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Trial record 28 of 195 for:    Oral Cancer | ( Map: Mexico )

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742895
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : December 5, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Advanced Solid Neoplasms Drug: Olaparib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Olaparib

Arm Intervention/treatment
Experimental: Olaparib
Participants with HRRm or HRD-positive advanced cancer will receive oral olaparib, 300 mg twice daily (BID).
Drug: Olaparib
Olaparib 300 mg administered BID as two, 150 mg oral tablets.
Other Names:
  • MK-7339
  • AZD2281
  • KU-0059436
  • LYNPARZA®




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 53 months ]
    ORR is defined as the percentage of participants who achieve a confirmed complete response ([CR]; disappearance of all target lesions) or partial response ([PR]: ≥30% decrease in the sum of diameters of target lesions) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). For participants with prostate cancer, ORR will be based on Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by BICR.


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Up to 53 months ]
    DOR is defined as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death due to any cause, whichever occurs first. DOR will be assessed by BICR according to either RECIST 1.1 or PCWG-modified RECIST 1.1 for participants with prostate cancer.

  2. Overall Survival (OS) [ Time Frame: Up to 53 months ]
    OS is defined as the time from the date of the first dose to the date of death due to any cause.

  3. Progression Free Survival (PFS) [ Time Frame: Up to 53 months ]
    PFS is defined as the time from the date of the first dose to either: 1) the first documented disease progression as assessed either by BICR according to RECIST 1.1 or PCWG-modified RECIST 1.1 for participants with prostate cancer; or 2) death due to any cause, whichever occurs first.

  4. Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to 53 months ]
    An AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing an AE will be assessed.

  5. Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE) [ Time Frame: Up to 52 months ]
    The number of participants discontinuing study treatment due to an AE will be assessed.

  6. Time to Earliest Progression by Cancer Antigen-125 (CA-125) [ Time Frame: Up to 53 months ]
    For participants with BRCA1/2 non-mutated ovarian cancer only, the time to earliest progression by CA-125 will be assessed. Progression by CA-125 is defined as an increase in CA-125 level ≥2x upper limit normal (ULN) on 2 occasions, 1 week apart. For participants with elevated CA-125 (≥ULN) at baseline, progression by CA-125 is defined as an increase in CA-125 level ≥2x the nadir value on 2 occasions, 1 week apart.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor (except breast or ovarian cancers whose tumor has a germline or somatic 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.
  • 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 3 days of treatment initiation.
  • Male participants must agree to use contraception during the treatment period and for at least 90 days (3 months) after the last dose of study treatment and refrain from donating sperm during this period.
  • Female participants must not be pregnant or breastfeeding. Additionally, female participants must either not be a woman of childbearing potential (WOCBP) or, if a WOCBP, agree to use contraception during the treatment period and for at least 30 days (1 month) after the last dose of study treatment.
  • Has adequate organ function.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742895


