Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)
NCT ID: NCT03742895
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
390 participants
INTERVENTIONAL
2018-12-12
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Olaparib
Participants with HRRm or HRD-positive advanced cancer will receive oral olaparib, 300 mg twice daily (BID).
Olaparib
Olaparib 300 mg administered BID as two, 150 mg oral tablets.
Interventions
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Olaparib
Olaparib 300 mg administered BID as two, 150 mg oral tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has measurable disease per RECIST 1.1 or PCWG-modified RECIST 1.1 as assessed by the local site Investigator/radiology and confirmed by BICR.
* Is able to provide a newly obtained core or excisional biopsy of a tumor lesion or either an archival formalin-fixed paraffin embedded (FFPE) tumor tissue block or slides.
* 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 and for at least 95 days (3 months and 5 days) after the last dose of study treatment and refrain from donating sperm during this period.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
1. Is not a woman of childbearing potential (WOCBP).
2. Is a WOCBP and using a contraceptive method that is highly effective with low user dependency, or be abstinent from heterosexual intercourse as their preferred 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 of study intervention, AND agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. Abstains from breastfeeding during the study intervention period and for 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 cancer susceptibility gene 1/2 (BRCA1/2) mutated (BRCAm), or who have cancers that are BRCA1/2 non-mutated and homologous recombination repair nonmutated:
* Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor (except ovarian cancer whose tumor has a germline or somatic 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 therapy has failed. Participants must have progressed on or be intolerant to standard of care therapies that are known to provide clinical benefit. There is no limit on the number 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 oxaliplatin either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor, have no evidence of disease progression during the platinum 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 of metastatic 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 - testing can be done centrally or locally. Blood and tissue samples must be provided by all participants.
* Has received treatment with an anthracycline unless contraindicated and a taxane in either the neoadjuvant/adjuvant or metastatic setting.
* Participants with estrogen and/or progesterone receptor-positive disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
Exclusion Criteria
* Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
* Has known central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Participants with previously treated brain metastases may participate if radiologically stable, clinically stable, and without requirement for steroid treatment 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 recombinant erythropoietin) 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 gastrointestinal disorder 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 cord transplantation (dUCBT).
* Has received a whole blood transfusion in the last 120 days prior to entry to the study. Packed red blood cells and platelet transfusions are acceptable if not performed 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 the first 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 require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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The University of Arizona Cancer Center - North Campus ( Site 0011)
Tucson, Arizona, United States
St Joseph Heritage Healthcare-Oncology ( Site 0056)
Fullerton, California, United States
Cedars Sinai Medical Center ( Site 0002)
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)
San Francisco, California, United States
Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092)
Aurora, Colorado, United States
Winship Cancer Institute of Emory University ( Site 0025)
Atlanta, Georgia, United States
Augusta University ( Site 0028)
Augusta, Georgia, United States
Markey Cancer Center ( Site 0018)
Lexington, Kentucky, United States
University of Maryland ( Site 0050)
Baltimore, Maryland, United States
Weinberg Cancer Institute at Franklin Square ( Site 0054)
Baltimore, Maryland, United States
University of Massachusetts ( Site 0017)
Worcester, Massachusetts, United States
Henry Ford Health System ( Site 0060)
Detroit, Michigan, United States
