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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031250064 | Registry Identifier | Japan Registry for Clinical Trials (jRCT) | |
| CTR20253987 | Registry Identifier | ChinaDrugTrials.org.cn | |
| PRO1184-002 | Other Identifier | Other Sponsor Identifier | |
| GOG-3107 | Other Identifier | Other Sponsor Identifier | |
| ENGOT-OV86 | Other Identifier | Other Sponsor Identifier | |
| 2024-514822-21 | Other Identifier | EU Trial (CTIS) Number |
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This phase 3 study will be conducted in different countries all over the world.
The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.
Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.
All participants will receive active drug; no one will be given placebo.
The China extension-study of GCT1184-02 is registered under NCT07604766.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rina-S | Experimental |
| |
| Investigator's Choice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rina-S | Drug | Intravenous (IV) infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator. | Up to approximately 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from date of randomization to date of death due to any cause. | Up to approximately 1.5 years |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator. |
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Key Inclusion Criteria:
Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Participants may be enrolled regardless of FRα expression level.
Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
Participants must have received prior treatment with the following therapies:
Platinum chemotherapy
Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance
Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor
Mirvetuximab soravtansine, if:
Participants must have platinum-resistant disease:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Official | Genmab | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Women's Cancer Care | Anchorage | Alaska | 99508 | United States | ||
| Arizona Center for Cancer Care (ACCC) - Biltmore |
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| Paclitaxel | Drug | IV infusion |
|
| Topotecan | Drug | IV infusion |
|
| Pegylated liposomal doxorubicin (PLD) | Drug | IV infusion |
|
| Gemcitabine | Drug | IV infusion |
|
| Up to approximately 1.5 years |
| PFS as Determined by BICR | PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on RECIST version 1.1 as determined by BICR. | Up to approximately 1.5 years |
| ORR as Determined by BICR | ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR. | Up to approximately 1.5 years |
| Duration of Response (DOR) | DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator and by blinded independent central review (BICR). | Up to approximately 1.5 years |
| Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria | A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline. | Up to approximately 1.5 years |
| Time to Second Disease Progression or Death From any Cause (PFS2) | PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death. | Up to approximately 1.5 years |
| Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) | Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire. The score ranges from 0 to 100. A high scale score represents a higher response level. | Baseline, up to approximately 1.5 years |
| Time to Deterioration (TTD) in the GHS/Qol Score | TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score. A longer TTD indicates a better outcome. | Up to approximately 1.5 years |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 1.5 years |
| Change from Baseline in Electrocardiogram (ECG) Findings to Assess Changes in QTc Associated with Rina-S by Holter Monitor | Baseline through Cycle 3 (Cycle length=21 days) |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| University of Arizona Cancer Center - Research and Administration at Main Campus | Tucson | Arizona | 85724 | United States |
| Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center | Burbank | California | 91505 | United States |
| University of California San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| USCF Mission Bay | San Francisco | California | 94158 | United States |
| Kaiser Permanente - Vallejo Medical Center | Vallejo | California | 94589 | United States |
| UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
| Norwalk Hospital | Norwalk | Connecticut | 06850 | United States |
| SCRI - Florida Cancer Specialists - South Region Research Office | Fort Myers | Florida | 33901-8108 | United States |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States |
| Orlando Health Cancer Institute - Downtown Orlando | Orlando | Florida | 32806 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| SCRI - Florida Cancer Specialists - West Palm Beach | West Palm Beach | Florida | 33401 | United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| Northside Hospital Atlanta | Atlanta | Georgia | 30342 | United States |
| Augusta University Georgia Cancer Center | Augusta | Georgia | 30912 | United States |
| Kapi'olani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Northwest Cancer Center - Dyer | Dyer | Indiana | 46311 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| HCA Midwest Health | Overland Park | Kansas | 66211 | United States |
| St. Elizabeth Healthcare - Edgewood | Edgewood | Kentucky | 41017 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Louisiana State University Health Sciences Center (LSU Health) - New Orleans | New Orleans | Louisiana | 70112 | United States |
| Trials365, LLC (Gynecologic Oncology Associates-Shreveport) | Shreveport | Louisiana | 71103 | United States |
| Maine Medical Center Cancer Institute- Scarborough | Scarborough | Maine | 04074-7172 | United States |
| Holy Cross Health - Holy Cross Hospital | Silver Spring | Maryland | 20910 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Corewell Health (Spectrum Health) | Grand Rapids | Michigan | 49503 | United States |
| Saint Joseph Mercy Ann Arbor Hospital | Ypsilanti | Michigan | 48197 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | United States |
| Center of Hope | Reno | Nevada | 89511 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131 | United States |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14203 | United States |
| Perlmutter Cancer Center - 38th Street | New York | New York | 10016 | United States |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island | New York | New York | 10016 | United States |
| Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| New York-Presbyterian - Weill Cornell Medical Center | New York | New York | 10065 | United States |
| James P. Wilmot Cancer Center | Rochester | New York | 14642 | United States |
| Duke Cancer Institute | Durham | North Carolina | 27705 | United States |
| FirstHealth Outpatient Cancer Center | Pinehurst | North Carolina | 28374 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | United States |
| JamesCare Gynecologic Oncology at Mill Run | Hilliard | Ohio | 43026 | United States |
| Legacy Good Samaritan Medical Center | Portland | Oregon | 97210 | United States |
| USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center | Portland | Oregon | 97227 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Allegheny Health Network - West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Jefferson Health - Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | United States |
| USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene | Abilene | Texas | 79606 | United States |
| USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central | Austin | Texas | 78731 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | United States |
| USOR - Virginia Oncology Associates - Norfolk | Norfolk | Virginia | 23502 | United States |
| Kadlec Clinic - Hematology and Oncology | Kennewick | Washington | 99336 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| West Virginia University Cancer Institute | Morgantown | West Virginia | 26506-9600 | United States |
| University of Wisconsin - Madison | Madison | Wisconsin | 53706 | United States |
| Newcastle Private Hospital | New Lambton Heights | New South Wales | Australia |
| Icon Cancer Centre | South Brisbane | Queensland (qld) | 4101 | Australia |
| Mater Misericordiae - Mater Hospital Brisbane | South Brisbane | Australia |
| Saint John of God - Subiaco Hospital | Subiaco | 6008 | Australia |
| Medizinische Universität Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
| Ordensklinikum Linz GmbH Barmherzige Schwestern | Linz | Upper Austria (Oberösterreich) | 4010 | Austria |
| Medizinische Universität Graz | Graz | 8036 | Austria |
| Medizinische Universität Wien | Vienna | 1090 | Austria |
| Krankenhaus Hietzing | Vienna | 1130 | Austria |
| Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth | Turnhout | Antwerp | 2300 | Belgium |
| AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst | Aalst | 9300 | Belgium |
| Centre Hospitalier Universitaire Saint-Pierre | Brussels | 1000 | Belgium |
| Grand Hôpital de Charleroi - Site Les Viviers | Charleroi | 6000 | Belgium |
| Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| Centre Hospitalier Chretien - Clinique MontLégia | Liège | 4000 | Belgium |
| Algemeen Ziekenhuis Delta - Campus Rumbeke | Roeselare | 051237111 | Belgium |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G2M9 | Canada |
| Centre Hospitalier de l'Université de Montréal (CHUM) | Montreal | Quebec | H2X0C1 | Canada |
| Sunnybrook Health Sciences Centre - Bayview Campus | Toronto | M4Y 3M5 | Canada |
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710049 | China |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| Zhejiang Cancer Hospital | Hanzhou | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | 300060 | China |
| Henan Cancer Hospital - Zhengzhou University | Zhengzhou | China |
| Masaryk Memorial Cancer Institute | Brno | 60200 | Czechia |
| Fakultní Nemocnice Hradec Králové | Hradec Králové | 50005 | Czechia |
| Nemocnice AGEL Nový Jičín a.s. | Nový Jičín | 74101 | Czechia |
| Vseobecna Fakultni Nemocnice v Praze | Prague | 12808 | Czechia |
| Fakultni nemocnice v Motole | Prague | 15000 | Czechia |
| Bulovka University Hospital | Prague | 18000 | Czechia |
| University Hospital Královské Vinohrady | Prague | Czechia |
| Aalborg Universitetshospital | Aalborg | 9000 | Denmark |
| The Royal Hospital (Rigshospitalet) | Copenhagen | Denmark |
| Odense Universitets Hospital | Odense | 5000 | Denmark |
| Centre Antoine Lacassagne | Nice | 6189 | France |
| Hôpital Européen Georges-Pompidou | Paris | 75015 | France |
| Hospital Lyon-Sud (HCL) | Pierre-Bénite | 69310 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| Western Cancer Institute - Saint-Herblain - René Gauducheau Site | Saint-Herblain | 44800 | France |
| Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole | Toulouse | 31059 | France |
| Gustave Roussy | Villejuif | 94805 | France |
| Helios Klinikum Berlin-Buch | Berlin | 13125 | Germany |
| University Hospital Bonn | Bonn | 53127 | Germany |
| University Hospital Carl Gustav Carus Dresden | Dresden | 01307 | Germany |
| University Hospital of Düsseldorf | Düsseldorf | 40225 | Germany |
| Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung | Essen | 45136 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universität | Frankfurt | 60596 | Germany |
| Universitätsklinikum Gießen und Marburg - Gießen (UKGM) | Giessen | 35392 | Germany |
| Mammazentrum Hamburg am Krankenhaus Jerusalem | Hamburg | 20357 | Germany |
| MVZ Onko Medical GmbH Hanover | Hanover | 30449 | Germany |
| University Hospital Heidelberg /Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| UniversitY Hospital of Saarland | Homburg | 66421 | Germany |
| Red Cross Hospital Munich | Munich | 80634 | Germany |
| Universitätsklinikum Münster/University Clinic Muenster | Münster | 48149 | Germany |
| Helios Dr. Horst Schmidt Kliniken Wiesbaden | Wiesbaden | 65199 | Germany |
| General Hospital of Athens | Athens | 11527 | Greece |
| Attikon University General Hospital/General Hospital of West Attica | Chaïdári | 12462 | Greece |
| Aretaieio Hospital | Léfkos | 2024 | Greece |
| Saint Luke's Hospital | Panórama | Greece |
| Azienda Sanitaria Locale Brindisi | Brindisi | Apulia | 72100 | Italy |
| Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele | Milan | 20132 | Italy |
| Istituto Europeo di Oncologia/ European Institute of Oncology | Milan | 20141 | Italy |
| Humanitas San Pio X | Milan | 20159 | Italy |
| Local Health Authority of Biella - Nuovo Ospedale degli Infermi | Ponderano | 13875 | Italy |
| Agostino Gemelli University Hospital Foundation IRCCS | Roma | 00168 | Italy |
| Centre Antoine Lacassagne/Azienda Ospedaliera Ordine Mau | Torino | 10128 | Italy |
| Aichi Cancer Center | Nagoya | Aichi Pref | 4648681 | Japan |
| Kurume University Hospital | Kurume | Fukuoka Pref | 8300011 | Japan |
| Hokkaido Cancer Center | Sapporo | Hokkaido | 0300804 | Japan |
| St. Marianna University Hospital | Kawasaki | Kanagawa Pref | 2160015 | Japan |
| Tohoku University Hospital | Sendai | Miyagi Pref | 9808574 | Japan |
| Niigata University Medical and Dental Hospital | Niigata | Niigata Pref | 9518520 | Japan |
| Okayama University Hospital | Okayama | Okayama Pref. | 7008558 | Japan |
| Saitama Medical University - International Medical Center | Hidaka | Saitama Pref. | 350-1298 | Japan |
| Shizuoka Cancer Center | Nagaizumi-chō | Shizuoka Pref. | 4118777 | Japan |
| Jichi Medical University Hospital | Saitama | Tochigi Pref. | 329-0498 | Japan |
| The Jikei University Hospital | Minato | Tokyo | 105-0003 | Japan |
| Ehime University Hospital | Shibukawa | Toon City, Ehime Pref | 791-0295 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Amsterdam UMC, location VUmc | Amsterdam | 1081 HV | Netherlands |
| Medisch Spectrum Twente - Enschede Koningsplein | Enschede | 7512 AV | Netherlands |
| Leids Universitair Medisch Centrum (LUMC) | Leiden | 2333 | Netherlands |
| Maastricht (UMC) Universitair Medisch Centrum | Maastricht | 6229 | Netherlands |
| Erasmus MC/ Erasmus Medisch Centrum | Rotterdam | 3015 GD | Netherlands |
| Oslo Universitetssykehus - Radiumhospitalet | Oslo | 0379 | Norway |
| University Hospital of North Norway/Universitetssykehuset Nord-Norge - Tromsø | Tromsø | 9019 | Norway |
| Jagiellońskie Centrum Innowacj | Krakow | Lesser Poland (Małopolskie) | 30-348 | Poland |
| Białostockie Centrum Onkologii im. Marii Skłodowskiej- Curie w Białymstoku | Bialystok | 15-027 | Poland |
| Uniwersyteckie Centrum Kliniczne w Gdańsku | Gdansk | 80-211 | Poland |
| Instytut Centrum Zdrowia Matki Polki | Lodz | 93-338 | Poland |
| Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie | Poznan | 61-867 | Poland |
| Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach | Siedlce | 08-110 | Poland |
| Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie | Szczecin | 70-111 | Poland |
| UPR Comprehensive Cancer Center Hospital | Monacillo | San Juan | 00927 | Puerto Rico |
| Hospital Universitario de A Coruña | A Coruña | 15006 | Spain |
| Hospital Universitario DE Donostia | Donostia / San Sebastian | 20014 | Spain |
| Hospital Clínico Universitario Virgen de la Arrixaca | El Palmar | 30120 | Spain |
| Hospital Universitario La Paz | Madrid | 28029 | Spain |
| MD Anderson Cancer Center Madrid | Madrid | 28033 | Spain |
| Virgen del Rocío University Hospital | Seville | 41013 | Spain |
| IVO - Valencian Institute of Oncology Foundation | Valencia | 46009 | Spain |
| Miguel Servet Hospital | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| C506643 | liposomal doxorubicin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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