Study Stopped
The Sponsor has discontinued the development of tesetaxel
Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
CONTESSA
A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane
1 other identifier
interventional
685
18 countries
198
Brief Summary
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). 685 patients were enrolled.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Dec 2017
Shorter than P25 for phase_3 breast-cancer
198 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedStudy Start
First participant enrolled
December 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2021
CompletedJuly 30, 2021
July 1, 2021
2.7 years
October 13, 2017
July 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS as assessed by the IRC
Approximately 2.5-3.0 years
Secondary Outcomes (6)
OS
Approximately 5.0-5.5 years
ORR as assessed by the IRC
Approximately 2.5-3.0 years
DCR as assessed by the IRC
Approximately 2.5-3.0 years
Central nervous system (CNS) ORR as assessed by the CNS IRC in patients with CNS metastases at baseline
Approximately 2.5-3.0 years
CNS PFS as assessed by the CNS IRC in patients with CNS metastases at baseline or a history of CNS metastases and in the intent-to-treat (ITT) population
Approximately 2.5-3.0 years
- +1 more secondary outcomes
Other Outcomes (6)
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status/QoL
Approximately 2.5-3.0 years
EORTC QLQ-C30 Functional Scales and Symptom Scales/Items
Approximately 2.5-3.0 years
Adverse events, including deaths and other serious adverse events
Approximately 5.0-5.5 years
- +3 more other outcomes
Study Arms (2)
Arm A: Tesetaxel (oral) and capecitabine (oral)
EXPERIMENTALTesetaxel (27 mg/m2) once every 21 days on Day 1 of each 21-day cycle; and capecitabine (825 mg/m2) twice daily (in the morning and evening after a meal, for a total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Arm B: Capecitabine (oral)
ACTIVE COMPARATORCapecitabine (1,250 mg/m2) twice daily (in the morning and evening after a meal, for a total daily dose of 2,500 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Interventions
Tesetaxel plus reduced dose of Capecitabine
Eligibility Criteria
You may qualify if:
- Female or male patients at least 18 years of age
- Histologically or cytologically confirmed breast cancer
- HER2 negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status
- HR (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\]) positive disease based on local testing: ASCO/CAP guidelines should be utilized for assessing HR status
- Measurable disease per RECIST 1.1 or bone-only disease with lytic component
- Patients with bone-only metastatic cancer must have a lytic or mixed lytic-blastic lesion that can be accurately assessed by computerized tomography (CT) or magnetic resonance imaging (MRI). Patients with bone-only disease without a lytic component (ie, blastic-only metastasis) are not eligible.
- Known metastases to the CNS are permitted but not required. The following criteria apply:
- Patients must be neurologically stable and either off corticosteroids or currently treated with a maximum daily dose of 4 mg of dexamethasone (or equivalent), with no increase in corticosteroid dose within 7 days prior to randomization
- Patients with a history of CNS metastases but with no current evidence of CNS lesions following local therapy are eligible
- Patients may have CNS metastases that are stable or progressing radiologically
- Patients with current evidence of leptomeningeal disease are not eligible
- Patients may have untreated brain metastases or previously treated brain metastases, as long as no immediate local CNS-directed therapy is indicated
- Any prior whole brain radiation therapy must have been completed \> 14 days prior to the date of randomization
- Prior stereotactic brain radiosurgery is permitted
- CNS surgical resection must have been completed \> 28 days prior to the date of randomization; patient must have complete recovery from surgery
- +25 more criteria
You may not qualify if:
- Two or more prior chemotherapy regimens for advanced disease
- Prior treatment with a taxane in the metastatic setting
- Prior treatment with capecitabine at any dose
- Current evidence of leptomeningeal disease
- Other cancer that required therapy within the preceding 5 years other than adequately treated: (a) non-melanoma skin cancer or in situ cancer; or (b) following approval by the Medical Monitor, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the study
- Known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.
