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Cancer drug targets genetic weakness in advanced tumors

NCT ID NCT03742895

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This phase 2 study tests the drug olaparib in 329 people with advanced solid tumors that have certain DNA repair mutations (HRRm) or deficiencies (HRD). Participants have already tried standard treatments without success. The main goal is to see if olaparib can shrink tumors, with safety also monitored.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Olaparib (a PARP inhibitor taken as a pill)
What this could lead to
If successful, this could provide a new treatment option for people with certain advanced cancers that have specific genetic mutations or deficiencies.
What could go wrong
This is a mid-stage trial with no control group, so results are preliminary. Olaparib may not shrink tumors in all participants and can cause side effects like fatigue or nausea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

329 people

The number who actually took part.

Started

Dec 2018

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * For all participants: * Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by the local site Investigator/radiology and confirmed by Blinded independent central review (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 homologous recombination repair mutated (HRRm) but BRCA1/2 non-mutated, or homologous recombination repair non-mutated but homologous recombination deficiency (HRD) positive as centrally-confirmed by the Lynparza HRR-HRD Assay: * 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. * 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 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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Conditions

The condition(s) this trial relates to.

breast cancer cancer neoplasm sporadic breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid neoplasms

Contacts and locations

Locations

  • Actualidad Basada en la Investigacion del Cancer ( Site 2903)

    Guadalajara, Jalisco, 44680, Mexico

  • Administradora Country SA - Clinica del Country ( Site 2802)

    Bogotá, Bogota D.C., 110221, Colombia

  • Aichi Cancer Center Hospital ( Site 2602)

    Nagoya, Aichi-ken, 464-8681, Japan

  • Akdeniz Universitesi Tip Fakultesi ( Site 1504)

    Antalya, 07070, Turkey (Türkiye)

  • Arkhangelsk Clinical Oncological Dispensary ( Site 1204)

    Arkhangelsk, Arkhangelskaya oblast, 163045, Russia

  • Augusta University ( Site 0028)

    Augusta, Georgia, 30912, United States

  • Baskent University Adana Training Hospital ( Site 1508)

    Adana, 01250, Turkey (Türkiye)

  • Biomelab S A S ( Site 2800)

    Barranquilla, Atlántico, 080001, Colombia

  • Bon Secours Hospital ( Site 1656)

    Cork, T12 DV56, Ireland

  • C. Medico Imbanaco Cali S.A. ( Site 2810)

    Cali, Valle del Cauca Department, 760042, Colombia

  • CENEIT Oncologicos ( Site 2904)

    México, 03100, Mexico

  • CHU Poitiers ( Site 0612)

    Poitiers, Ain, 86021, France

  • CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 2900)

    Mexico City, 06100, Mexico

  • Cancer Partners of Nebraska ( Site 0051)

    Lincoln, Nebraska, 68510, United States

  • Cedars Sinai Medical Center ( Site 0002)

    Los Angeles, California, 90048, United States

  • Centre Antoine Lacassagne ( Site 0610)

    Nice, Alpes-Maritimes, 06189, France

  • Centre Georges Francois Leclerc ( Site 0608)

    Dijon, Bourgogne-Franche-Comté, 21000, France

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

    Québec, Quebec, G1J 1Z4, Canada

  • Centro Estatal de Cancerologia de Chihuahua ( Site 2907)

    Chihuahua City, 31000, Mexico

  • Centro Regional de Sub Especialidades Medicas SA ( Site 3003)

    Guatemala, Departamento de Quetzaltenango, 09001, Guatemala

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2901)

    Madero, Tamaulipas, 89440, Mexico

  • Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 3004)

    Guatemala City, 01010, Guatemala

  • Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703)

    Berazategui, Buenos Aires, B1884BBF, Argentina

  • Chaim Sheba Medical Center ( Site 0803)

    Ramat Gan, 5262000, Israel

  • Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1212)

    Chelyabinsk, Chelyabinsk Oblast, 454087, Russia

  • Christie NHS Foundation Trust ( Site 1601)

    Manchester, M20 4BX, United Kingdom

  • Churchill Hospital ( Site 1606)

    Oxford, Worcestershire, OX3 7LE, United Kingdom

  • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2807)

    Bogotá, Bogota D.C., 110311, Colombia

  • Clinica Internacional Sede San Borja ( Site 3100)

    Lima, 15036, Peru

  • Clinical Hospital Saint Luka ( Site 1205)

    Saint Petersburg, Sankt-Peterburg, 194044, Russia

  • Cuidados Oncologicos ( Site 2908)

    Santiago de Quetaro, Querétaro, 76000, Mexico

  • Eastern Regional Medical Center, Inc. ( Site 0077)

    Philadelphia, Pennsylvania, 19124, United States

  • Ege Universitesi Tip Fakultesi ( Site 1502)

    Izmir, 35100, Turkey (Türkiye)

  • Fundacion Centro de Investigacion Clinica CIC ( Site 2812)

    Medellín, Antioquia, 050021, Colombia

  • Grupo Angeles SA ( Site 3001)

    Guatemala City, 01015, Guatemala

  • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1506)

    Istanbul, 34722, Turkey (Türkiye)

  • Hacettepe Universitesi Tıp Fakultesi ( Site 1503)

    Ankara, 06100, Turkey (Türkiye)

  • Hadassah Ein Kerem Medical Center ( Site 0802)

    Jerusalem, 9112001, Israel

  • Henry Ford Health System ( Site 0060)

    Detroit, Michigan, 48202, United States

  • Herlev og Gentofte Hospital. ( Site 0401)

    Herlev, Capital Region, 2730, Denmark

  • Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203)

    Montreal, Quebec, H1T 2M4, Canada

  • Hopitaux Universitaires de Geneve HUG. ( Site 1406)

    Geneva, Canton of Geneva, 1211, Switzerland

  • Hospital Aleman ( Site 2702)

    Buenos Aires, C1118AAT, Argentina

  • Hospital Arzobispo Loayza ( Site 3103)

    Lima, 15082, Peru

  • Hospital Britanico de Buenos Aires ( Site 2704)

    Ciudad de Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina

  • Hospital Central de la Fuerza Aerea del Peru ( Site 3104)

    Lima, 15046, Peru

  • Hospital Militar Central Coronel Luis Arias Schereiber ( Site 3105)

    Lima, 15076, Peru

  • Hospital Nacional Guillermo Almenara Irigoyen ( Site 3107)

    Lima, 15033, Peru

  • Hospital Universitari Vall d Hebron ( Site 1350)

    Barcelona, 08035, Spain

  • Hospital Universitario Quiron Madrid ( Site 1352)

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 3102)

    Trujillo, La Libertad, 13006, Peru

  • Institut Bergonie ( Site 0603)

    Bordeaux, Gironde, 33076, France

  • Institut Gustave Roussy ( Site 0601)

    Villejuif, Val-de-Marne, 94805, France

  • Institut de Cancerologie Strasbourg Europe ( Site 0613)

    Strasbourg, Alsace, 67033, France

  • Instituto Nacional de Cancerologia E.S.E ( Site 2809)

    Bogotá, Bogota D.C., 111511, Colombia

  • Instituto Nacional de Enfermedades Neoplasicas ( Site 3106)

    Lima, Muni Metro de Lima, 15038, Peru

  • Instituto de Investigaciones Metabolicas ( Site 2700)

    Buenos Aires, C1012AAR, Argentina

  • Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 3101)

    Lima, 15036, Peru

  • Integra Cancer Institute ( Site 3006)

    Guatemala City, 01010, Guatemala

  • Intermountain Healthcare ( Site 0043)

    St. George, Utah, 84790, United States

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1505)

    Istanbul, 34098, Turkey (Türkiye)

  • Istituto Clinico Humanitas Research Hospital ( Site 0703)

    Rozzano, Lombardy, 20089, Italy

  • Istituto Nazionale Tumori Fondazione Pascale ( Site 0700)

    Naples, Campania, 80131, Italy

  • Jewish General Hospital ( Site 0209)

    Montreal, Quebec, H3T 1E2, Canada

  • Kinghorn Cancer Centre ( Site 2200)

    Darlinghurst, New South Wales, 2010, Australia

  • Kyoto University Hospital ( Site 2603)

    Kyoto, Kyoto, 606-8507, Japan

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057)

    New York, New York, 10016, United States

  • Linear Clinical Research Ltd ( Site 2202)

    Nedlands, Western Australia, 6009, Australia

  • MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1216)

    Krasnogorsk, Moscow Oblast, 143442, Russia

  • MNCCI Port Macquarie Base Hospital ( Site 2201)

    Port Macquarie, New South Wales, 2444, Australia

  • MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1213)

    Moscow, Moscow, 125284, Russia

  • Markey Cancer Center ( Site 0018)

    Lexington, Kentucky, 40536, United States

  • Mater Misericordiae University Hospital ( Site 1654)

    Dublin, Carlow, D07 WKW8, Ireland

  • Medisprof ( Site 1107)

    Cluj-Napoca, Cluj, 400641, Romania

  • Memorial Sloan Kettering Cancer Center ( Site 0026)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126)

    Harrison, New York, 10604, United States

  • N.N. Blokhin NMRCO ( Site 1201)

    Moscow, Moscow, 115477, Russia

  • National Cancer Center Hospital ( Site 2601)

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East ( Site 2600)

    Kashiwa, Chiba, 2778577, Japan

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507)

    Konya, Adana, 42080, Turkey (Türkiye)

  • Northern Centre for Cancer Care ( Site 1602)

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Oaxaca Site Management Organization S.C. ( Site 2905)

    Oaxaca City, 68000, Mexico

  • Odense Universitetshospital ( Site 0400)

    Odense, Region Syddanmark, 5000, Denmark

  • Oncomedica S.A. ( Site 2806)

    Montería, Departamento de Córdoba, 230002, Colombia

  • Oncosalud-Clinical Research ( Site 3108)

    Lima, 15036, Peru

  • Osaka University Hospital ( Site 2604)

    Suita, Osaka, 565-0871, Japan

  • Ospedale Regionale di Bellinzona e Valli ( Site 1407)

    Bellinzona, Canton Ticino, 6500, Switzerland

  • Policlinico Le Scotte di Siena ( Site 0704)

    Siena, Tuscany, 53100, Italy

  • Rambam Health Care Campus-Oncology Division ( Site 0801)

    Haifa, 3109601, Israel

  • Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 120

    Kazan', Tatarstan, Respublika, 420029, Russia

  • Rigshospitalet ( Site 0402)

    Copenhagen, Capital Region, 2100, Denmark

  • Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092)

    Aurora, Colorado, 80045, United States

  • Rodrigo Botero SAS ( Site 2801)

    Medellín, Antioquia, 050030, Colombia

  • Ryazan Regional Clinical Oncology dispensary ( Site 1202)

    Ryazan, Ryazan Oblast, 390011, Russia

  • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)

    Craiova, Dolj, 200542, Romania

  • S.C. Pelican Impex S.R.L Spitalul Clinic Pelican Oradea ( Site 1102)

    Oradea, Bihor County, 410469, Romania

  • S.C.Focus Lab Plus S.R.L ( Site 1101)

    Bucharest, 022548, Romania

  • S.C.Gral Medical S.R.L ( Site 1104)

    Bucharest, 031422, Romania

  • SBHI Leningrad Regional Clinical Hospital ( Site 1206)

    Saint Petersburg, Sankt-Peterburg, 194291, Russia

  • SBHI Samara Regional Clinical Oncology Dispensary ( Site 1211)

    Samara, Samara Oblast, 443031, Russia

  • SC Radiotherapy Center Cluj SRL ( Site 1105)

    Comuna Floresti, Cluj, 407280, Romania

  • Sanford Hematology Oncology-Sioux Falls SD ( Site 0012)

    Sioux Falls, South Dakota, 57104, United States

  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1208)

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Seoul National University Bundang Hospital ( Site 2402)

    Seongnam-si, Kyonggi-do, 13620, South Korea

  • Seoul National University Hospital ( Site 2401)

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System ( Site 2400)

    Seoul, 03722, South Korea

  • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2808)

    Valledupar, Cesar Department, 200001, Colombia

  • Soroka Medical Center ( Site 0800)

    Beersheba, 8457108, Israel

  • Sourasky Medical Center ( Site 0804)

    Tel Aviv, 6423906, Israel

  • Southwestern Regional Medical Center, Inc. ( Site 0079)

    Tulsa, Oklahoma, 74133, United States

  • Spitalul PDR Medlife ( Site 1106)

    Brasov, 500152, Romania

  • St Joseph Heritage Healthcare-Oncology ( Site 0056)

    Fullerton, California, 92835, United States

  • St. Vincent's University Hospital ( Site 1653)

    Dublin, 00004, Ireland

  • Sunnybrook Research Institute ( Site 0210)

    Toronto, Ontario, M4N 3M5, Canada

  • Tallaght University Hospital ( Site 1652)

    Dublin, D24 NROA, Ireland

  • The Cancer Institute Hospital of JFCR ( Site 2605)

    Tokyo, 135-8550, Japan

  • The University of Arizona Cancer Center - North Campus ( Site 0011)

    Tucson, Arizona, 85719, United States

  • Trakya Universitesi Tip Fakultesi ( Site 1500)

    Edirne, 22030, Turkey (Türkiye)

  • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)

    San Francisco, California, 94158, United States

  • Unidad Biomedica Avanzada Monterrey S. A. ( Site 2902)

    Monterrey, Nuevo León, 64460, Mexico

  • Universitaetsspital Zuerich ( Site 1400)

    Zuerich, Canton of Aargau, 8091, Switzerland

  • University of Maryland ( Site 0050)

    Baltimore, Maryland, 21201, United States

  • University of Massachusetts ( Site 0017)

    Worcester, Massachusetts, 01655, United States

  • VA New York Harbor Healthcare System Manhattan ( Site 0094)

    New York, New York, 10010, United States

  • Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093)

    Seattle, Washington, 98108, United States

  • Virginia Mason Medical Center ( Site 0052)

    Seattle, Washington, 98101, United States

  • Weinberg Cancer Institute at Franklin Square ( Site 0054)

    Baltimore, Maryland, 21237, United States

  • Weston Park Hospital ( Site 1607)

    Sheffield, S10 2SJ, United Kingdom

  • Winship Cancer Institute of Emory University ( Site 0025)

    Atlanta, Georgia, 30322-1013, United States

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