Cancer Partners of Nebraska ( Site 0051)
Lincoln, Nebraska, United States
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116)
Middletown, New Jersey, United States
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126)
Harrison, New York, United States
VA New York Harbor Healthcare System Manhattan ( Site 0094)
New York, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057)
New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0026)
New York, New York, United States
Southwestern Regional Medical Center, Inc. ( Site 0079)
Tulsa, Oklahoma, United States
Eastern Regional Medical Center, Inc. ( Site 0077)
Philadelphia, Pennsylvania, United States
Sanford Hematology Oncology-Sioux Falls SD ( Site 0012)
Sioux Falls, South Dakota, United States
Intermountain Healthcare ( Site 0043)
St. George, Utah, United States
Virginia Mason Medical Center ( Site 0052)
Seattle, Washington, United States
Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093)
Seattle, Washington, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703)
Berazategui, Buenos Aires, Argentina
Hospital Britanico de Buenos Aires ( Site 2704)
Ciudad de Buenos Aires, Buenos Aires F.D., Argentina
Instituto de Investigaciones Metabolicas ( Site 2700)
Buenos Aires, , Argentina
Hospital Aleman ( Site 2702)
Buenos Aires, , Argentina
Kinghorn Cancer Centre ( Site 2200)
Darlinghurst, New South Wales, Australia
MNCCI Port Macquarie Base Hospital ( Site 2201)
Port Macquarie, New South Wales, Australia
Linear Clinical Research Ltd ( Site 2202)
Nedlands, Western Australia, Australia
Sunnybrook Research Institute ( Site 0210)
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203)
Montreal, Quebec, Canada
Jewish General Hospital ( Site 0209)
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Québec, Quebec, Canada
Fundacion Centro de Investigacion Clinica CIC ( Site 2812)
Medellín, Antioquia, Colombia
Rodrigo Botero SAS ( Site 2801)
Medellín, Antioquia, Colombia
Biomelab S A S ( Site 2800)
Barranquilla, Atlántico, Colombia
Administradora Country SA - Clinica del Country ( Site 2802)
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2807)
Bogotá, Bogota D.C., Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 2809)
Bogotá, Bogota D.C., Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2808)
Valledupar, Cesar Department, Colombia
Oncomedica S.A. ( Site 2806)
Montería, Departamento de Córdoba, Colombia
C. Medico Imbanaco Cali S.A. ( Site 2810)
Cali, Valle del Cauca Department, Colombia
Rigshospitalet ( Site 0402)
Copenhagen, Capital Region, Denmark
Herlev og Gentofte Hospital. ( Site 0401)
Herlev, Capital Region, Denmark
Odense Universitetshospital ( Site 0400)
Odense, Region Syddanmark, Denmark
CHU Poitiers ( Site 0612)
Poitiers, Ain, France
Centre Antoine Lacassagne ( Site 0610)
Nice, Alpes-Maritimes, France
Institut de Cancerologie Strasbourg Europe ( Site 0613)
Strasbourg, Alsace, France
Centre Georges Francois Leclerc ( Site 0608)
Dijon, Bourgogne-Franche-Comté, France
Institut Bergonie ( Site 0603)
Bordeaux, Gironde, France
Institut Gustave Roussy ( Site 0601)
Villejuif, Val-de-Marne, France
Centro Regional de Sub Especialidades Medicas SA ( Site 3003)
Guatemala, Departamento de Quetzaltenango, Guatemala
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 3004)
Guatemala City, , Guatemala
Integra Cancer Institute ( Site 3006)
Guatemala City, , Guatemala
Grupo Angeles SA ( Site 3001)
Guatemala City, , Guatemala
Mater Misericordiae University Hospital ( Site 1654)
Dublin, Carlow, Ireland
Bon Secours Hospital ( Site 1656)
Cork, , Ireland
St. Vincent's University Hospital ( Site 1653)
Dublin, , Ireland
Tallaght University Hospital ( Site 1652)
Dublin, , Ireland
Soroka Medical Center ( Site 0800)
Beersheba, , Israel
Rambam Health Care Campus-Oncology Division ( Site 0801)
Haifa, , Israel
Hadassah Ein Kerem Medical Center ( Site 0802)
Jerusalem, , Israel
Chaim Sheba Medical Center ( Site 0803)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 0804)
Tel Aviv, , Israel
Istituto Nazionale Tumori Fondazione Pascale ( Site 0700)
Napoli, Campania, Italy
Istituto Clinico Humanitas Research Hospital ( Site 0703)
Rozzano, Lombardy, Italy
Policlinico Le Scotte di Siena ( Site 0704)
Siena, Tuscany, Italy
Aichi Cancer Center Hospital ( Site 2602)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 2600)
Kashiwa, Chiba, Japan
Kyoto University Hospital ( Site 2603)
Kyoto, Kyoto, Japan
Osaka University Hospital ( Site 2604)
Suita, Osaka, Japan
National Cancer Center Hospital ( Site 2601)
Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 2605)
Tokyo, , Japan
Actualidad Basada en la Investigacion del Cancer ( Site 2903)
Guadalajara, Jalisco, Mexico
