Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC

Breast Cancer Clinical Trial

— CONTESSA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03326674
• Other study ID #: ODO-TE-B301
• Status: Terminated
• Phase: Phase 3
• Start date: December 21, 2017
• Est. completion date: June 28, 2021

Study information

• Verified date: July 2021
• Source: Odonate Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with HER2 negative, HR positive locally advanced or metastatic breast cancer (LA/MBC) previously treated with a taxane in the neoadjuvant or adjuvant setting. 685 patients were enrolled, including 674 who received treatment.

Patients randomly assigned to Arm A (tesetaxel plus a reduced dose of capecitabine) are administered:

• Tesetaxel (27 mg/m2) orally once every 21 days on Day 1 of each 21-day cycle; and

• Capecitabine (825 mg/m2) orally 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.

Patients randomly assigned to Arm B (approved dose of capecitabine alone) are administered:

• Capecitabine (1,250 mg/m2) orally 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

Dose modifications for tesetaxel and/or capecitabine are described in the study protocol.

Patients are treated until documentation of progressive disease (PD), evidence of unacceptable toxicity or other decision to discontinue treatment. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. The primary efficacy endpoint is PFS as assessed by the IRC. The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 685
• Est. completion date: June 28, 2021
• Est. primary completion date: August 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female or male patients at least 18 years of age

2. Histologically or cytologically confirmed breast cancer

3. 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

4. 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

5. 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

6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

7. Prior therapy (at least one completed dose) with a taxane-containing regimen in the neoadjuvant or adjuvant setting

8. Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated by local regulation or Investigator judgment.

9. Prior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive LA/MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.

10. Documented disease recurrence or disease progression of: (a) locally advanced disease that is not considered curable by surgery and/or radiation; or (b) metastatic disease.

11. Adequate hematologic, hepatic and renal function, as evidenced by:

• Absolute neutrophil count (ANC) = 1,500/µL without colony-stimulating factor support

• Platelet count = 100,000/µL

• Hemoglobin = 10 g/dL without need for hematopoietic growth factor or transfusion support

• Total bilirubin < 1.5 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome

• Alanine aminotransferase (ALT) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN

• Aspartate aminotransferase (AST) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN

• Alkaline phosphatase < 2.5 × ULN unless hepatic metastases are present, then < 5 × ULN

• Calculated creatinine clearance = 50 mL/min (by Cockcroft-Gault formula or local standard)

• Serum albumin = 3.0 g/dL

• Prothrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3, and partial thromboplastin time (PTT) < 1.5 × ULN, unless the patient is on a therapeutic anticoagulant

12. Complete recovery to baseline or Grade 1 per National Cancer Institute (NCI) CTCAE version 5.0 from adverse effects of prior surgery, radiotherapy, endocrine therapy and other therapy, as applicable, with the exception of Grade 2 alopecia from prior chemotherapy

13. Ability to swallow an oral solid-dosage form of medication

14. A negative serum pregnancy test within 7 days prior to the first dose of Study treatment in women of childbearing potential (ie, all women except those who are post menopause for = 1 year or who have a history of hysterectomy or surgical sterilization)

15. Women of childbearing potential must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 70 days after the last dose of study treatment

• Acceptable methods include: copper intrauterine devices or double barrier methods, including male/female condoms with spermicide and use of contraceptive sponge, cervical cap, or diaphragm

16. Male patients must use an effective, non-hormonal form of contraception from screening throughout the treatment phase and until 130 days after last dose of study treatment

• Acceptable methods include male/female condoms with spermicide, or vasectomy with medical confirmation of surgical success

17. Written informed consent and authorization to use and disclose health information

18. Ability to comprehend and comply with the requirements of the study

Exclusion Criteria:

1. Two or more prior chemotherapy regimens for advanced disease

2. Prior treatment with a taxane in the metastatic setting

3. Prior treatment with capecitabine at any dose

4. Current evidence of leptomeningeal disease

5. 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

6. 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.

7. Active hepatitis B or active hepatitis C infection

8. 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

9. Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0

10. History of hypersensitivity to taxanes; hypersensitivity to the solvent does not preclude patient participation in this study

11. 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

12. Major surgery = 28 days prior to the date of randomization; patient must have complete recovery from surgery

13. 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)

14. History of hypersensitivity or unexpected reactions to capecitabine, other fluoropyrimidine agents or any of their ingredients

15. 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.

