, Buenos Aires B1884BBF
ArgentinaSite Not Available
Hospital Britanico de Buenos Aires ( Site 2704)
Ciudad de Buenos Aires, Caba C1280AEB
ArgentinaSite Not Available
Hospital Aleman ( Site 2702)
Buenos Aires, C1118AAT
ArgentinaSite Not Available
Instituto de Investigaciones Metabolicas ( Site 2700)
Buenos Aires, C1012AAR
ArgentinaSite Not Available
CEMEDIC - Centro de Especialidades Medicas ( Site 2700)
Ciudad Autonoma de Buenos Aires, C1407GTN
ArgentinaSite Not Available
Kinghorn Cancer Centre ( Site 2200)
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
MNCCI Port Macquarie Base Hospital ( Site 2201)
Port Macquarie, New South Wales 2444
AustraliaSite Not Available
Linear Clinical Research Ltd ( Site 2202)
Nedlands, Western Australia 6009
AustraliaSite Not Available
Sunnybrook Research Institute ( Site 0210)
Toronto, Ontario M4N 3M5
CanadaSite Not Available
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203)
Montreal, Quebec H1T 2M4
CanadaSite Not Available
Jewish General Hospital ( Site 0209)
Montreal, Quebec H3T 1E2
CanadaSite Not Available
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Quebec City, Quebec G1J 1Z4
CanadaSite Not Available
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Quebec, G1J 1Z4
CanadaSite Not Available
Fundacion Centro de Investigacion Clinica CIC ( Site 2812)
Medellin, Antioquia 050021
ColombiaSite Not Available
Rodrigo Botero SAS ( Site 2801)
Medellin, Antioquia 050030
ColombiaSite Not Available
Biomelab S A S ( Site 2800)
Barranquilla, Atlantico 080001
ColombiaSite Not Available
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2808)
Valledupar, Cesar 200001
ColombiaSite Not Available
Oncomedica S.A. ( Site 2806)
Monteria, Cordoba 230002
ColombiaSite Not Available
Administradora Country SA - Clinica del Country ( Site 2802)
Bogota, Distrito Capital De Bogota 110221
ColombiaSite Not Available
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2807)
Bogota, Distrito Capital De Bogota 110311
ColombiaSite Not Available
Instituto Nacional de Cancerologia E.S.E ( Site 2809)
Bogota, Distrito Capital De Bogota 111511
ColombiaSite Not Available
C. Medico Imbanaco Cali S.A. ( Site 2810)
Cali, Valle Del Cauca 760042
ColombiaSite Not Available
Rigshospitalet ( Site 0402)
Copenhagen, Hovedstaden 2100
DenmarkSite Not Available
Herlev og Gentofte Hospital. ( Site 0401)
Herlev, Hovedstaden 2730
DenmarkSite Not Available
Odense Universitetshospital ( Site 0400)
Odense, Syddanmark 5000
DenmarkSite Not Available
CHU Poitiers ( Site 0612)
Poitiers, Ain 86021
FranceSite Not Available
Centre Antoine Lacassagne ( Site 0610)
Nice, Alpes-Maritimes 06189
FranceSite Not Available
Institut de Cancerologie Strasbourg Europe ( Site 0613)
Strasbourg, Alsace 67033
FranceSite Not Available
Centre Georges Francois Leclerc ( Site 0608)
Dijon, Bourgogne 21000
FranceSite Not Available
Institut Bergonie ( Site 0603)
Bordeaux, Gironde 33076
FranceSite Not Available
Institut Gustave Roussy ( Site 0601)
Villejuif, Val-de-Marne 94805
FranceSite Not Available
Centro Regional de Sub Especialidades Medicas SA ( Site 3003)
Guatemala, Quetzaltenango 09001
GuatemalaSite Not Available
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 3004)
Guatemala, 01010
GuatemalaSite Not Available
Grupo Angeles SA ( Site 3001)
Guatemala, 01015
GuatemalaSite Not Available
Integra Cancer Institute ( Site 3006)
Guatemala, 01010
GuatemalaSite Not Available