- Active hepatitis B or active hepatitis C infection
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
- Presence of neuropathy \> Grade 1 per NCI CTCAE version 5.0
- History of hypersensitivity to taxanes; hypersensitivity to the solvent does not preclude patient participation in this study
- Anticancer treatment, including endocrine therapy, radiotherapy (except stereotactic brain radiosurgery), chemotherapy, biologic therapy, or therapy in an investigational clinical study, ≤ 14 days prior to the date of randomization
- Major surgery ≤ 28 days prior to the date of randomization; patient must have complete recovery from surgery
- Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage or food that is a known clinically relevant strong inhibitor or known clinically relevant inducer of the cytochrome P450 (CYP) 3A pathway (patients should discontinue taking any regularly taken medication that is a strong inhibitor or inducer of the CYP3A pathway)
- History of hypersensitivity or unexpected reactions to capecitabine, other fluoropyrimidine agents or any of their ingredients
- Known dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for DPD deficiency must be performed where required by local regulations, using a validated method that is approved by local health authorities.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (207)
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224, United States
Cancer Treatment Centers of America - Western Regional Medical Center
Goodyear, Arizona, 85338, United States
Arizona Oncology Associates, P.C. - HOPE
Tucson, Arizona, 85704, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
Carti Cancer Center
Little Rock, Arkansas, 72205, United States
Pacific Cancer Medical Center
Anaheim, California, 92801-1824, United States
CBCC Global Research, Inc.
Bakersfield, California, 93309, United States
Compassionate Care Research Group
Fountain Valley, California, 92708, United States
California Cancer Associates for Research and Excellence
Fresno, California, 93720, United States
St. Joseph Heritage Healthcare
Fullerton, California, 92835, United States
UCLA Medical Center
Los Angeles, California, 90024, United States
Cancer Care - Torrance Memorial Physician Network
Redondo Beach, California, 90277, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
San Luis Obispo Oncology & Hematology Health Center
San Luis Obispo, California, 93401, United States
California Cancer Associates for Research and Excellence
San Marcos, California, 92069, United States
Cancer Research Collaboration and Breast Link
Santa Ana, California, 92705, United States
Stanford Cancer Center / Cancer Clinical Trials
Stanford, California, 94304, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Rocky Mountain Cancer Center
Lakewood, Colorado, 80228, United States
Western Connecticut Health Network
Danbury, Connecticut, 06810, United States
Hartford Healthcare
Hartford, Connecticut, 06106, United States
Sarah Cannon Research Institute - Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Florida Cancer Affiliates - Ocala
Ocala, Florida, 34471, United States
Orlando Health
Orlando, Florida, 32806, United States
University of Miami Sylvester Comprehensive Cancer Center / Sylvester at Plantation
Plantation, Florida, 33324, United States
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists and Research Institute - Panhandle Region
Tallahassee, Florida, 32308, United States
Florida Cancer Specialists and Research Institute
West Palm Beach, Florida, 33401, United States
University Cancer and Blood Center
Athens, Georgia, 30607, United States
Cancer Treatment Centers of America
Newnan, Georgia, 30265, United States
University of Chicago Medical Center - Duchossois Center for Advanced Medicine (DCAM)
Chicago, Illinois, 60637, United States
Orchard Healthcare Research
Skokie, Illinois, 60077, United States
American Health Network
Indianapolis, Indiana, 46260, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
SMHC Cancer Care and Blood Disorders
Biddeford, Maine, 04005, United States
University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
GBMC Cancer Center
Baltimore, Maryland, 21204, United States
Chevy Chase Health Care Center/ RCCA
Chevy Chase, Maryland, 20815, United States
James M. Stockman Cancer Institute
Frederick, Maryland, 21702, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, 20850, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503, United States
Virginia Piper Cancer Institute, Allina Health
Minneapolis, Minnesota, 55407, United States
Forrest General Cancer Center/Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Jackson Oncology Associates
Jackson, Mississippi, 39202, United States
Mercy Cancer Center
Joplin, Missouri, 64804, United States
HCA Midwest Health
Kansas City, Missouri, 64131, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital St. Louis, David C. Pratt Cancer Center
St Louis, Missouri, 63141, United States
St. Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Oncology Hematology West, P.C. dba Nebraska Cancer Specialists
Papillion, Nebraska, 68046, United States
New Jersey Hematology Oncology Associates
Brick, New Jersey, 08724, United States
Regional Cancer Care Associates
East Brunswick, New Jersey, 08816, United States
The Valley Hospital
Ridgewood, New Jersey, 07451, United States
Regional Cancer Care Associates, LLC-Sparta
Sparta, New Jersey, 07871, United States
New Mexico Cancer Care Alliance - Southwest Gynecology Oncology
Albuquerque, New Mexico, 87131, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
New York Cancer and Blood Specialists
East Setauket, New York, 11733, United States
Hematology Oncology Associates of Central New York, P.C.
