Breast Cancer Clinical Trial
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)
This study will evaluate the efficacy and safety of olaparib (MK-7339) monotherapy in participants with multiple types of advanced cancer (unresectable and/or metastatic) that: 1) have progressed or been intolerant to standard of care therapy; and 2) are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD).
For all participants:
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:
Is not a woman of childbearing potential (WOCBP).
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.
Has a known additional malignancy that is progressing or has required active treatment in the last 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded.
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.
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There are 126 Locations for this study
Tucson Arizona, 85721, United States
Fullerton California, 92835, United States
Los Angeles California, 90048, United States
San Francisco California, 94158, United States
Aurora Colorado, 80045, United States
Atlanta Georgia, 30322, United States
Augusta Georgia, 30912, United States
Lexington Kentucky, 40536, United States
Baltimore Maryland, 21201, United States More Info
Baltimore Maryland, 21237, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48202, United States
Lincoln Nebraska, 68510, United States More Info
Middletown New Jersey, 07748, United States More Info
Harrison New York, 10604, United States More Info
New York New York, 10010, United States
New York New York, 10016, United States
New York New York, 10065, United States More Info
Tulsa Oklahoma, 74133, United States
Philadelphia Pennsylvania, 19124, United States
Sioux Falls South Dakota, 57104, United States More Info
Saint George Utah, 84790, United States
Seattle Washington, 98101, United States
Seattle Washington, 98108, United States More Info
Berazategui Buenos Aires, B1884, Argentina More Info
Ciudad de Buenos Aires Caba, C1280, Argentina
Buenos Aires , C1012, Argentina More Info
Buenos Aires , C1118, Argentina More Info
+54 11 4827-7000
Darlinghurst New South Wales, 2010, Australia More Info
Port Macquarie New South Wales, 2444, Australia
Nedlands Western Australia, 6009, Australia
Toronto Ontario, M4N 3, Canada More Info
Montreal Quebec, H1T 2, Canada More Info
Montreal Quebec, H3T 1, Canada
Quebec , G1J 1, Canada
Medellin Antioquia, 05002, Colombia
Medellin Antioquia, 05003, Colombia
Barranquilla Atlantico, 08000, Colombia
Valledupar Cesar, 20000, Colombia More Info
Monteria Cordoba, 23000, Colombia
Bogota Distrito Capital De Bogota, 11022, Colombia More Info
5300470 Ext.: 2909
Bogota Distrito Capital De Bogota, 11031, Colombia
Bogota Distrito Capital De Bogota, 11151, Colombia
Cali Valle Del Cauca, 76004, Colombia
Copenhagen Hovedstaden, 2100, Denmark More Info
+45 35 45 35 45
Herlev Hovedstaden, 2730, Denmark More Info
+45 38 68 38 68
Odense Syddanmark, 5000, Denmark
Poitiers Ain, 86021, France More Info
Nice Alpes-Maritimes, 06189, France More Info
Strasbourg Alsace, 67033, France More Info
Dijon Bourgogne, 21000, France More Info
Bordeaux Gironde, 33076, France More Info
Villejuif Val-de-Marne, 94805, France More Info
Guatemala Quetzaltenango, 09001, Guatemala More Info
Guatemala , 01010, Guatemala More Info
Guatemala , 01010, Guatemala More Info
Guatemala , 01015, Guatemala More Info
Dublin Carlow, D07 W, Ireland
Cork , T12 D, Ireland More Info
Dublin , 00004, Ireland More Info
Dublin , D24 N, Ireland
Beer-Sheva , 84571, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel More Info
Ramat Gan , 52620, Israel More Info
Tel Aviv , 64239, Israel
Napoli Campania, 80131, Italy More Info
Rozzano Lombardia, 20089, Italy More Info
Siena Toscana, 53100, Italy More Info
Nagoya Aichi, 464-8, Japan
Kashiwa Chiba, 27785, Japan
Suita Osaka, 565-0, Japan
Kyoto , 606-8, Japan
Tokyo , 104-0, Japan
Tokyo , 135-8, Japan
Seongnam-si Kyonggi-do, 13620, Korea, Republic of More Info
Seoul , 03080, Korea, Republic of More Info
Seoul , 03722, Korea, Republic of
Guadalajara Jalisco, 44680, Mexico More Info
Monterrey Nuevo Leon, 64460, Mexico
Santiago De Quetaro Queretaro, 76000, Mexico More Info
Madero Tamaulipas, 89440, Mexico
Chihuahua , 31000, Mexico
Mexico City , 06100, Mexico More Info
Mexico , 03100, Mexico More Info
Oaxaca , 68000, Mexico More Info
Trujillo La Libertad, 13001, Peru More Info
Lima Muni Metro De Lima, 15038, Peru
Lima , 15033, Peru More Info
Lima , 15036, Peru More Info
Lima , 15036, Peru More Info
Lima , 15036, Peru More Info
Lima , 15046, Peru More Info
Lima , 15076, Peru More Info
Lima , 15082, Peru
Oradea Bihor, 41046, Romania
Cluj Napoca Cluj, 40064, Romania More Info
Comuna Floresti Cluj, 40728, Romania
Craiova Dolj, 20054, Romania More Info
Brasov , 50015, Romania More Info
Bucuresti , 02254, Romania More Info
Bucuresti , 03142, Romania
Arkhangelsk Arkhangel Skaya Oblast, 16304, Russian Federation
Chelyabinsk Chelyabinskaya Oblast, 45408, Russian Federation
Krasnogorsk Moskovskaya Oblast, 14344, Russian Federation
Moscow Moskva, 11547, Russian Federation
Moscow Moskva, 12528, Russian Federation
Ryazan Ryazanskaya Oblast, 39001, Russian Federation
Samara Samarskaya Oblast, 44303, Russian Federation
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Saint-Petersburg Sankt-Peterburg, 19404, Russian Federation
St.Petersburg Sankt-Peterburg, 19429, Russian Federation
Kazan Tatarstan, Respublika, 42002, Russian Federation
Pozuelo de Alarcon Madrid, 28223, Spain More Info
Barcelona , 08035, Spain More Info
Zuerich Aargau, 8091, Switzerland More Info
Geneva Geneve, 1211, Switzerland More Info
Bellinzona Ticino, 6500, Switzerland More Info
Konya Adana, 42080, Turkey More Info
Adana , 01250, Turkey More Info
Ankara , 06100, Turkey
Antalya , 07070, Turkey More Info
Edirne , 22030, Turkey More Info
Istanbul , 34098, Turkey More Info
Istanbul , 34722, Turkey More Info
Izmir , 35100, Turkey More Info
Oxford Worcestershire, OX3 7, United Kingdom More Info
Manchester , M20 4, United Kingdom
Newcastle upon Tyne , NE7 7, United Kingdom More Info
Sheffield , S10 2, United Kingdom More Info
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