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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7339-002 | Other Identifier | MSD | |
| LYNK-002 | Other Identifier | MSD | |
| 194694 | Registry Identifier | JAPIC-CTI | |
| 2022-500797-34-00 | Registry Identifier | EU CT | |
| U1111-1278-1505 | Registry Identifier | UTN | |
| 2018-003007-19 | EudraCT Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: BRCA1/2 | Experimental | Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had Loss of Heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib,300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met. |
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| Cohort 2: HRD+, HRR Non-mutated | Experimental | Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a LOH score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+(BRCA1/2 non-mutated/HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met. |
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| Cohort 2: HRRm, BRCA Non-mutated | Experimental | Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated [HRRm] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib | Drug | Olaparib 300 mg administered BID as two, 150 mg oral tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| All Cohorts: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 | ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: no evidence of disease [NED] on bone scan; PR: non-progressive disease, non-evaluable [NE], NED, or CR on bone scan). Per protocol, RECIST 1.1 was modified to allow ≤ 10 target lesions in total (up to 5 per organ). The percentage of participants who experienced a CR or PR as assessed by BICR is presented. | Up to approximately 78 months |
| Measure | Description | Time Frame |
|---|---|---|
| All Cohorts: Duration of Response (DOR) as Assessed by BICR According to Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 | DOR was defined as the time from first documented CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) to progressive disease (PD) or death among participants with confirmed CR or PR as assessed by BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: NED on bone scan; PR: non progressive disease, NE, NED, or CR on bone scan). Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions in total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm or the appearance of ≥1 new lesions; PD confirmation (>4 weeks after initial PD) was required for participants remaining on treatment. Per PCWG, PD was >2 new bone lesions (not tumor flare) persisting >6 weeks. DOR as assessed by BICR is presented. |
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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:
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 non-mutated:
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 BRCA1 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:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona Cancer Center - North Campus ( Site 0011) | Tucson | Arizona | 85719 | United States | ||
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| Label | URL |
|---|---|
| Merck Clinical Trial Information | View source |
| Plain Language Summary | View source |
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|
| Cohort 3: sBRCAm Breast Cancer | Experimental | Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met. |
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| Up to approximately 78 months |
| All Cohorts: Overall Survival (OS) | OS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. OS will be reported for all participants. | Up to approximately 78 months |
| All Cohorts: Progression Free Survival (PFS) as Assessed by BICR per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 | PFS was defined as the time from first dose of study treatment to the first documented PD or death due to any cause whichever occurred first among participants as assessed by BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria. Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions in total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm or the appearance of ≥1 new lesion; PD confirmation (>4 weeks after initial PD) was required for participants remaining on treatment. Per PCWG, PD was >2 new bone lesions (not tumor flare) persisting >6 weeks. PFS as assessed by BICR is presented. | Up to approximately 78 months |