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

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Locations
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United States, Arizona
The University of Arizona Cancer Center - North Campus ( Site 0011) Recruiting
Tucson, Arizona, United States, 85721
Contact: Study Coordinator    520-694-9049      
United States, California
St. Joseph Heritage Healthcare ( Site 0056) Recruiting
Fullerton, California, United States, 92835
Contact: Study Coordinator    7149923000x4332      
Cedars Sinai Medical Center ( Site 0002) Recruiting
Los Angeles, California, United States, 90048
Contact: Study Coordinator    310-248-7443      
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007) Recruiting
San Francisco, California, United States, 94158
Contact: Study Coordinator    415-885-7604      
United States, Georgia
Winship Cancer Institute of Emory University ( Site 0025) Recruiting
Atlanta, Georgia, United States, 30322-1013
Contact: Study Coordinator    404-778-4383      
Augusta University ( Site 0028) Recruiting
Augusta, Georgia, United States, 30912
Contact: Study Coordinator    706-721-4430      
United States, Kentucky
Markey Cancer Center ( Site 0018) Recruiting
Lexington, Kentucky, United States, 40536
Contact: Study Coordinator    859-257-9568      
United States, Maryland
University of Maryland ( Site 0050) Recruiting
Baltimore, Maryland, United States, 21201
Contact: Study Coordinator    410-328-7224      
United States, Massachusetts
University of Massachusetts ( Site 0017) Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Study Coordinator    508-856-3216      
United States, Michigan
Henry Ford Health System ( Site 0060) Recruiting
Detroit, Michigan, United States, 48202
Contact: Study Coordinator    313-916-9826      
United States, Nebraska
Southeast Nebraska Cancer Center ( Site 0051) Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Study Coordinator    402-327-7363      
United States, New Jersey
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Study Coordinator    646-888-5089      
United States, New York
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126) Recruiting
Harrison, New York, United States, 10604
Contact: Study Coordinator    646-888-5089      
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057) Recruiting
New York, New York, United States, 10016
Contact: Study Coordinator    212-731-7921      
Memorial Sloan Kettering Cancer Center ( Site 0026) Recruiting
New York, New York, United States, 10065
Contact: Study Coordinator    646-888-5089      
United States, Oklahoma
Southwestern Regional Medical Center, Inc. ( Site 0079) Recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Study Coordinator    918-286-5206      
United States, Pennsylvania
Eastern Regional Medical Center, Inc. ( Site 0077) Recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact: Study Coordinator    215-537-6438      
United States, South Dakota
Sanford Hematology Oncology-Sioux Falls SD ( Site 0012) Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Study Coordinator    701-234-2858      
United States, Utah
Intermountain Healthcare ( Site 0043) Recruiting
Saint George, Utah, United States, 84790
Contact: Study Coordinator    435-251-4743      
United States, Washington
Virginia Mason Medical Center ( Site 0052) Recruiting
Seattle, Washington, United States, 98101
Contact: Study Coordinator    206-287-6272      
Argentina
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703) Recruiting
Berazategui, Buenos Aires, Argentina, B1884BBF
Contact: Study Coordinator    541142262013      
Hospital Britanico de Buenos Aires ( Site 2704) Recruiting
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1280AEB
Contact: Study Coordinator    +541143096897      
Instituto de Investigaciones Metabolicas ( Site 2700) Recruiting
Buenos Aires, Argentina, C1012AAR
Contact: Study Coordinator    +541146356624      
Hospital Aleman ( Site 2702) Recruiting
Buenos Aires, Argentina, C1118AAT
Contact: Study Coordinator    +5411482770002955      
Australia, New South Wales
MNCCI Port Macquarie Base Hospital ( Site 2201) Recruiting
Port Macquarie, New South Wales, Australia, 2444
Contact: Study Coordinator    +61265801818      
Australia, Sydney
Kinghorn Cancer Centre ( Site 2200) Recruiting
Darlinghurst, Sydney, Australia, 2010
Contact: Study Coordinator    +61293555655      
Australia, Western Australia
Linear Clinical Research Ltd ( Site 2202) Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Study Coordinator    +61864573333      