16. Pregnant or breastfeeding

17. If, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the study

18. Treatment with brivudine, sorivudine or its chemically-related analogs = 28 days prior to the date of randomization

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tesetaxel and Capecitabine
Tesetaxel plus reduced dose of Capecitabine
• Capecitabine
Capecitabine alone at approved dose

Locations

Country	Name	City	State
Australia	Border Medical Oncology	Albury	New South Wales
Australia	Flinders Medical Centre	Bedford Park
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Peninsula and South Eastern Haematology and Oncology Group	Frankston	Victoria
Australia	Breast Cancer Research Centre	Nedlands	Western Australia
Australia	St. John of God Subiaco Hospital	Perth	Western Australia
Australia	Mater Cancer Care Centre	South Brisbane	Queensland
Australia	Sydney Adventist Hospital	Wahroonga	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	Universitätsklinik Onkologie Landeskkrankenhaus	Salzburg
Austria	Facharzt für Frauenheilkunde und Geburtshilfe Spezialist für Brustchirurgie und Brustkrebs	Schwaz
Austria	AKH-Frauenheilkunde	Vienna
Austria	Ludwig Boltzmann Institut fur Klinische Onkologie und Photodynamische Therapie	Wien
Belgium	AZ Klina AUGUSTIJNSLEI	Antwerp
Belgium	Institut Jules Bordet	Brussels
Belgium	UZA	Edegem
Belgium	UZ Leuven	Leuven
Belgium	CHC-Sant Joseph Oncology-Hematology	Liège
Canada	QEII Health Sciences Centre - Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	Center Hospitalier de Montreal CHUM McPeak Sirois	Montréal	Quebec
Canada	CIUSSS de Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital	Montréal	Quebec
Canada	Hopital Maisonneuve-Rosemont	Montréal	Quebec
Canada	McGill University Health Center	Montréal	Quebec
Canada	CHU de Quebec-University Laval	Québec
Canada	Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre	Sherbrooke	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Czechia	NH Hospital a.s. Nemocnice Horovice Onkologie	Horovice
Czechia	Onkologicka Klinika FN Olomouc	Olomouc
Czechia	Onkologicka Klinika (Fakultni Nemocnice v Motole)	Praha
Czechia	Onkologicka Klinika (Vseobecna Fakultni Nemocnici v Praze )	Praha
France	CHRU J. Minjoz Service Oncologie	Besançon
France	Centre François Baclesse Service the Recherche Clinique	Caen
France	Hospices Civils de Lyon Sud Oncologie Medicale	Pierre-Benite
France	Centre Eugène Marquis	Rennes
France	Institut Curie - Hopital Rene Huguenin	Saint-Cloud
France	Clinique Sainte Anne - Strasbourg Oncologie Liberale	Strasbourg
France	Centre Hospitalier Regional et Universitaire de Tours CHRU	Tours
Germany	Charité Universitätsmedizin Berlin-Campus Benjamin Franklin Klinik für Hämatologie, Onkologie und Tumorimmunologie	Berlin
Germany	Helios Klinikum Berlin-Buch	Berlin
Germany	Arzt der Studienzentrale Universitätsklinikum Erlangen	Erlangen	Berlin
Germany	Mammazentrum HH am Krankenhaus Jerusalem	Hamburg
Germany	UKSH, Campus Kiel Klinik für Gynäkologie und Geburtshilfe	Kiel
Germany	InVO - Institut für Versorgungsforschung	Koblenz	Rhineland-Palatinate
Germany	St. Elisabeth-Krankenhaus GmbH	Köln	NRW
Germany	Staedtisches Klinikum Lueneburg gGmbH Brustzentrum und gynaekologisches Krebszentrum der Frauenklinik	Lueneburg
Germany	LMU Klinikum der Universität München Breast Cancer	München
Germany	Technische Universität München Klinikum rechts der Isar Klinik und Poliklinik für Frauenheilkunde	München
Germany	St. Elisabethgruppe GmbH Marien Hospital Witten Brustzentrum	Witten	Rhineland-Palatinate
Hungary	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
Italy	Istituto Europeo di Oncologia (IEO)	Milano
Italy	Ospedale San Raffaele - Medical Oncology Dept.	Milano
Italy	Centro Oncologico Modenese	Modena
Italy	S.C. Oncologia/Az. Osp.Ra. S Maria Terni	Terni
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	National Cancer Center	Goyang
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	St. Vincents Hospital	Suwon
Poland	Szpitale Pomorskie Oddzial Onkologii i Radioterapii Powstania	Gdynia
Poland	Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Oddzial Onkologii z Pododdzialem Chemoioterapii	Olsztyn
Poland	Mrukmed	Rzeszów
Poland	Wilmed	Warsaw
Poland	Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej Centrum Onkologii-Instytut	Warszawa
Poland	Onko-Dent G.L.Slomian	Zory
Russian Federation	Federal State Budgetary Institution Research Institute of Oncology named after N.N. Petrov of the Ministry of Health of the Russian Federation	Saint Petersburg
Russian Federation	State Oncology Clinical Dispansery	Saint Petersburg
Singapore	John Hopkins Singapore International Medical Centre	Singapore