| All Cohorts: Number of Participants Experiencing an Adverse Event (AE) | An AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. | Up to approximately 78 months |
| All Cohorts: Number of Participants Discontinuing Study Treatment due to an AE | An AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported. | Up to approximately 78 months |
| Combined Cohort 1+2: ORR as Assessed by BICR per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in Participants who are HRRm Positive | ORR was defined as the percentage of participants who have a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: NED on bone scan; PR: non-progressive disease, NE, NED, or CR on bone scan). Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions in total (up to 5 per organ). Per protocol, Cohort 1 and Cohort 2 were combined as a pre-specified secondary efficacy analysis population. Per protocol, the secondary ORR outcome measure analysis for HRRm positive participants in Cohort 1 (BRCA 1/2) and Cohort 2 [(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)] combined is presented. | Up to approximately 78 months |
| Progression-Free Survival After Next-Line Treatment in Participants with somatic BRCA1/2 mutations (sBRCAm) Breast Cancer | For participants with sBRCAm breast cancer, the PFS after next-line treatment will be presented. PFS is defined as the time from the date of the first dose to either: 1) the first documented disease progression on the next-line of treatment, as assessed by BICR according to modified RECIST 1.1; or 2) death due to any cause, whichever occurs first. | Up to approximately 78 months |
| Combined Cohort 1+2: ORR as Assessed by BICR per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 In Participants who are HRD Positive (HRD+) | ORR was defined as the percentage of participants who have a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: NED on bone scan; PR: non-progressive disease, NE, NED, or CR on bone scan). Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions in total (up to 5 per organ). Per protocol, Cohort 1 and Cohort 2 were combined as a pre-specified secondary efficacy analysis population. Per protocol, the secondary ORR outcome measure analysis for HRD+ participants in Cohort 1 (BRCA 1/2) and Cohort 2 [(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)] combined is presented. | Up to approximately 78 months |
| Combined Cohort 1+2: ORR as Assessed by BICR per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in All Combined Cohort 1+2 Participants Regardless of Biomarker Status | ORR was defined as the percentage of participants who have a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: NED on bone scan; PR: non-progressive disease, NE, NED, or CR on bone scan). Per protocol, RECIST 1.1 was modified to allow ≤ 10 target lesions in total (up to 5 per organ). Per protocol, the secondary ORR outcome measure analysis for all participants regardless of biomarker status in Cohort 1 (BRCA 1/2) and Cohort 2 ([HRRm, BRCA Non-mutated]; [HRD+, HRR Non-mutated]) combined is presented. | Up to approximately 78 months |
| Combined Cohort 1+2: DOR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in Participants who are HRRm Positive | DOR was defined as the time from first documented CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) to PD or death among participants with confirmed CR or PR as assessed by BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: NED on bone scan; PR: non-progressive disease, NE, NED, or CR on bone scan). Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions in total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions with an absolute increase of ≥5 mm or the appearance of ≥1 new lesions; PD confirmation (>4 weeks after initial PD) was required for participants remaining on treatment. Per PCWG, PD was >2 new bone lesions (not tumor flare) persisting >6 weeks. Cohort 1 & 2 were combined as secondary efficacy population and DOR for HRRm-positive participants is presented. | Up to approximately 78 months |