Unidad Biomedica Avanzada Monterrey S. A. ( Site 2902)
Monterrey, Nuevo León, Mexico
Cuidados Oncologicos ( Site 2908)
Santiago de Quetaro, Querétaro, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2901)
Madero, Tamaulipas, Mexico
Centro Estatal de Cancerologia de Chihuahua ( Site 2907)
Chihuahua City, , Mexico
CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 2900)
Mexico City, , Mexico
CENEIT Oncologicos ( Site 2904)
México, , Mexico
Oaxaca Site Management Organization S.C. ( Site 2905)
Oaxaca City, , Mexico
Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 3102)
Trujillo, La Libertad, Peru
Instituto Nacional de Enfermedades Neoplasicas ( Site 3106)
Lima, Muni Metro de Lima, Peru
Hospital Nacional Guillermo Almenara Irigoyen ( Site 3107)
Lima, , Peru
Clinica Internacional Sede San Borja ( Site 3100)
Lima, , Peru
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 3101)
Lima, , Peru
Oncosalud-Clinical Research ( Site 3108)
Lima, , Peru
Hospital Central de la Fuerza Aerea del Peru ( Site 3104)
Lima, , Peru
Hospital Militar Central Coronel Luis Arias Schereiber ( Site 3105)
Lima, , Peru
Hospital Arzobispo Loayza ( Site 3103)
Lima, , Peru
S.C. Pelican Impex S.R.L Spitalul Clinic Pelican Oradea ( Site 1102)
Oradea, Bihor County, Romania
Medisprof ( Site 1107)
Cluj-Napoca, Cluj, Romania
SC Radiotherapy Center Cluj SRL ( Site 1105)
Comuna Floresti, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)
Craiova, Dolj, Romania
Spitalul PDR Medlife ( Site 1106)
Brasov, , Romania
S.C.Focus Lab Plus S.R.L ( Site 1101)
Bucharest, , Romania
S.C.Gral Medical S.R.L ( Site 1104)
Bucharest, , Romania
Arkhangelsk Clinical Oncological Dispensary ( Site 1204)
Arkhangelsk, Arkhangelskaya oblast, Russia
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1212)
Chelyabinsk, Chelyabinsk Oblast, Russia
N.N. Blokhin NMRCO ( Site 1201)
Moscow, Moscow, Russia
MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1213)
Moscow, Moscow, Russia
MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1216)
Krasnogorsk, Moscow Oblast, Russia
Ryazan Regional Clinical Oncology dispensary ( Site 1202)
Ryazan, Ryazan Oblast, Russia
SBHI Samara Regional Clinical Oncology Dispensary ( Site 1211)
Samara, Samara Oblast, Russia
Clinical Hospital Saint Luka ( Site 1205)
Saint Petersburg, Sankt-Peterburg, Russia
SBHI Leningrad Regional Clinical Hospital ( Site 1206)
Saint Petersburg, Sankt-Peterburg, Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1208)
Saint Petersburg, Sankt-Peterburg, Russia
Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 120
Kazan', Tatarstan, Respublika, Russia
Seoul National University Bundang Hospital ( Site 2402)
Seongnam-si, Kyonggi-do, South Korea
Seoul National University Hospital ( Site 2401)
Seoul, , South Korea
Severance Hospital Yonsei University Health System ( Site 2400)
Seoul, , South Korea
Hospital Universitario Quiron Madrid ( Site 1352)
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitari Vall d Hebron ( Site 1350)
Barcelona, , Spain
Universitaetsspital Zuerich ( Site 1400)
Zuerich, Canton of Aargau, Switzerland
Hopitaux Universitaires de Geneve HUG. ( Site 1406)
Geneva, Canton of Geneva, Switzerland
Ospedale Regionale di Bellinzona e Valli ( Site 1407)
Bellinzona, Canton Ticino, Switzerland
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507)
Konya, Adana, Turkey (Türkiye)
Baskent University Adana Training Hospital ( Site 1508)
Adana, , Turkey (Türkiye)
Hacettepe Universitesi Tıp Fakultesi ( Site 1503)
Ankara, , Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi ( Site 1504)
Antalya, , Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi ( Site 1500)
Edirne, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1505)
Istanbul, , Turkey (Türkiye)
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1506)
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi ( Site 1502)
Izmir, , Turkey (Türkiye)
Churchill Hospital ( Site 1606)
Oxford, Worcestershire, United Kingdom
Christie NHS Foundation Trust ( Site 1601)
Manchester, , United Kingdom
Northern Centre for Cancer Care ( Site 1602)
Newcastle upon Tyne, , United Kingdom
Weston Park Hospital ( Site 1607)
Sheffield, , United Kingdom
Countries
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Related Links
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Merck Clinical Trial Information
Plain Language Summary
Other Identifiers
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MK-7339-002
Identifier Type: OTHER
Identifier Source: secondary_id
LYNK-002
Identifier Type: OTHER
Identifier Source: secondary_id
194694
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-003007-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7339-002
Identifier Type: -
Identifier Source: org_study_id