Singapore	National Cancer Centre Singapore	Singapore
Singapore	National University Hospital	Singapore
Spain	Hospital Teresa Herrera Materno-Infantil (CHUAC)	A Coruña
Spain	Althaia Hospital Sant Joan de Deu	Barcelona	Manresa
Spain	Hospital Quironsalud Barcelona	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Institut Catala d'Oncologia	Barcelona
Spain	HU San Pedro de Alcantara	Cáceres
Spain	Centro Oncológico de Galicia	La Coruña
Spain	Fundacion Jimenez Diaz	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Ramon y Cajal Servicio de Oncologia	Madrid
Spain	IOB_Hospital Ruber Internacional	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Onkologikoa	San Sebastián	Gipuzkoa
Spain	Hospital Universitario Miguel Servet Paseo Isabel la Catolica 1-3 Edificio de Maternidad	Zaragoza
Taiwan	Changhua Christian Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chi Mei Medical Center	Tainan City
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital Linkou Branch	Taoyuan
Thailand	Chulabhorn Hospital	Bangkok
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Buddhachinaraj Hospital	Phitsanulok
Ukraine	Dnipropetrovsk City Multifield Clinical Hospital #4	Dnipro
Ukraine	Communal Non-Profit Enterprise "Regional Center of Oncology"	Kharkiv
Ukraine	Kryviy Rih Onkology Dispensary	Kryvyi Rih
Ukraine	National Cancer Institute	Kyiv
Ukraine	Municipal Institution of Lviv Regional Council - Lviv Oncology Regional Treatment Diagnostic Center	Lviv
Ukraine	Central City Clinical Hospital, City Oncology Center	Úzhgorod
Ukraine	Podilskiy Regional Center of Oncology	Vinnytsia
Ukraine	Communal Institution "Zaporizhzhia Regional Clinical Oncological Dispensary"	Zaporizhzhia
United Kingdom	Hertford County Hospital	Hertford
United Kingdom	Cancer Centre, Guy's Hospital	London
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Royal Cornwall Hospital Oncology Trials, Sunrise Centre	Truro	Cornwall
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	New Mexico Cancer Care Alliance - Southwest Gynecology Oncology	Albuquerque	New Mexico
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Pacific Cancer Medical Center	Anaheim	California
United States	University Cancer and Blood Center	Athens	Georgia
United States	CBCC Global Research, Inc.	Bakersfield	California
United States	GBMC Cancer Center	Baltimore	Maryland
United States	University of Maryland - Greenebaum Comprehensive Cancer Center	Baltimore	Maryland
United States	Texas Oncology - Bedford	Bedford	Texas
United States	Overlake Medical Center	Bellevue	Washington
United States	SMHC Cancer Care and Blood Disorders	Biddeford	Maine
United States	St. Vincent Frontier Cancer Center	Billings	Montana
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	New Jersey Hematology Oncology Associates	Brick	New Jersey
United States	Ironwood Cancer and Research Centers	Chandler	Arizona
United States	University of North Carolina Lineberger Cancer Center	Chapel Hill	North Carolina
United States	Chevy Chase Health Care Center/ RCCA	Chevy Chase	Maryland
United States	University of Chicago Medical Center - Duchossois Center for Advanced Medicine (DCAM)	Chicago	Illinois
United States	Ohio State University Comprehensive Cancer Center, Stephanie Spielman Comprehensive Breast Center	Columbus	Ohio
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology - Dallas Presbyterian Hospital	Dallas	Texas
United States	Texas Oncology - Medical City Dallas	Dallas	Texas
United States	Western Connecticut Health Network	Danbury	Connecticut
United States	Henry Ford Hospital	Detroit	Michigan
United States	Regional Cancer Care Associates	East Brunswick	New Jersey
United States	New York Cancer and Blood Specialists	East Setauket	New York
United States	Hematology Oncology Associates of Central New York, P.C.	East Syracuse	New York
United States	Sarah Cannon Research Institute - Florida Cancer Specialists	Fort Myers	Florida
United States	Compassionate Care Research Group	Fountain Valley	California
United States	James M. Stockman Cancer Institute	Frederick	Maryland
United States	California Cancer Associates for Research and Excellence	Fresno	California
United States	St. Joseph Heritage Healthcare	Fullerton	California
United States	West Cancer Center	Germantown	Tennessee
United States	Cancer Treatment Centers of America - Western Regional Medical Center	Goodyear	Arizona
United States	Cancer and Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	Hartford Healthcare	Hartford	Connecticut
United States	Forrest General Cancer Center/Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Memorial Healthcare System	Hollywood	Florida
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	Oncology Consultants	Houston	Texas