| Combined Cohort 1+2: DOR as Assessed by BICR per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 In Participants Who Are HRD Positive (HRD+) | DOR was defined as the time from first documented CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) to PD or death among participants with confirmed CR or PR as assessed by BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: NED on bone scan; PR: non-progressive disease, NE, NED, or CR on bone scan). Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions in total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions with an absolute increase of ≥5 mm or the appearance of ≥1 new lesions; PD confirmation (>4 weeks after initial PD) was required for participants remaining on treatment. Per PCWG, PD was >2 new bone lesions (not tumor flare) persisting >6 weeks. Cohort 1 & 2 were combined as secondary efficacy population and DOR for HRD+ participants is presented. | Up to approximately 78 months |
| Combined Cohort 1+2: DOR as Assessed by BICR per modified RECIST 1.1 or PCWG-modified RECIST 1.1 in All Combined Cohort 1+2 Participants Regardless of Biomarker Status | DOR was defined as the time from first documented CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) to PD or death among participants with confirmed CR or PR as assessed by BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: NED on bone scan; PR: non progressive disease, NE, NED, or CR on bone scan). Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions in total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions with an absolute increase of ≥5 mm or the appearance of ≥1 new lesions; PD confirmation (>4 weeks after initial PD) was required for participants remaining on treatment. Per PCWG, PD was >2 new bone lesions (not tumor flare) persisting >6 weeks. DOR for all participants regardless of biomarker status is presented. | Up to approximately 78 months |
| Combined Cohort 1+2: OS in Participants who are HRRm Positive | OS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. OS will be reported for all participants. | Up to approximately 78 months |
| Combined Cohort 1+2: OS in Participants who are HRD Positive (HRD+) | OS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. OS will be reported for all participants. | Up to approximately 78 months |
| Combined Cohort 1+2: OS in All Combined Cohort 1+2 Participants Regardless of Biomarker Status | OS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. OS will be reported for all participants. | Up to approximately 78 months |
| Combined Cohort 1+2: PFS as Assessed by BICR per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in Participants who are HRRm Positive | PFS was defined as the time from first dose of study treatment to the first documented PD or death due to any cause whichever occurred first among participants as assessed by BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG modified RECIST 1.1 criteria. Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions in total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm or the appearance of ≥1 new lesion; PD confirmation (>4 weeks after initial PD) was required for participants remaining on treatment. Per PCWG, PD was >2 new bone lesions (not tumor flare) persisting >6 weeks. Per protocol, the secondary PFS outcome measure analysis for HRRm positive participants in Cohort 1 (BRCA 1/2) and Cohort 2 [(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)] combined is presented. | Up to approximately 78 months |
| Combined Cohort 1+2: PFS as Assessed by BICR per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in Participants who are HRD Positive (HRD+) | PFS was defined as the time from first dose of study treatment to the first documented PD or death due to any cause whichever occurred first among participants as assessed by BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria. Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions in total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm or the appearance of ≥1 new lesion; PD confirmation (>4 weeks after initial PD) was required for participants remaining on treatment. Per PCWG, PD was >2 new bone lesions (not tumor flare) persisting >6 weeks. Per protocol, the secondary PFS outcome measure analysis for HRD+ participants in Cohort 1 (BRCA 1/2) and Cohort 2 [(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)] combined is presented. | Up to approximately 78 months |