East Syracuse, New York, 13057, United States
Broome Oncology, LLC
Johnson City, New York, 13790, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of North Carolina Lineberger Cancer Center
Chapel Hill, North Carolina, 27599, United States
Ohio State University Comprehensive Cancer Center, Stephanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212, United States
Mercy Clinic Oncology and Hematology
Oklahoma City, Oklahoma, 73120, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Cancer Treatment Centers of America - Philadelphia
Philadelphia, Pennsylvania, 19124, United States
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15601, United States
West Cancer Center
Germantown, Tennessee, 38138, United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, 37203, United States
Texas Oncology - Bedford
Bedford, Texas, 76022, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, 75230, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology - Memorial City
Houston, Texas, 77024, United States
Westside Surgical Hospital and Breast Center
Houston, Texas, 77024, United States
Oncology Consultants
Houston, Texas, 77030, United States
Hope Cancer Center of East Texas
Tyler, Texas, 75701, United States
Bon Secours St. Francis
Midlothian, Virginia, 23114, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Cancer Institute
Richmond, Virginia, 23226, United States
Overlake Medical Center
Bellevue, Washington, 98004, United States
Kadlec Regional Medical Center
Kennewick, Washington, 99336, United States
Swedish Cancer Center
Seattle, Washington, 98104, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Border Medical Oncology
Albury, New South Wales, 2640, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076, Australia
Mater Cancer Care Centre
South Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199, Australia
Breast Cancer Research Centre
Nedlands, Western Australia, Australia
St. John of God Subiaco Hospital
Perth, Western Australia, Australia
Flinders Medical Centre
Bedford Park, Australia
Universitätsklinik Onkologie Landeskkrankenhaus
Salzburg, Austria
Facharzt für Frauenheilkunde und Geburtshilfe Spezialist für Brustchirurgie und Brustkrebs
Schwaz, Austria
Ludwig Boltzmann Institut fur Klinische Onkologie und Photodynamische Therapie
Vienna, 1130, Austria
AKH-Frauenheilkunde
Vienna, Austria
AZ Klina AUGUSTIJNSLEI
Antwerp, 02930, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
UZA
Edegem, 2900, Belgium
UZ Leuven
Leuven, Belgium
CHC-Sant Joseph Oncology-Hematology
Liège, 4000, Belgium
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
QEII Health Sciences Centre - Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 4B3, Canada
Center Hospitalier de Montreal CHUM McPeak Sirois
Montreal, Quebec, H2X 3E4, Canada
CIUSSS de Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital
Montreal, Quebec, H3T IE2, Canada
McGill University Health Center
Montreal, Quebec, H4J 3J1, Canada
Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre
Sherbrooke, Quebec, J1H 5N4, Canada
CHU de Quebec-University Laval
Québec, G1S 4L8, Canada
NH Hospital a.s. Nemocnice Hořovice Onkologie
Hořovice, Czechia
Onkologicka Klinika FN Olomouc
Olomouc, 779 00, Czechia
Onkologicka Klinika (Vseobecna Fakultni Nemocnici v Praze )
Prague, 128 08, Czechia
Onkologicka Klinika (Fakultni Nemocnice v Motole)
Prague, 150 06, Czechia
CHRU J. Minjoz Service Oncologie
Besançon, France
Centre François Baclesse Service the Recherche Clinique
Caen, 14076, France
Hospices Civils de Lyon Sud Oncologie Medicale
Pierre-Bénite, 69310, France
Centre Eugène Marquis
Rennes, 44229, France
Institut Curie - Hopital Rene Huguenin
Saint-Cloud, 92210, France
Clinique Sainte Anne - Strasbourg Oncologie Liberale
Strasbourg, 67085, France
Centre Hospitalier Regional et Universitaire de Tours CHRU
Tours, 37044, France
St. Elisabeth-Krankenhaus GmbH
Cologne, North Rhine-Westphalia, 50935, Germany
InVO - Institut für Versorgungsforschung
Koblenz, Rhineland-Palatinate, 56068, Germany
St. Elisabethgruppe GmbH Marien Hospital Witten Brustzentrum
Witten, Rhineland-Palatinate, 58452, Germany
Arzt der Studienzentrale Universitätsklinikum Erlangen
Erlangen, State of Berlin, 91054, Germany
Charité Universitätsmedizin Berlin-Campus Benjamin Franklin Klinik für Hämatologie, Onkologie und Tumorimmunologie
Berlin, 12203, Germany
Helios Klinikum Berlin-Buch
Berlin, 13125, Germany
Mammazentrum HH am Krankenhaus Jerusalem
Hamburg, 20357, Germany
UKSH, Campus Kiel Klinik für Gynäkologie und Geburtshilfe
Kiel, 24015, Germany
Staedtisches Klinikum Lueneburg gGmbH Brustzentrum und gynaekologisches Krebszentrum der Frauenklinik
Lüneburg, 21339, Germany
LMU Klinikum der Universität München Breast Cancer
München, 80366, Germany
Technische Universität München Klinikum rechts der Isar Klinik und Poliklinik für Frauenheilkunde
München, 81675, Germany
Military Hospital State Health Center
Budapest, Hungary
Országos Onkológiai Intézet
Budapest, Hungary
Semmelweis University
Budapest, Hungary
Uzsoki utcai kórház
Budapest, Hungary
Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz
Nyíregyháza, Hungary
University of Pécs Department of Oncotherapy
Pécs, 7624, Hungary
Ospedale San Raffaele - Medical Oncology Dept.
Milan, 20132, Italy
Istituto Europeo di Oncologia (IEO)
Milan, 20141, Italy
Centro Oncologico Modenese
Modena, 41122, Italy
S.C. Oncologia/Az. Osp.Ra. S Maria Terni
Terni, 05100, Italy
Szpitale Pomorskie Oddział Onkologii i Radioterapii Powstania
Gdynia, Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Oddzial Onkologii z Pododdzialem Chemoioterapii
Olsztyn, 10-357, Poland
Mrukmed
Rzeszów, 35-021, Poland
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej Centrum Onkologii-Instytut
Warsaw, 02-781, Poland
Wilmed
Warsaw, Poland
Onko-Dent G.L.Slomian
Żory, Poland
State Oncology Clinical Dispansery
Saint Petersburg, 198255, Russia
Federal State Budgetary Institution Research Institute of Oncology named after N.N. Petrov of the Ministry of Health of the Russian Federation
Saint Petersburg, Russia
John Hopkins Singapore International Medical Centre
Singapore, Singapore
National Cancer Centre Singapore
Singapore, Singapore
National University Hospital
Singapore, Singapore
Dong-A University Hospital
Busan, South Korea
Kyungpook National University Hospital
Daegu, South Korea
National Cancer Center
Goyang, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
St. Vincents Hospital
Suwon, South Korea
Onkologikoa
San Sebastián, Gipuzkoa, Spain
Althaia Hospital Sant Joan de Deu
Barcelona, Manresa, 08243, Spain
Hospital Teresa Herrera Materno-Infantil (CHUAC)
A Coruña, 15006, Spain
Centro Oncológico de Galicia
A Coruña, 15009, Spain
Hospital Quironsalud Barcelona
Barcelona, 08023, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Institut Catala d'Oncologia
Barcelona, 08908, Spain
HU San Pedro de Alcantara
Cáceres, 10003, Spain
Hospital Universitario Ramon y Cajal Servicio de Oncologia
Madrid, 28034, Spain
IOB_Hospital Ruber Internacional
Madrid, 28034, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Miguel Servet Paseo Isabel la Catolica 1-3 Edificio de Maternidad
Zaragoza, 50009, Spain
Changhua Christian Hospital
Taichung, Taiwan
Chi Mei Medical Center
Tainan, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital Linkou Branch
Taoyuan District, Taiwan
Chulabhorn Hospital
Bangkok, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Buddhachinaraj Hospital
Phitsanulok, Thailand
Dnipropetrovsk City Multifield Clinical Hospital #4
Dnipro, 49102, Ukraine
Communal Non-Profit Enterprise "Regional Center of Oncology"
Kharkiv, 61070, Ukraine
Kryviy Rih Onkology Dispensary
Kryvyi Rih, 50048, Ukraine
National Cancer Institute
Kyiv, 03022, Ukraine
Municipal Institution of Lviv Regional Council - Lviv Oncology Regional Treatment Diagnostic Center
Lviv, 79031, Ukraine
Central City Clinical Hospital, City Oncology Center
Uzhhorod, 88000, Ukraine
Podilskiy Regional Center of Oncology
Vinnytsia, 21029, Ukraine
Communal Institution "Zaporizhzhia Regional Clinical Oncological Dispensary"
Zaporizhzhia, 69040, Ukraine
Royal Cornwall Hospital Oncology Trials, Sunrise Centre
Truro, Cornwall, TR1 3LJ, United Kingdom
Hertford County Hospital
Hertford, SG14 1LP, United Kingdom
Cancer Centre, Guy's Hospital
London, SE1 9RT, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joseph O'Connell, MD
Odonate Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2017
First Posted
October 31, 2017
Study Start
December 21, 2017
Primary Completion
August 24, 2020
Study Completion
June 28, 2021
Last Updated
July 30, 2021
Record last verified: 2021-07