United States	Texas Oncology - Memorial City	Houston	Texas
United States	Westside Surgical Hospital and Breast Center	Houston	Texas
United States	American Health Network	Indianapolis	Indiana
United States	Jackson Oncology Associates	Jackson	Mississippi
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Broome Oncology, LLC	Johnson City	New York
United States	Mercy Cancer Center	Joplin	Missouri
United States	HCA Midwest Health	Kansas City	Missouri
United States	Kadlec Regional Medical Center	Kennewick	Washington
United States	Rocky Mountain Cancer Center	Lakewood	Colorado
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Carti Cancer Center	Little Rock	Arkansas
United States	UCLA Medical Center	Los Angeles	California
United States	Miami Cancer Institute	Miami	Florida
United States	Bon Secours St. Francis	Midlothian	Virginia
United States	Virginia Piper Cancer Institute, Allina Health	Minneapolis	Minnesota
United States	Sarah Cannon Research Institute at Tennessee Oncology	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Cancer Treatment Centers of America	Newnan	Georgia
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Florida Cancer Affiliates - Ocala	Ocala	Florida
United States	Mercy Clinic Oncology and Hematology	Oklahoma City	Oklahoma
United States	Orlando Health	Orlando	Florida
United States	Oncology Hematology West, P.C. dba Nebraska Cancer Specialists	Papillion	Nebraska
United States	Cancer Treatment Centers of America - Philadelphia	Philadelphia	Pennsylvania
United States	Magee-Women's Hospital of UPMC	Pittsburgh	Pennsylvania
United States	University of Miami Sylvester Comprehensive Cancer Center / Sylvester at Plantation	Plantation	Florida
United States	Cancer Care - Torrance Memorial Physician Network	Redondo Beach	California
United States	Virginia Cancer Institute	Richmond	Virginia
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Maryland Oncology Hematology, P.A.	Rockville	Maryland
United States	Mercy Hospital St. Louis, David C. Pratt Cancer Center	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Florida Cancer Specialists and Research Institute	Saint Petersburg	Florida
United States	Sharp Memorial Hospital	San Diego	California
United States	University of California San Francisco - Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	San Luis Obispo Oncology & Hematology Health Center	San Luis Obispo	California
United States	California Cancer Associates for Research and Excellence	San Marcos	California
United States	Cancer Research Collaboration and Breast Link	Santa Ana	California
United States	Swedish Cancer Center	Seattle	Washington
United States	Orchard Healthcare Research	Skokie	Illinois
United States	Regional Cancer Care Associates, LLC-Sparta	Sparta	New Jersey
United States	Stanford Cancer Center / Cancer Clinical Trials	Stanford	California
United States	Northwest Medical Specialties	Tacoma	Washington
United States	Florida Cancer Specialists and Research Institute - Panhandle Region	Tallahassee	Florida
United States	Arizona Oncology Associates, P.C. - HOPE	Tucson	Arizona
United States	Oklahoma Cancer Specialists and Research Institute, LLC	Tulsa	Oklahoma
United States	Hope Cancer Center of East Texas	Tyler	Texas
United States	Florida Cancer Specialists and Research Institute	West Palm Beach	Florida
United States	Innovative Clinical Research Institute	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Odonate Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Poland,  Russian Federation,  Singapore,  Spain,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	EORTC QLQ-C30 Functional Scales and Symptom Scales/Items		Approximately 2.5-3.0 years
Other	Adverse events, including deaths and other serious adverse events		Approximately 5.0-5.5 years
Other	Incidence of clinical laboratory abnormalities (e.g., CBC, serum chemistry and coagulation testing)		Approximately 5.0-5.5 years
Other	Peak plasma concentration (Cmax) of tesetaxel		Approximately 2.5-3.0 years
Other	Area under the plasma concentration versus time curve (AUC) of tesetaxel		Approximately 2.5-3.0 years
Primary	PFS as assessed by the IRC		Approximately 2.5-3.0 years
Secondary	OS		Approximately 5.0-5.5 years
Secondary	ORR as assessed by the IRC		Approximately 2.5-3.0 years
Secondary	DCR as assessed by the IRC		Approximately 2.5-3.0 years
Secondary	Central nervous system (CNS) ORR as assessed by the CNS IRC in patients with CNS metastases at baseline		Approximately 2.5-3.0 years
Secondary	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
Secondary	CNS OS in patients with CNS metastases at baseline or a history of CNS metastases		Approximately 2.5-3.0 years