| Combined Cohort 1+2: PFS as Assessed by BICR per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in All Combined Cohort 1+2 Participants Regardless of Biomarker Status | PFS was defined as the time from first dose of study treatment to the first documented PD or death due to any cause whichever occurred first among participants as assessed by BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria. Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions in total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm or the appearance of ≥1 new lesion; PD confirmation (>4 weeks after initial PD) was required for participants remaining on treatment. Per PCWG, PD was >2 new bone lesions (not tumor flare) persisting >6 weeks. Per protocol, the secondary ORR outcome measure analysis for all participants regardless of biomarker status in Cohort 1 (BRCA 1/2) and Cohort 2 ([HRRm, BRCA Non-mutated]; [HRD+, HRR Non-mutated]) combined is presented. | Up to approximately 78 months |
| Cohort 2: Time to Earliest Progression by Cancer Antigen-125 (CA-125) | Time to earliest progression by CA-125 was defined as the time from first dose to progression by CA-125. For participants with BRCA1/2 non-mutated ovarian cancer only, progression by CA-125 was defined as either CA-125 ≥2× upper limit normal (ULN) on 2 occasions 1 week apart or, for participants with elevated CA-125 (≥ULN) at baseline, ≥2× the nadir value on 2 occasions 1 week apart. Time to earliest progression by CA-125 as assessed is presented. | Up to approximately 78 months |
| Cohort 1 & 2: Prostate-specific Antigen (PSA) Response Rate in Participants with Prostate Cancer | PSA response was defined as a reduction in PSA level ≥50% from baseline measured twice at least 3 weeks apart. For participants with prostate cancer with baseline PSA measurements available, the PSA response rate as assessed is presented. | Up to approximately 78 months |
| Cohort 3: PFS2 as Assessed by the Investigator in Participants with sBRCAm Breast Cancer | PFS2 was defined as the time from the first dose of study medication to subsequent disease progression on next-line treatment or death due to any cause, whichever occurred first, as assessed by the investigator. PFS2 for participants with sBRCAm breast cancer in Cohort 3 is presented. | Up to approximately 78 months |
| St Joseph Heritage Healthcare-Oncology ( Site 0056) |
| Fullerton |
| California |
| 92835 |
| United States |
| Cedars Sinai Medical Center ( Site 0002) | Los Angeles | California | 90048 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007) | San Francisco | California | 94158 | United States |
| Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092) | Aurora | Colorado | 80045 | United States |
| Winship Cancer Institute of Emory University ( Site 0025) | Atlanta | Georgia | 30322-1013 | United States |
| Augusta University ( Site 0028) | Augusta | Georgia | 30912 | United States |
| Markey Cancer Center ( Site 0018) | Lexington | Kentucky | 40536 | United States |
| University of Maryland ( Site 0050) | Baltimore | Maryland | 21201 | United States |
| Weinberg Cancer Institute at Franklin Square ( Site 0054) | Baltimore | Maryland | 21237 | United States |
| University of Massachusetts ( Site 0017) | Worcester | Massachusetts | 01655 | United States |
| Henry Ford Health System ( Site 0060) | Detroit | Michigan | 48202 | United States |
| Cancer Partners of Nebraska ( Site 0051) | Lincoln | Nebraska | 68510 | 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 |
| VA New York Harbor Healthcare System Manhattan ( Site 0094) | New York | New York | 10010 | United States |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057) | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center ( Site 0026) | New York | New York | 10065 | United States |
| Southwestern Regional Medical Center, Inc. ( Site 0079) | Tulsa | Oklahoma | 74133 | United States |
| Eastern Regional Medical Center, Inc. ( Site 0077) | Philadelphia | Pennsylvania | 19124 | United States |
| Sanford Hematology Oncology-Sioux Falls SD ( Site 0012) | Sioux Falls | South Dakota | 57104 | United States |
| Intermountain Healthcare ( Site 0043) | St. George | Utah | 84790 | United States |
| Virginia Mason Medical Center ( Site 0052) | Seattle | Washington | 98101 | United States |
| Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093) | Seattle | Washington | 98108 | United States |
| Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703) | Berazategui | Buenos Aires | B1884BBF | Argentina |
| Hospital Britanico de Buenos Aires ( Site 2704) | Ciudad de Buenos Aires | Buenos Aires F.D. | C1280AEB | Argentina |
| Instituto de Investigaciones Metabolicas ( Site 2700) | Buenos Aires | C1012AAR | Argentina |
| Hospital Aleman ( Site 2702) | Buenos Aires | C1118AAT | Argentina |
| Kinghorn Cancer Centre ( Site 2200) | Darlinghurst | New South Wales | 2010 | Australia |
| MNCCI Port Macquarie Base Hospital ( Site 2201) | Port Macquarie | New South Wales | 2444 | Australia |
| Linear Clinical Research Ltd ( Site 2202) | Nedlands | Western Australia | 6009 | Australia |
| Sunnybrook Research Institute ( Site 0210) | Toronto | Ontario | M4N 3M5 | Canada |
| Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203) | Montreal | Quebec | H1T 2M4 | Canada |
| Jewish General Hospital ( Site 0209) | Montreal | Quebec | H3T 1E2 | Canada |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 | Québec | Quebec | G1J 1Z4 | Canada |
| Fundacion Centro de Investigacion Clinica CIC ( Site 2812) | Medellín | Antioquia | 050021 | Colombia |
| Rodrigo Botero SAS ( Site 2801) | Medellín | Antioquia | 050030 | Colombia |
| Biomelab S A S ( Site 2800) | Barranquilla | Atlántico | 080001 | Colombia |
| Administradora Country SA - Clinica del Country ( Site 2802) | Bogotá | Bogota D.C. | 110221 | Colombia |
| Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2807) | Bogotá | Bogota D.C. | 110311 | Colombia |
| Instituto Nacional de Cancerologia E.S.E ( Site 2809) | Bogotá | Bogota D.C. | 111511 | Colombia |
| Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2808) | Valledupar | Cesar Department | 200001 | Colombia |
| Oncomedica S.A. ( Site 2806) | Montería | Departamento de Córdoba | 230002 | Colombia |
| C. Medico Imbanaco Cali S.A. ( Site 2810) | Cali | Valle del Cauca Department | 760042 | Colombia |
| Rigshospitalet ( Site 0402) | Copenhagen | Capital Region | 2100 | Denmark |
| Herlev og Gentofte Hospital. ( Site 0401) | Herlev | Capital Region | 2730 | Denmark |
| Odense Universitetshospital ( Site 0400) | Odense | Region Syddanmark | 5000 | Denmark |
| CHU Poitiers ( Site 0612) | Poitiers | Ain | 86021 | France |
| Centre Antoine Lacassagne ( Site 0610) | Nice | Alpes-Maritimes | 06189 | France |
| Institut de Cancerologie Strasbourg Europe ( Site 0613) | Strasbourg | Alsace | 67033 | France |
| Centre Georges Francois Leclerc ( Site 0608) | Dijon | Bourgogne-Franche-Comté | 21000 | France |
| Institut Bergonie ( Site 0603) | Bordeaux | Gironde | 33076 | France |
| Institut Gustave Roussy ( Site 0601) | Villejuif | Val-de-Marne | 94805 | France |
| Centro Regional de Sub Especialidades Medicas SA ( Site 3003) | Guatemala | Departamento de Quetzaltenango | 09001 | Guatemala |
| Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 3004) | Guatemala City | 01010 | Guatemala |
| Integra Cancer Institute ( Site 3006) | Guatemala City | 01010 | Guatemala |
| Grupo Angeles SA ( Site 3001) | Guatemala City | 01015 | Guatemala |
| Mater Misericordiae University Hospital ( Site 1654) | Dublin | Carlow | D07 WKW8 | Ireland |
| Bon Secours Hospital ( Site 1656) | Cork | T12 DV56 | Ireland |
| St. Vincent's University Hospital ( Site 1653) | Dublin | 00004 | Ireland |
| Tallaght University Hospital ( Site 1652) | Dublin | D24 NROA | Ireland |
| Soroka Medical Center ( Site 0800) | Beersheba | 8457108 | Israel |
| Rambam Health Care Campus-Oncology Division ( Site 0801) | Haifa | 3109601 | Israel |
| Hadassah Ein Kerem Medical Center ( Site 0802) | Jerusalem | 9112001 | Israel |
| Chaim Sheba Medical Center ( Site 0803) | Ramat Gan | 5262000 | Israel |
| Sourasky Medical Center ( Site 0804) | Tel Aviv | 6423906 | Israel |
| Istituto Nazionale Tumori Fondazione Pascale ( Site 0700) | Naples | Campania | 80131 | Italy |
| Istituto Clinico Humanitas Research Hospital ( Site 0703) | Rozzano | Lombardy | 20089 | Italy |
| Policlinico Le Scotte di Siena ( Site 0704) | Siena | Tuscany | 53100 | Italy |
| Aichi Cancer Center Hospital ( Site 2602) | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East ( Site 2600) | Kashiwa | Chiba | 2778577 | Japan |
| Kyoto University Hospital ( Site 2603) | Kyoto | Kyoto | 606-8507 | Japan |
| Osaka University Hospital ( Site 2604) | Suita | Osaka | 565-0871 | Japan |
| National Cancer Center Hospital ( Site 2601) | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of JFCR ( Site 2605) | Tokyo | 135-8550 | Japan |
| Actualidad Basada en la Investigacion del Cancer ( Site 2903) | Guadalajara | Jalisco | 44680 | Mexico |
| Unidad Biomedica Avanzada Monterrey S. A. ( Site 2902) | Monterrey | Nuevo León | 64460 | Mexico |
| Cuidados Oncologicos ( Site 2908) | Santiago de Quetaro | Querétaro | 76000 | Mexico |
| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2901) | Madero | Tamaulipas | 89440 | Mexico |
| Centro Estatal de Cancerologia de Chihuahua ( Site 2907) | Chihuahua City | 31000 | Mexico |
| CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 2900) | Mexico City | 06100 | Mexico |
| CENEIT Oncologicos ( Site 2904) | México | 03100 | Mexico |
| Oaxaca Site Management Organization S.C. ( Site 2905) | Oaxaca City | 68000 | Mexico |
| Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 3102) | Trujillo | La Libertad | 13006 | Peru |
| Instituto Nacional de Enfermedades Neoplasicas ( Site 3106) | Lima | Muni Metro de Lima | 15038 | Peru |
| Hospital Nacional Guillermo Almenara Irigoyen ( Site 3107) | Lima | 15033 | Peru |
| Clinica Internacional Sede San Borja ( Site 3100) | Lima | 15036 | Peru |
| Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 3101) | Lima | 15036 | Peru |
| Oncosalud-Clinical Research ( Site 3108) | Lima | 15036 | Peru |
| 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 Arzobispo Loayza ( Site 3103) | Lima | 15082 | Peru |
| S.C. Pelican Impex S.R.L Spitalul Clinic Pelican Oradea ( Site 1102) | Oradea | Bihor County | 410469 | Romania |
| Medisprof ( Site 1107) | Cluj-Napoca | Cluj | 400641 | Romania |
| SC Radiotherapy Center Cluj SRL ( Site 1105) | Comuna Floresti | Cluj | 407280 | Romania |
| S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103) | Craiova | Dolj | 200542 | Romania |
| Spitalul PDR Medlife ( Site 1106) | Brasov | 500152 | 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 |
| Arkhangelsk Clinical Oncological Dispensary ( Site 1204) | Arkhangelsk | Arkhangelskaya oblast | 163045 | Russia |
| Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1212) | Chelyabinsk | Chelyabinsk Oblast | 454087 | Russia |
| N.N. Blokhin NMRCO ( Site 1201) | Moscow | Moscow | 115477 | Russia |
| MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1213) | Moscow | Moscow | 125284 | Russia |
| MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1216) | Krasnogorsk | Moscow Oblast | 143442 | Russia |
| Ryazan Regional Clinical Oncology dispensary ( Site 1202) | Ryazan | Ryazan Oblast | 390011 | Russia |
| SBHI Samara Regional Clinical Oncology Dispensary ( Site 1211) | Samara | Samara Oblast | 443031 | Russia |
| Clinical Hospital Saint Luka ( Site 1205) | Saint Petersburg | Sankt-Peterburg | 194044 | Russia |
| SBHI Leningrad Regional Clinical Hospital ( Site 1206) | Saint Petersburg | Sankt-Peterburg | 194291 | Russia |
| Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1208) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 120 | Kazan' | Tatarstan, Respublika | 420029 | 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 |
| Hospital Universitario Quiron Madrid ( Site 1352) | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Universitari Vall d Hebron ( Site 1350) | Barcelona | 08035 | Spain |
| Universitaetsspital Zuerich ( Site 1400) | Zuerich | Canton of Aargau | 8091 | Switzerland |
| Hopitaux Universitaires de Geneve HUG. ( Site 1406) | Geneva | Canton of Geneva | 1211 | Switzerland |
| Ospedale Regionale di Bellinzona e Valli ( Site 1407) | Bellinzona | Canton Ticino | 6500 | Switzerland |
| Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507) | Konya | Adana | 42080 | Turkey (Türkiye) |
| Baskent University Adana Training Hospital ( Site 1508) | Adana | 01250 | Turkey (Türkiye) |
| Hacettepe Universitesi Tıp Fakultesi ( Site 1503) | Ankara | 06100 | Turkey (Türkiye) |
| Akdeniz Universitesi Tip Fakultesi ( Site 1504) | Antalya | 07070 | Turkey (Türkiye) |
| Trakya Universitesi Tip Fakultesi ( Site 1500) | Edirne | 22030 | Turkey (Türkiye) |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1505) | Istanbul | 34098 | Turkey (Türkiye) |
| Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1506) | Istanbul | 34722 | Turkey (Türkiye) |
| Ege Universitesi Tip Fakultesi ( Site 1502) | Izmir | 35100 | Turkey (Türkiye) |
| Churchill Hospital ( Site 1606) | Oxford | Worcestershire | OX3 7LE | United Kingdom |
| Christie NHS Foundation Trust ( Site 1601) | Manchester | M20 4BX | United Kingdom |
| Northern Centre for Cancer Care ( Site 1602) | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Weston Park Hospital ( Site 1607) | Sheffield | S10 2SJ | United Kingdom |
| ID | Term |
|---|---|
| C531550 | olaparib |
Not provided
Not provided
Not provided