Canada, Quebec
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203) Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Study Coordinator    51425234005853      
Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0204) Recruiting
Quebec, Canada, G1R 2J6
Contact: Study Coordinator    4185254444x20414      
Colombia
Fundacion Centro de Investigacion Clinica CIC ( Site 2812) Recruiting
Medellin, Antioquia, Colombia, 050021
Contact: Study Coordinator    +573122885210      
Rodrigo Botero SAS ( Site 2801) Recruiting
Medellin, Antioquia, Colombia, 050030
Contact: Study Coordinator    +5743490799      
Instituto Nacional de Cancerologia E.S.E ( Site 2809) Recruiting
Bogota, Cundinamarca, Colombia, 111511
Contact: Study Coordinator    +5714320160Ext4217      
Biomelab S A S ( Site 2800) Recruiting
Barranquilla, Colombia, 080002
Contact: Study Coordinator    +5753692451      
Administradora Country SA - Clinica del Country ( Site 2802) Recruiting
Bogota, Colombia, 110221
Contact: Study Coordinator    +5715300470      
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2807) Recruiting
Bogota, Colombia, 110311
Contact: Study Coordinator    +573016410749      
C. Medico Imbanaco Cali S.A. ( Site 2810) Recruiting
Cali, Colombia, 760042
Contact: Study Coordinator    +5726821000      
Oncomedica S.A. ( Site 2806) Recruiting
Monteria, Colombia, 230002
Contact: Study Coordinator    +573157962122      
Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 2808) Recruiting
Valledupar, Colombia, 200002
Contact: Study Coordinator    +5755602310      
Denmark
Rigshospitalet ( Site 0402) Recruiting
Copenhagen, Denmark, 2100
Contact: Study Coordinator    +4535457966      
Herlev og Gentofte Hospital. ( Site 0401) Recruiting
Herlev, Denmark, 2730
Contact: Study Coordinator    +4538689381      
Odense Universitetshospital ( Site 0400) Recruiting
Odense, Denmark, 5000
Contact: Study Coordinator    +4565413238      
France
Institut Bergonie ( Site 0603) Recruiting
Bordeaux, France, 33076
Contact: Study Coordinator    +33556333333      
Centre Georges Francois Leclerc ( Site 0608) Recruiting
Dijon, France, 21000
Contact: Study Coordinator    +33380737506      
Centre Antoine Lacassagne ( Site 0610) Recruiting
Nice, France, 06189
Contact: Study Coordinator    +33492031514      
CHU Poitiers ( Site 0612) Recruiting
Poitiers, France, 86021
Contact: Study Coordinator    +33549441496      
Centre Paul Strauss ( Site 0613) Recruiting
Strasbourg, France, 67065
Contact: Study Coordinator    +33388252485      
Institut Gustave Roussy ( Site 0601) Recruiting
Villejuif, France, 94805
Contact: Study Coordinator    +33142114296      
Guatemala
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 3004) Recruiting
Guatemala, Guatemala, 01010
Contact: Study Coordinator    +50259458053      
Integra Cancer Institute ( Site 3006) Recruiting
Guatemala, Guatemala, 01010
Contact: Study Coordinator    +50254530410      
Grupo Angeles SA ( Site 3001) Recruiting
Guatemala, Guatemala, 01015
Contact: Study Coordinator    +50240492110      
Centro Regional de Sub Especialidades Medicas SA ( Site 3003) Recruiting
Quetzaltenango, Guatemala, 09001
Contact: Study Coordinator    +50259450559      
Ireland
Bon Secours Hospital ( Site 1656) Recruiting
Cork, Ireland, T12 DV56
Contact: Study Coordinator    +353214345495      
St. Vincent's University Hospital ( Site 1653) Recruiting
Dublin, Ireland, D04 T6F4
Contact: Study Coordinator    +35314144259      
Mater Misericordiae University Hospital ( Site 1654) Recruiting
Dublin, Ireland, D07 WKW8
Contact: Study Coordinator    +353018034838      
Tallaght University Hospital ( Site 1652) Recruiting
Dublin, Ireland, D24 NROA
Contact: Study Coordinator    +35314144259      
Israel
Rambam Medical Center ( Site 0801) Recruiting
Haifa, Israel, 3109601
Contact: Study Coordinator    +97247773003      
Hadassah Ein Kerem Medical Center ( Site 0802) Recruiting
Jerusalem, Israel, 9112001
Contact: Study Coordinator    +97226777825      
Chaim Sheba Medical Center ( Site 0803) Recruiting
Ramat Gan, Israel, 5262000
Contact: Study Coordinator    +97235302243      
Sourasky Medical Center ( Site 0804) Recruiting
Tel Aviv, Israel, 6423906
Contact: Study Coordinator    +97236973082      
Italy
Istituto Nazionale Tumori Fondazione Pascale ( Site 0700) Recruiting
Napoli, Italy, 80131
Contact: Study Coordinator    +390815903431      
Humanitas Research Hospital ( Site 0703) Recruiting
