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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511957-23 | Other Identifier | European Medicines Agency | |
| GOG-3104 | Other Identifier | The GOG Foundation | |
| ENGOT-en26 | Other Identifier | European Network for Gynaecological Oncological Trial Groups | |
| APGOT-EN2 | Other Identifier | Asia-Pacific Gynecologic Oncology Trials Group |
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| Name | Class |
|---|---|
| GOG Foundation | NETWORK |
| European Network of Gynaecological Oncological Trial Groups (ENGOT) | OTHER |
| Asia-Pacific Gynecologic Oncology Trials Group | OTHER |
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The goal of this clinical study is to find out how the study drug, sacituzumab govitecan (SG) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy, versus the treatment of physician's choice (TPC).
The primary objectives of this study are to evaluate the effect of SG compared to TPC on progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab Govitecan (SG) | Experimental | Participants will receive SG at a dose of 10 mg/kg on Days 1 and 8 of a 21-day cycle. |
|
| Treatment of Physician's Choice (TPC) | Active Comparator | Participants will receive one of the following TPC, regimens determined prior to randomization.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab govitecan-hziy | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) | PFS, defined as the time from the date of randomization until the date of objective progressive disease (PD), as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever comes first. | Up to approximately 27 months |
| Overall Survival (OS) | Overall survival (OS) is defined as time from the date of randomization until death due to any cause. | Up to approximately 47 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as Assessed by BICR | ORR, defined as the percentage of participants who have achieved a CR or PR as best overall response that is confirmed ≥ 4 weeks after initial documentation of response as assessed by BICR per RECIST v1.1. | Up to approximately 47 months |
| Change from Baseline in the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Version 3.0 (EORTC QLQ-C30) at Week 16 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| City of Hope |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41073155 | Derived | Eskander RN, Corr B, Cibula D, Tan DSP, Cloven N, Guerra E, Hasegawa K, Myers T, You B, Makker V, Zagouri F, Gien LT, Bartoletti M, Mallen A, Woelber L, Mocci S, Komatsubara K, Ma L, Colombo N. A randomized, phase III study of sacituzumab govitecan versus treatment of the physician's choice in patients with endometrial cancer after platinum-based chemotherapy and immunotherapy: the ASCENT-GYN-01 study (GOG-3104/ENGOT-en26/APGOT-EN2). Int J Gynecol Cancer. 2026 Jun;36(6):102654. doi: 10.1016/j.ijgc.2025.102654. Epub 2025 Sep 7. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| Doxorubicin | Drug | Administered intravenously |
|
|
| Paclitaxel | Drug | Administered intravenously |
|
|
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. The physical functioning scale range in score from 0 to 100. Higher score denote a better level of functioning (i.e. a better state of the participant). |
| Baseline, Week 16 |
| PFS as Assessed by Investigator | PFS is defined as the time from the date of randomization until the date of objective PD, as assessed by investigator per RECIST v1.1, or death from any cause, whichever comes first | Up to approximately 27 months |
| ORR as Assessed by Investigator | ORR is defined as the percentage of participants who have achieved a CR or PR as best overall response that is confirmed ≥ 4 weeks after initial documentation of response as assessed by investigator per RECIST v1.1 | Up to approximately 47 months |
| Duration of Response (DOR) as Assessed by BICR and Investigator | DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD as assessed by BICR and investigator per RECIST v1.1, or death from any cause, whichever comes first. | Up to approximately 47 months |
| Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator | CBR is defined as the percentage of participants with best overall response of CR or PR that is confirmed ≥ 4 weeks after initial documentation of response or durable stable disease (SD; duration of SD ≥ 6 months from randomization to disease progression), as assessed by BICR and investigator per RECIST v1.1. | Up to approximately 47 months |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | First dose date up to 30 days post last dose (Up to Up to approximately 47 months) |
| Percentage of Participants Experiencing Clinical Laboratory Abnormalities | First dose date up to 30 days post last dose (Up to Up to approximately 47 months) |
| Change from baseline in Global Health Status (GHS)/Quality of Life (QoL) Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Version 3.0 (EORTC QLQ-C30) at Week 16 | The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. Global health status score ranges from 0 to 100. Higher score denote a better level of functioning (i.e. a better state of the participant). | Baseline, Week 16 |
| Duarte |
| California |
| 91010 |
| United States |
