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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03326674




Registration number
NCT03326674
Ethics application status
Date submitted
13/10/2017
Date registered
31/10/2017

Titles & IDs
Public title
Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
Scientific 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
Secondary ID [1] 0 0
ODO-TE-B301
Universal Trial Number (UTN)
Trial acronym
CONTESSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tesetaxel and Capecitabine
Treatment: Drugs - Capecitabine

Experimental: Arm A: Tesetaxel (oral) and capecitabine (oral) - Tesetaxel (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

Active comparator: Arm B: Capecitabine (oral) - Capecitabine (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


Treatment: Drugs: Tesetaxel and Capecitabine
Tesetaxel plus reduced dose of Capecitabine

Treatment: Drugs: Capecitabine
Capecitabine alone at approved dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PFS as assessed by the IRC
Timepoint [1] 0 0
Approximately 2.5-3.0 years
Secondary outcome [1] 0 0
OS
Timepoint [1] 0 0
Approximately 5.0-5.5 years
Secondary outcome [2] 0 0
ORR as assessed by the IRC
Timepoint [2] 0 0
Approximately 2.5-3.0 years
Secondary outcome [3] 0 0
DCR as assessed by the IRC
Timepoint [3] 0 0
Approximately 2.5-3.0 years
Secondary outcome [4] 0 0
Central nervous system (CNS) ORR as assessed by the CNS IRC in patients with CNS metastases at baseline
Timepoint [4] 0 0
Approximately 2.5-3.0 years
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Approximately 2.5-3.0 years
Secondary outcome [6] 0 0
CNS OS in patients with CNS metastases at baseline or a history of CNS metastases
Timepoint [6] 0 0
Approximately 2.5-3.0 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/06/2021
Sample size
Target
Accrual to date
Final
685
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [3] 0 0
Mater Cancer Care Centre - South Brisbane
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [6] 0 0
Peninsula and South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [7] 0 0
Breast Cancer Research Centre - Nedlands
Recruitment hospital [8] 0 0
St. John of God Subiaco Hospital - Perth
Recruitment hospital [9] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2076 - Wahroonga
Recruitment postcode(s) [3] 0 0
- South Brisbane
Recruitment postcode(s) [4] 0 0
- Woolloongabba
Recruitment postcode(s) [5] 0 0
- Clayton
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
- Nedlands
Recruitment postcode(s) [8] 0 0
- Perth
Recruitment postcode(s) [9] 0 0
- Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
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Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
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Colorado
Country [5] 0 0
United States of America
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Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Montana
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Nebraska
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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Austria
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Salzburg
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Austria
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Schwaz
Country [33] 0 0
Austria
State/province [33] 0 0
Vienna
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Austria
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Wien
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Belgium
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Antwerp
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Belgium
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Brussels
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Belgium
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Edegem
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Belgium
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Leuven
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Belgium
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Liège
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Canada
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New Brunswick
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Canada
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Nova Scotia
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Ontario
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Quebec
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Canada
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Québec
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Czechia
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Horovice
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Czechia
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Olomouc
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Czechia
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Praha
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France
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Besançon
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France
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Caen
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France
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Pierre-Benite
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Rennes
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Saint-Cloud
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France
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Strasbourg
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France
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Tours
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Germany
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Berlin
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Germany
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NRW
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Germany
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Rhineland-Palatinate
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Lueneburg
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Germany
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München
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Hungary
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Budapest
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Hungary
State/province [63] 0 0
Nyíregyháza
Country [64] 0 0
Hungary
State/province [64] 0 0
Pécs
Country [65] 0 0
Italy
State/province [65] 0 0
Milano
Country [66] 0 0
Italy
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Modena
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Italy
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Terni
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Goyang
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Poland
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Gdynia
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Poland
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Olsztyn
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Poland
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Rzeszów
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Warsaw
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Warszawa
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Poland
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Zory
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Russian Federation
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Saint Petersburg
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Singapore
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Singapore
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Spain
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Gipuzkoa
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Spain
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Manresa
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Spain
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A Coruña
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Spain
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Barcelona
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Spain
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Cáceres
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Spain
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La Coruña
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Zaragoza
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Taiwan
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Taichung
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Taiwan
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Tainan City
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Phitsanulok
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Ukraine
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Dnipro
Country [100] 0 0
Ukraine
State/province [100] 0 0
Kharkiv
Country [101] 0 0
Ukraine
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Kryvyi Rih
Country [102] 0 0
Ukraine
State/province [102] 0 0
Kyiv
Country [103] 0 0
Ukraine
State/province [103] 0 0
Lviv
Country [104] 0 0
Ukraine
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Vinnytsia
Country [105] 0 0
Ukraine
State/province [105] 0 0
Zaporizhzhia
Country [106] 0 0
Ukraine
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Úzhgorod
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Cornwall
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United Kingdom
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Hertford
Country [109] 0 0
United Kingdom
State/province [109] 0 0
London
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Odonate Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joseph O'Connell, MD
Address 0 0
Odonate Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Currently under evaluation by the organization


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03326674