Rozzano, Italy, 20089
Contact: Study Coordinator    +390282244080      
Policlinico Le Scotte di Siena ( Site 0704) Recruiting
Siena, Italy, 53100
Contact: Study Coordinator    +390577586335      
Japan
Aichi Cancer Center Hospital ( Site 2602) Recruiting
Nagoya, Aichi, Japan, 464-8681
Contact: Study Coordinator    +81527626111      
National Cancer Center Hospital East ( Site 2600) Recruiting
Kashiwa, Chiba, Japan, 277-8577
Contact: Study Coordinator    +81471331111      
Osaka University Hospital ( Site 2604) Recruiting
Suita, Osaka, Japan, 565-0871
Contact: Study Coordinator    +81668795111      
Kyoto University Hospital ( Site 2603) Recruiting
Kyoto, Japan, 606-8507
Contact: Study Coordinator    +81757513111      
National Cancer Center Hospital ( Site 2601) Recruiting
Tokyo, Japan, 104-0045
Contact: Study Coordinator    +81335422511      
The Cancer Institute Hospital of JFCR ( Site 2605) Recruiting
Tokyo, Japan, 135-8550
Contact: Study Coordinator    +81335200111      
Korea, Republic of
Seoul National University Bundang Hospital ( Site 2402) Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Study Coordinator    +82317877022      
Seoul National University Hospital ( Site 2401) Recruiting
Seoul, Korea, Republic of, 03080
Contact: Study Coordinator    +82220720850      
Severance Hospital Yonsei University Health System ( Site 2400) Recruiting
Seoul, Korea, Republic of, 03722
Contact: Study Coordinator    +82222288132      
Mexico
Actualidad Basada en la Investigacion del Cancer ( Site 2903) Recruiting
Guadalajara, Jalisco, Mexico, 44680
Contact: Study Coordinator    +523313141707      
Unidad Biomedica Avanzada Monterrey S. A. ( Site 2902) Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Study Coordinator    +528113578894      
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2901) Recruiting
Madero, Tamaulipas, Mexico, 89440
Contact: Study Coordinator    +528332142554      
Centro Estatal de Cancerologia de Chihuahua ( Site 2907) Recruiting
Chihuahua, Mexico, 31000
Contact: Study Coordinator    +526144106742      
Consultorio de Medicina Especializada del Sector Privado ( Site 2904) Recruiting
Mexico City, Mexico, 03100
Contact: Study Coordinator    +5215529009882      
CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 2900) Recruiting
Mexico City, Mexico, 06100
Contact: Study Coordinator    +525555743589      
Oaxaca Site Management Organization S.C. ( Site 2905) Recruiting
Oaxaca, Mexico, 68000
Contact: Study Coordinator    +5209515147056      
Cuidados Oncologicos ( Site 2908) Recruiting
Santiago De Quetaro, Mexico, 76000
Contact: Study Coordinator    +524422428555      
Peru
Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 3102) Recruiting
Trujillo, La Libertad, Peru, 13006
Contact: Study Coordinator    +51964820298      
Hospital Nacional Guillermo Almenara Irigoyen ( Site 3107) Recruiting
Lima, Peru, 15033
Contact: Study Coordinator    +51999903343      
Clinica Internacional Sede San Borja ( Site 3100) Recruiting
Lima, Peru, 15036
Contact: Study Coordinator    +51999611475      
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 3101) Recruiting
Lima, Peru, 15036
Contact: Study Coordinator    +51995220364      
Instituto Nacional de Enfermedades Neoplasicas ( Site 3106) Recruiting
Lima, Peru, 15038
Contact: Study Coordinator    +51999389433      
Hospital Central de la Fuerza Aerea del Peru ( Site 3104) Recruiting
Lima, Peru, 15046
Contact: Study Coordinator    +51997346037      
Hospital Militar Central Coronel Luis Arias Schereiber ( Site 3105) Recruiting
Lima, Peru, 15076
Contact: Study Coordinator    +51997468543      
Hospital Arzobispo Loayza ( Site 3103) Recruiting
Lima, Peru, 15082
Contact: Study Coordinator    +51987421693      
Romania
S.C. Pelican Impex S.R.L Spitalul Clinic Pelican Oradea ( Site 1102) Recruiting
Oradea, Bihor, Romania, 410469
Contact: Study Coordinator    +40746103306      
SC Radiotherapy Center Cluj SRL ( Site 1105) Recruiting
Comuna Floresti, Cluj, Romania, 407280
Contact: Study Coordinator    +40742206212      
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103) Recruiting
Craiova, Dolj, Romania, 200347
Contact: Study Coordinator    +40727774974      
Spitalul PDR Medlife ( Site 1106) Recruiting
Brasov, Romania, 500152
Contact: Study Coordinator    +40722559551      
S.C.Focus Lab Plus S.R.L ( Site 1101) Recruiting
Bucuresti, Romania, 021389
Contact: Study Coordinator    +40721298677      
S.C.Gral Medical S.R.L ( Site 1104) Recruiting
Bucuresti, Romania, 031422