| UC San Diego Medical Center | La Jolla | California | 92093 | United States |
| Cedars-Sinai Cancer at Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Stanford Women's Cancer Center | Palo Alto | California | 94304 | United States |
| Kaiser Permanente Medical Center | Vallejo | California | 94589 | United States |
| University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) | Aurora | Colorado | 80045 | United States |
| Hartford HealthCare Cancer Institute at Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | United States |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States |
| Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System | Savannah | Georgia | 31405 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| M Health Fairview University of Minnesota Medical Center - East Bank Hospital | Minneapolis | Minnesota | 55455 | United States |
| Metro Minnesota Community Oncology Research Consortium (MMCORC) | Saint Louis Park | Minnesota | 55426 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| MidAmerica Division, Inc. c/o Research Medical Center | Kansas City | Missouri | 64132 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Rutgers Cancer Institute | New Brunswick | New Jersey | 08901 | United States |
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Northwell Health Cancer Institute | Lake Success | New York | 11042 | United States |
| Columbia University Medical Center, Herbert Irving Pavilion | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | United States |
| Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa | Tulsa | Oklahoma | 74146 | United States |
| Providence Cancer Institute Franz Clinic | Portland | Oregon | 97213 | United States |
| Alliance Cancer Specialists, PC | Horsham | Pennsylvania | 19044 | United States |
| University of Pennsylvania Health System, Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| MUSC Hollings Cancer Center | Charleston | South Carolina | 29485 | United States |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Texas Oncology | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine Medical Center | Houston | Texas | 77030 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Virginia Comprehensive Cancer Center | Charlottesville | Virginia | 22908 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
| Froedtert and the Medical College of Wisconsin (MCW) | Milwaukee | Wisconsin | 53226 | United States |
| Canberra Hospital | Canberra | Australian Capital Territory | 2605 | Australia |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Mater Cancer Care Centre | South Brisbane | Queensland | 4101 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Sir Charles Gairdner Hospital | Murdoch | Western Australia | 6150 | Australia |
| Clínica de Neoplasias Litoral | Itajaí | 88301-220 | Brazil |
| Centro de Pesquisa Clínica do Hospital Moinhos de Vento | Porto Alegre | 90035001 | Brazil |
| Hospital Santa Joana Recife | Recife | 52011906 | Brazil |
| Instituto D'Or Pesquisa e Ensino | Rio de Janeiro | 22281-100 | Brazil |
| Ensino e Terapia de Inovação Clínica AMO - ETICA | Salvador | 41950640 | Brazil |
| Instituto do Câncer do Estado de São Paulo | São Paulo | 01246-000 | Brazil |
| BP - A Beneficência Portuguesa da São Paulo / Hospital BP Mirante | São Paulo | 01321-001 | Brazil |
| DASA - Hospital 9 de Julho | São Paulo | 01409-002 | Brazil |
| AC Camargo Cancer Center (Fundação Antonio Prudente) | São Paulo | 01509-900 | Brazil |
| Arthur J. E. Child Comprehensive Cancer Centre | Calgary | T2N 5G2 | Canada |
| London Health Sciences Centre | London | N6A 5W9 | Canada |
| McGill University Health Centre - Glen Site | Montreal | H4A 3J1 | Canada |
| CIC-CHU de Québec-Université Laval- Hôpital de l'Enfant-Jésus | Québec | G1G 5X1 | Canada |
| Sunnybrook Research Institute | Toronto | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre | Toronto | M5G 2M9 | Canada |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| Hunan Cancer Hospital | Changsha | 410013 | China |
| West China Second Hospital of Sichuan University | Chengdu | 610041 | China |
| Chongqing University Cancer Hospital | Chongqing | 400030 | China |
| Guangxi Medical University Affiliated Tumor Hospital | Guangxi Zhuang Autonomous Region | 530021 | China |
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Guangzhou | 61020 | China |
| Women's Hospital School Of Medicine Zhejiang University | Hangzhou | 310006 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Jiangxi Maternal and Child Health Hospital | Nanchang | 330006 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Shanghai Tenth People's Hospital | Shanghai | 200072 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | 300060 | China |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | 430022 | China |
| Tongji Hospital, Tongji Medical College of HUST | Wuhan | 430030 | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | 710061 | China |
| Henan Cancer Hospital | Zhengzhou | 450003 | China |
| Nemocnice AGEL, Nový Jičín a.s. | Nový Jičín | 74101 | Czechia |
| University Hospital Ostrava | Ostrava-Poruba | 708 52 | Czechia |
| General University Hospital in Prague | Prague | 128 08 | Czechia |
| University Hospital Bulovka | Prague | 180 81 | Czechia |
| Centre Francois Baclesse | Caen | 14076 | France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hôpital Cochin | Paris | 75014 | France |
| HCL - Centre Hospitalier Lyon Sud | Pierre-Bénite | 69130 | France |
| ICO - Centre René Gauducheau | Saint-Herblain | 44805 | France |
| Institut de Cancerologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Hochtaunus Kliniken Bad Homburg | Bad Homburg | 61352 | Germany |
| Universitatsklinikum Dusseldorf | Düsseldorf | 40225 | Germany |
| University Hospital Essen | Essen | 45147 | Germany |
| Universitätsklinikum Hamburg | Hamburg | 20246 | Germany |
| Medical School Hannover | Hanover | 30625 | Germany |
| University Hospital Leipzig | Leipzig | 04103 | Germany |
| Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde | München | 81675 | Germany |
| Universitätsklinikum Ulm | Ulm | 89075 | Germany |
| Aretaeion Hospital | Athens | 11528 | Greece |
| MITERA hospital | Athens | 15123 | Greece |
| Kalamata Hospital | Kalamata | 241 00 | Greece |
| General Hospital of Patras Agios Andreas | Pátrai | 26335 | Greece |
| St. Luke's Hospital | Thessaloniki | 55236 | Greece |
| Hong Kong Sanatorium & Hospital | Happy Valley | 999077 | Hong Kong |
| Queen Mary Hospital | Hong Kong | 999077 | Hong Kong |
| Prince of Wales Hospital | New Territories | 999077 | Hong Kong |
| Hillel Yaffe Medical Center | Hadera | 3810101 | Israel |
| Rambam Health Care Campus | Haifa | 3501602 | Israel |
| Wolfson Medical Center | Holon | 58100 | Israel |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Sourasky T.A.M.C. | Tel Aviv | 6423906 | Israel |
| SOC di Oncologia Medica e Prevenzione Oncologica Centro di Riferimento Oncologico di Aviano (CRO) IRCCS | Aviano | 33081 | Italy |
| Azienda Ospedaliera Universitaria Careggi - Unita di Oncologia Ginecologica | Florence | 50134 | Italy |
| ASST Lecco - Ospedale Alessandro Manzoni | Lecco | 23900 | Italy |
| Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST | Meldola | 47014 | Italy |
| Irccs Ospedale San Raffaele-UO Ginecologia | Milan | 20132 | Italy |
| Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano | Milan | 20133 | Italy |
| Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Istituto Oncologico Veneto IRCCS | Padova | 35128 | Italy |
| Azienda Ospedaliero Universitaria Pisana, Ospedale Santa Chiara | Pisa | 56126 | Italy |
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma | 168 | Italy |
| Istituto Nazionale Tumori Regina Elena IRCCS | Rome | 00 144 | Italy |
| AOU Città della Salute e della Scienza di Torino - Presidio Sant'Anna | Torino | 10126 | Italy |
| A.O. Ordine Mauriziano di Torino | Torino | 10128 | Italy |
| Chiba Cancer Center | Chiba | 260-8717 | Japan |
| The Jikei University Kashiwa Hospital | Chiba | 277-8567 | Japan |
| Hyogo Cancer Center | Hyōgo | 673-8558 | Japan |
| St. Marianna University Hospital | Kanagawa | 216-8511 | Japan |
| Mie University Hospital | Mie | 514-8507 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Saitama Medical University International Medical Center | Saitama | 350-1241 | Japan |
| Shizuoka Cancer Center | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital Of JFCR | Tokyo | 135-8550 | Japan |
| Szpitale Pomorskie Sp. z o.o. | Gdynia | 81-519 | Poland |
| Uniwersyteckie Centrum Kliniczne SUM | Katowice | 50-752 | Poland |
| Oddział Ginekologii Onkologicznej Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | 60-569 | Poland |
| Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach | Siedlce | 08-110 | Poland |
| Dolnoslaskie Centrum Onkologii | Wroclaw | 53-413 | Poland |
| National University Hospital | Singapore | 119074 | Singapore |
| National Cancer Centre Singapore | Singapore | 168583 | Singapore |
| Keimyung University Dongsan Medical Center | Dalseo-gu | 41931 | South Korea |
| National Cancer Center - Korea | Goyang-si | 10408 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Severance Hospital | Seoul | 0 | South Korea |
| Complexo Hospitalario Universitario A Coruna | A Coruña | 15007 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Ciudad de Jaen | Jaén | 23007 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28009 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 2910 | Spain |
| Hospital Universitari Son Espases | Palma | 07120 | Spain |
| Hospital Parc Taulí | Sabadell | 08208 | Spain |
| Hospital Universitario Donostia | San Sebastián | 20014 | Spain |
| Hospital Universitario La Fe - Valencia | Valencia | 46026 | Spain |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 813 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Mackay Memorial Hospital | Taipei | 104 | Taiwan |
| Chang Gung Memorial Hospital, Linkou | Taoyuan City | Taiwan |
| Birmingham Heartlands Hospital | Birmingham | B75 7RR | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
| University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| University College London Hospitals | London | NW1 2PG | United Kingdom |
| East and North Hertfordshire NHS Trust - Mount Vernon Cancer Centre | Northwood | HA6 2RN | United Kingdom |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000608132 | sacituzumab govitecan |
| D004317 | Doxorubicin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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