Centro Regional de Sub Especialidades Medicas SA ( Site 3003)
Quetzaltenango, 09001
GuatemalaSite Not Available
Mater Misericordiae University Hospital ( Site 1654)
Dublin, Carlow D07 WKW8
IrelandSite Not Available
Bon Secours Hospital ( Site 1656)
Cork, T12 DV56
IrelandSite Not Available
St. Vincent's University Hospital ( Site 1653)
Dublin, 00004
IrelandSite Not Available
Tallaght University Hospital ( Site 1652)
Dublin, D24 NROA
IrelandSite Not Available
Soroka Medical Center ( Site 0800)
Beer-Sheva, 8457108
IsraelSite Not Available
Rambam Health Care Campus-Oncology Division ( Site 0801)
Haifa, 3109601
IsraelSite Not Available
Hadassah Ein Kerem Medical Center ( Site 0802)
Jerusalem, 9112001
IsraelSite Not Available
Chaim Sheba Medical Center ( Site 0803)
Ramat Gan, 5262000
IsraelSite Not Available
Sourasky Medical Center ( Site 0804)
Tel Aviv, 6423906
IsraelSite Not Available
Istituto Nazionale Tumori Fondazione Pascale ( Site 0700)
Napoli, Campania 80131
ItalySite Not Available
Istituto Clinico Humanitas Research Hospital ( Site 0703)
Rozzano, Lombardia 20089
ItalySite Not Available
Policlinico Le Scotte di Siena ( Site 0704)
Siena, Toscana 53100
ItalySite Not Available
Aichi Cancer Center Hospital ( Site 2602)
Nagoya, Aichi 464-8681
JapanSite Not Available
National Cancer Center Hospital East ( Site 2600)
Kashiwa, Chiba 2778577
JapanSite Not Available
Kyoto University Hospital ( Site 2603)
Kyoto-shi, Kyoto 606-8507
JapanSite Not Available
Osaka University Hospital ( Site 2604)
Suita, Osaka 565-0871
JapanSite Not Available
Kyoto University Hospital ( Site 2603)
Kyoto, 606-8507
JapanSite Not Available
National Cancer Center Hospital ( Site 2601)
Tokyo, 104-0045
JapanSite Not Available
The Cancer Institute Hospital of JFCR ( Site 2605)
Tokyo, 135-8550
JapanSite Not Available
Seoul National University Bundang Hospital ( Site 2402)
Seongnam-si, Kyonggi-do 13620
Korea, Republic ofSite Not Available
Seoul National University Hospital ( Site 2401)
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System ( Site 2400)
Seoul, 03722
Korea, Republic ofSite Not Available
Actualidad Basada en la Investigacion del Cancer ( Site 2903)
Guadalajara, Jalisco 44680
MexicoSite Not Available
Unidad Biomedica Avanzada Monterrey S. A. ( Site 2902)
Monterrey, Nuevo Leon 64460
MexicoSite Not Available
Cuidados Oncologicos ( Site 2908)
Santiago De Quetaro, Queretaro 76000
MexicoSite Not Available
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2901)
Madero, Tamaulipas 89440
MexicoSite Not Available
Centro Estatal de Cancerologia de Chihuahua ( Site 2907)
Chihuahua, 31000
MexicoSite Not Available
CENEIT Oncologicos ( Site 2904)
Mexico, 03100
MexicoSite Not Available
CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 2900)
Mexico City, 06100
MexicoSite Not Available
Oaxaca Site Management Organization S.C. ( Site 2905)
Oaxaca, 68000
MexicoSite Not Available
Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 3102)
Trujillo, La Libertad 13006
PeruSite Not Available
Instituto Nacional de Enfermedades Neoplasicas ( Site 3106)
Lima, Muni Metro De Lima 15038
PeruSite Not Available
Clinica Internacional Sede San Borja ( Site 3100)
Lima, 15036
PeruSite Not Available
Hospital Arzobispo Loayza ( Site 3103)
Lima, 15082
PeruSite Not Available
Hospital Central de la Fuerza Aerea del Peru ( Site 3104)
Lima, 15046
PeruSite Not Available
Hospital Militar Central Coronel Luis Arias Schereiber ( Site 3105)
Lima, 15076
PeruSite Not Available
Hospital Nacional Guillermo Almenara Irigoyen ( Site 3107)
Lima, 15033
PeruSite Not Available
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 3101)
Lima, 15036
PeruSite Not Available
Oncosalud-Clinical Research ( Site 3108)
Lima, 15036
PeruSite Not Available
S.C. Pelican Impex S.R.L Spitalul Clinic Pelican Oradea ( Site 1102)
Oradea, Bihor 410469
RomaniaSite Not Available
Medisprof ( Site 1107)
Cluj Napoca, Cluj 400641
RomaniaSite Not Available
SC Radiotherapy Center Cluj SRL ( Site 1105)
Comuna Floresti, Cluj 407280
RomaniaSite Not Available
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)
Craiova, Dolj 200542
RomaniaSite Not Available
Spitalul PDR Medlife ( Site 1106)
Brasov, 500152
RomaniaSite Not Available
S.C.Focus Lab Plus S.R.L ( Site 1101)
Bucuresti, 022548
RomaniaSite Not Available
S.C.Gral Medical S.R.L ( Site 1104)
Bucuresti, 031422
RomaniaSite Not Available
Arkhangelsk Clinical Oncological Dispensary ( Site 1204)
Arkhangelsk, Arkhangel Skaya Oblast 163045
Russian FederationSite Not Available
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1212)
Chelyabinsk, Chelyabinskaya Oblast 454087
Russian FederationSite Not Available
MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1216)
Krasnogorsk, Moskovskaya Oblast 143442
Russian FederationSite Not Available
MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1213)
Moscow, Moskva 125284
Russian FederationSite Not Available
N.N. Blokhin NMRCO ( Site 1201)
Moscow, Moskva 115477
Russian FederationSite Not Available
Ryazan Regional Clinical Oncology dispensary ( Site 1202)
Ryazan, Ryazanskaya Oblast 390011
Russian FederationSite Not Available
SBHI Samara Regional Clinical Oncology Dispensary ( Site 1211)
Samara, Samarskaya Oblast 443031
Russian FederationSite Not Available
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1208)
Saint Petersburg, Sankt-Peterburg 197758
Russian FederationSite Not Available
Clinical Hospital Saint Luka ( Site 1205)
Saint-Petersburg, Sankt-Peterburg 194044
Russian FederationSite Not Available
SBHI Leningrad Regional Clinical Hospital ( Site 1206)
St.Petersburg, Sankt-Peterburg 194291
Russian FederationSite Not Available
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1207)
Kazan, Tatarstan, Respublika 420029
Russian FederationSuspended
Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 120
Kazan, Tatarstan, Respublika 420029
Russian FederationSite Not Available
Hospital Universitario Quiron Madrid ( Site 1352)
Pozuelo de Alarcon, Madrid 28223
SpainSite Not Available
Hospital Universitari Vall d Hebron ( Site 1350)
Barcelona, 08035
SpainSite Not Available
Universitaetsspital Zuerich ( Site 1400)
Zuerich, Aargau 8091
SwitzerlandSite Not Available
Hopitaux Universitaires de Geneve HUG. ( Site 1406)
Geneva, Geneve 1211
SwitzerlandSite Not Available
Ospedale Regionale di Bellinzona e Valli ( Site 1407)
Bellinzona, Ticino 6500
SwitzerlandSite Not Available
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507)
Konya, Adana 42080
TurkeySite Not Available
Baskent University Adana Training Hospital ( Site 1508)
Adana, 01250
TurkeySite Not Available
Hacettepe Universitesi Tıp Fakultesi ( Site 1503)
Ankara, 06100
TurkeySite Not Available
Akdeniz Universitesi Tip Fakultesi ( Site 1504)
Antalya, 07070
TurkeySite Not Available
Trakya Universitesi Tip Fakultesi ( Site 1500)
Edirne, 22030
TurkeySite Not Available
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1506)
Istanbul, 34722
TurkeySite Not Available
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1505)
Istanbul, 34098
TurkeySite Not Available
Ege Universitesi Tip Fakultesi ( Site 1502)
Izmir, 35100
TurkeySite Not Available
Churchill Hospital ( Site 1606)
Oxford, Worcestershire OX3 7LE
United KingdomSite Not Available
Christie NHS Foundation Trust ( Site 1601)
Manchester, M20 4BX
United KingdomSite Not Available
Northern Centre for Cancer Care ( Site 1602)
Newcastle Upon Tyne, NE7 7DN
United KingdomSite Not Available
Northern Centre for Cancer Care ( Site 1602)
Newcastle upon Tyne, NE7 7DN
United KingdomActive - Recruiting
Northern Centre for Cancer Care ( Site 1602)
Newcastle-upon-Tyne, NE7 7DN
United KingdomSite Not Available
Weston Park Hospital ( Site 1607)
Sheffield, S10 2SJ
United KingdomSite Not Available
The University of Arizona Cancer Center - North Campus ( Site 0011)
Tucson, Arizona 85719
United StatesSite Not Available
St Joseph Heritage Healthcare-Oncology ( Site 0056)
Fullerton, California 92835
United StatesSite Not Available
Cedars Sinai Medical Center ( Site 0002)
Los Angeles, California 90048
United StatesSite Not Available
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)
San Francisco, California 94158
United StatesSite Not Available
Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092)
Aurora, Colorado 80045
United StatesSite Not Available
Winship Cancer Institute of Emory University ( Site 0025)
Atlanta, Georgia 30322-1013
United StatesSite Not Available
Augusta University ( Site 0028)
Augusta, Georgia 30912
United StatesSite Not Available
Markey Cancer Center ( Site 0018)
Lexington, Kentucky 40536
United StatesSite Not Available
University of Maryland ( Site 0050)
Baltimore, Maryland 21201
United StatesSite Not Available
Weinberg Cancer Institute at Franklin Square ( Site 0054)
Baltimore, Maryland 21237
United StatesSite Not Available
University of Massachusetts ( Site 0017)
Worcester, Massachusetts 01655
United StatesSite Not Available
Henry Ford Health System ( Site 0060)
Detroit, Michigan 48202
United StatesSite Not Available
Cancer Partners of Nebraska ( Site 0051)
Lincoln, Nebraska 68510
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116)
Middletown, New Jersey 07748
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126)
Harrison, New York 10604
United StatesSite Not Available
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057)
New York, New York 10016
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center ( Site 0026)
New York, New York 10065
United StatesSite Not Available
VA New York Harbor Healthcare System Manhattan ( Site 0094)
New York, New York 10010
United StatesSite Not Available
Southwestern Regional Medical Center, Inc. ( Site 0079)
Tulsa, Oklahoma 74133
United StatesSite Not Available
Eastern Regional Medical Center, Inc. ( Site 0077)
Philadelphia, Pennsylvania 19124
United StatesSite Not Available
Sanford Hematology Oncology-Sioux Falls SD ( Site 0012)
Sioux Falls, South Dakota 57104
United StatesSite Not Available
Intermountain Healthcare ( Site 0043)
Saint George, Utah 84790
United StatesSite Not Available
Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093)
Seattle, Washington 98108
United StatesSite Not Available
Virginia Mason Medical Center ( Site 0052)
Seattle, Washington 98101
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.