Contact: Study Coordinator    +40723954705      
Medisprof ( Site 1107) Recruiting
Cluj Napoca, Romania, 400641
Contact: Study Coordinator    +40751274636      
Russian Federation
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1212) Recruiting
Chelyabinsk, Chelyabinsk Region, Russian Federation, 454087
Contact: Study Coordinator    +79127949047      
Arkhangelsk Clinical Oncological Dispensary ( Site 1204) Recruiting
Arkhangelsk, Russian Federation, 163045
Contact: Study Coordinator    +79212469153      
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1207) Recruiting
Kazan, Russian Federation, 420029
Contact: Study Coordinator    +79179315577      
N.N. Blokhin NMRCO ( Site 1201) Recruiting
Moscow, Russian Federation, 115477
Contact: Study Coordinator    +79031990755      
MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1213) Recruiting
Moscow, Russian Federation, 125284
Contact: Study Coordinator    +79262110975      
Ryazan Regional Clinical Oncology dispensary ( Site 1202) Recruiting
Ryazan, Russian Federation, 390011
Contact: Study Coordinator    +79106436814      
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1208) Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Study Coordinator    +79219437168      
Clinical Hospital Saint Luka ( Site 1205) Recruiting
Saint-Petersburg, Russian Federation, 194044
Contact: Study Coordinator    +79817217460      
SBHI Samara Regional Clinical Oncology Dispensary ( Site 1211) Recruiting
Samara, Russian Federation, 443031
Contact: Study Coordinator    +79276551000      
SBHI Leningrad Regional Clinical Hospital ( Site 1206) Recruiting
St.Petersburg, Russian Federation, 194291
Contact: Study Coordinator    +78125922529      
Spain
Hospital Universitario Quiron Madrid ( Site 1352) Recruiting
Pozuelo de Alarcon, Madrid, Spain, 28223
Contact: Study Coordinator    +34914521987      
Hospital Universitari Vall d Hebron ( Site 1350) Recruiting
Barcelona, Spain, 08035
Contact: Study Coordinator    +34934894158      
Switzerland
Ospedale Regionale di Bellinzona e Valli ( Site 1407) Recruiting
Bellinzona, Switzerland, 6500
Contact: Study Coordinator    +41918118194      
Hopitaux Universitaires de Geneve HUG. ( Site 1406) Recruiting
Geneva, Switzerland, 1211
Contact: Study Coordinator    +41795532353      
Universitaetsspital Zuerich ( Site 1400) Recruiting
Zuerich, Switzerland, 8091
Contact: Study Coordinator    +41442552214      
Turkey
Medeniyet Universitesi Tip Fakultesi ( Site 1506) Recruiting
Istanbul, Kadikoy, Turkey, 34732
Contact: Study Coordinator    +905063509061      
Baskent University Adana Training Hospital ( Site 1508) Recruiting
Adana, Turkey, 01250
Contact: Study Coordinator    +905353067506      
Hacettepe Universitesi Tıp Fakultesi ( Site 1503) Recruiting
Ankara, Turkey, 06100
Contact: Study Coordinator    +9031230543304336      
Akdeniz Universitesi Tip Fakultesi ( Site 1504) Recruiting
Antalya, Turkey, 07070
Contact: Study Coordinator    +905052312377      
Trakya Universitesi Tip Fakultesi ( Site 1500) Recruiting
Edirne, Turkey, 22030
Contact: Study Coordinator    +905322480988      
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1505) Recruiting
Istanbul, Turkey, 34098
Contact: Study Coordinator    +905052312377      
Ege Universitesi Tıp Fakultesi ( Site 1502) Recruiting
Izmir, Turkey, 34722
Contact: Study Coordinator    +902323903911      
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507) Recruiting
Konya, Turkey, 42080
Contact: Study Coordinator    +905322679838      
United Kingdom
Christie NHS Foundation Trust ( Site 1601) Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Study Coordinator    +441642282516      
Northern Centre for Cancer Care ( Site 1602) Recruiting
Newcastle-upon-Tyne, United Kingdom, NE7 7DN
Contact: Study Coordinator    +441912138476      
Churchill Hospital ( Site 1606) Recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Study Coordinator    +441865227212      
Weston Park Hospital ( Site 1607) Recruiting
Sheffield, United Kingdom, S10 2SJ
Contact: Study Coordinator    +44114226522      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
AstraZeneca
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03742895     History of Changes
Other Study ID Numbers: 7339-002
MK-7339-002 ( Other Identifier: Merck Protocol Number )
2018-003007-19 ( EudraCT Number )
LYNK-002 ( Other Identifier: Merck )
194694 ( Registry Identifier: JAPIC-CTI )
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents