Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01193244
Registration number
NCT01193244
Ethics application status
Date submitted
31/08/2010
Date registered
1/09/2010
Date last updated
17/05/2017
Titles & IDs
Public title
Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
Query!
Scientific title
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
Query!
Secondary ID [1]
0
0
2010-018661-35
Query!
Secondary ID [2]
0
0
C21004
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Orteronel
Treatment: Drugs - Placebo
Treatment: Drugs - Prednisone
Experimental: Orteronel + prednisone -
Placebo comparator: Placebo + prednisone -
Treatment: Drugs: Orteronel
Orteronel will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of \<50 ng/dL.
Treatment: Drugs: Placebo
Placebo will be administered orally twice a day continuously throughout the study. Additionally, all patients will receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and a testosterone concentration of \<50 ng/dL.
Treatment: Drugs: Prednisone
Prednisone will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of \<50 ng/dL.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Radiographic Progression-free Survival (rPFS)
Query!
Assessment method [1]
0
0
rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for soft tissue disease and Prostate Cancer Working Group (PCWG2) guidelines for bone disease. Participants who did not reach the endpoint were censored at their last assessment.
Query!
Timepoint [1]
0
0
Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years)
Query!
Primary outcome [2]
0
0
Overall Survival
Query!
Assessment method [2]
0
0
Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.
Query!
Timepoint [2]
0
0
Baseline until death (up to 4.7 years)
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12
Query!
Assessment method [1]
0
0
The PSA50 is defined as a decline of at least 50 percent (%) from baseline.
Query!
Timepoint [1]
0
0
Week 12
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12
Query!
Assessment method [2]
0
0
A favorable CTC count was defined as less than \<5 counts per 7.5 milliliter (mL) in whole blood. An unfavorable CTC count was defined as greater than or equal to (\>=) 5 counts/7.5 mL in whole blood.
Query!
Timepoint [2]
0
0
Week 12
Query!
Secondary outcome [3]
0
0
Time to Pain Progression
Query!
Assessment method [3]
0
0
Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was \>=4 with a \>=2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was \>=4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was \<=3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 100 with lower scores being indicative of less pain or pain interference.
Query!
Timepoint [3]
0
0
Baseline until End of treatment (EOT) (approximately up to 4.7 years)
Query!
Secondary outcome [4]
0
0
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)
Query!
Secondary outcome [5]
0
0
Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3
Query!
Assessment method [5]
0
0
Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE.
Query!
Timepoint [5]
0
0
Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)
Query!
Secondary outcome [6]
0
0
Number of Participants With TEAEs Related to Vital Signs
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)
Query!
Secondary outcome [7]
0
0
Number of Participants With TEAEs Related to Weight
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)
Query!
Secondary outcome [8]
0
0
Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status
Query!
Assessment method [8]
0
0
ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50 percent of waking hours \[hrs\]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50 percent of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period.
Query!
Timepoint [8]
0
0
Baseline until EOT (approximately up to 4.7 years)
Query!
Secondary outcome [9]
0
0
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Baseline up to EOT (Cycle 61 Day 58)
Query!
Secondary outcome [10]
0
0
Worst Change From Baseline Over Time in Cardiac Ejection Fraction
Query!
Assessment method [10]
0
0
Worst change was defined as the worst overall change that occurred in cardiac ejection fraction at any measured time point.
Query!
Timepoint [10]
0
0
Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)
Query!
Secondary outcome [11]
0
0
Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)
Query!
Secondary outcome [12]
0
0
Percentage of Participants With Skeletal Related Events (SRE)
Query!
Assessment method [12]
0
0
Skeletal related (SRE) event is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence.
Query!
Timepoint [12]
0
0
Baseline up to EOT (approximately up to 4.7 years)
Query!
Secondary outcome [13]
0
0
Time to SRE
Query!
Assessment method [13]
0
0
Time to SRE is defined as the time from randomization to SRE, or death due to any cause, whichever comes first. SRE is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence.
Query!
Timepoint [13]
0
0
Baseline up to EOT (Cycle 61 Day 58)
Query!
Secondary outcome [14]
0
0
Percentage of Participants Achieving PSA50 Response at Any Time During the Study
Query!
Assessment method [14]
0
0
The PSA50 is defined as a decline of PSA by 50 percent from baseline.
Query!
Timepoint [14]
0
0
Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37
Query!
Secondary outcome [15]
0
0
Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12
Query!
Assessment method [15]
0
0
The PSA90 is defined as a decline of PSA by 90 percent from baseline.
Query!
Timepoint [15]
0
0
Week 12
Query!
Secondary outcome [16]
0
0
Percentage of Participants Achieving PSA90 Response at Any Time During the Study
Query!
Assessment method [16]
0
0
The PSA90 is defined as a decline of PSA by 90 percent from baseline.
Query!
Timepoint [16]
0
0
Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37
Query!
Secondary outcome [17]
0
0
Time to PSA Progression
Query!
Assessment method [17]
0
0
Time to PSA progression was defined as time from randomization to a PSA increase of 25 percent and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, compared to baseline PSA.
Query!
Timepoint [17]
0
0
Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.7 years)
Query!
Secondary outcome [18]
0
0
Time to Docetaxel Chemotherapy
Query!
Assessment method [18]
0
0
Time to docetaxel based chemotherapy is defined as the time from randomization to the start of docetaxel based chemotherapy for prostate cancer, regardless of whether the participant received concurrent orteronel or not. Deaths due to disease progression prior to Docetaxel based chemotherapy were considered as events.
Query!
Timepoint [18]
0
0
Baseline until start of docetaxel chemotherapy (up to 4.7 years)
Query!
Secondary outcome [19]
0
0
Time to Subsequent Antineoplastic Therapy
Query!
Assessment method [19]
0
0
Time to subsequent antineoplastic therapy is defined as the time from randomization to the start of any alternate antineoplastic therapy for prostate cancer. Deaths due to disease progression prior to antineoplastic therapy for prostate cancer are considered as events. Otherwise, time to next therapy is censored at the date of death or the last date the participant was known to be alive or the data cutoff date, whichever is earlier.
Query!
Timepoint [19]
0
0
Baseline until start of subsequent antineoplastic therapy (up to 4.7 years)
Query!
Secondary outcome [20]
0
0
Percentage of Participants With Objective Response
Query!
Assessment method [20]
0
0
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. A CR was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter or short axis of lymph nodes.
Query!
Timepoint [20]
0
0
Baseline until disease progression or death, whichever occurred first (approximately up to 4.7 years)
Query!
Secondary outcome [21]
0
0
Time to Deterioration in Global Health Status
Query!
Assessment method [21]
0
0
Global health status deterioration is defined as a drop greater than 16 points from the baseline assessment, confirmed at least 3 weeks later, on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module 30 (EORTC QLQ-C30) index after the score has been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30 consists of 30 questions, where question 1 to 28 can be answered with 1: Not at all, 2: A little, 3: Quite a bit, 4: Very much and question 29 to 30 with 1: Very poor to 7: Excellent. For subscales a high score from 0-100 indicates: high global quality of life, high level of functioning (physical, role, emotional, cognitive, social) or a high level of symptoms (fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties).
Query!
Timepoint [21]
0
0
Baseline until EOT (approximately up to 4.7 years)
Query!
Eligibility
Key inclusion criteria
Each patient must meet all of the following inclusion criteria:
* Voluntary written consent
* Male patients 18 years or older
* Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
* Radiograph-documented metastatic disease
* Progressive disease
* Prior surgical castration or concurrent use of an agent for medical castration
* Either absence of pain or pain not requiring use of any opioid or narcotic analgesia in the 2 weeks prior to study entry
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Even if surgically sterilized, patients must practice effective barrier contraception during the entire study treatment and for 4 months after the last dose of study drug, OR abstain from heterosexual intercourse
* Meet screening laboratory values as specified in protocol
* Stable medical condition
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
* Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue
* Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone
* Received antiandrogen therapy within 6 weeks for bicalutamide and 4 weeks for all others prior to first dose of study drug
* Continuous daily use of oral prednisone or oral dexamethasone for more than 14 days within 3 months prior to study
* Received prior chemotherapy for prostate cancer with exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years prior to screening
* Exposure to radioisotope therapy within 4 weeks of receiving first dose of study drug; exposure to external beam radiation within 2 weeks of start of screening until receiving the first dose of study drug
* Documented central nervous system metastases
* Treatment with any investigational compound within 30 days prior to first dose of study drug
* Current spinal cord compression, bilateral hydronephrosis or current bladder neck outlet obstruction
* Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
* Uncontrolled cardiovascular condition as specified in study protocol
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
* Unwilling or unable to comply with protocol
* Uncontrolled nausea, vomiting or diarrhea
* Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
7/04/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1560
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Garran
Query!
Recruitment hospital [2]
0
0
- Hobart
Query!
Recruitment hospital [3]
0
0
- Kurralta Park
Query!
Recruitment hospital [4]
0
0
- Nedlands
Query!
Recruitment hospital [5]
0
0
- Perth
Query!
Recruitment hospital [6]
0
0
- Redcliffe
Query!
Recruitment hospital [7]
0
0
- Wodonga
Query!
Recruitment postcode(s) [1]
0
0
- Garran
Query!
Recruitment postcode(s) [2]
0
0
- Hobart
Query!
Recruitment postcode(s) [3]
0
0
- Kurralta Park
Query!
Recruitment postcode(s) [4]
0
0
- Nedlands
Query!
Recruitment postcode(s) [5]
0
0
- Perth
Query!
Recruitment postcode(s) [6]
0
0
- Redcliffe
Query!
Recruitment postcode(s) [7]
0
0
- Wodonga
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alaska
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Mississippi
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nebraska
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nevada
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New York
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Ohio
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oregon
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Pennsylvania
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
South Carolina
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Tennessee
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Texas
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Utah
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Virginia
Query!
Country [28]
0
0
Austria
Query!
State/province [28]
0
0
Graz
Query!
Country [29]
0
0
Austria
Query!
State/province [29]
0
0
Linz
Query!
Country [30]
0
0
Austria
Query!
State/province [30]
0
0
Wien
Query!
Country [31]
0
0
Belarus
Query!
State/province [31]
0
0
Minsk
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Edegem
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Hasselt
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Kortrijk
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Leuven
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Namur
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Bairro Nazare - Salvador
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Barretos/sp
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Belo Horizonte
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
Campinas
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Caxias Do Sul
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Curitiba
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Fortaleza/ce
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Ijui
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Joinville
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Lajeado - Rs
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Piracicaba - Sp
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
Porto Alegre- Rs
Query!
Country [49]
0
0
Brazil
Query!
State/province [49]
0
0
Porto Alegre/rs
Query!
Country [50]
0
0
Brazil
Query!
State/province [50]
0
0
Ribeirao Preto - Sp
Query!
Country [51]
0
0
Brazil
Query!
State/province [51]
0
0
Rio de Janeiro Rj
Query!
Country [52]
0
0
Brazil
Query!
State/province [52]
0
0
Rio de Janeiro
Query!
Country [53]
0
0
Brazil
Query!
State/province [53]
0
0
Santo Andre
Query!
Country [54]
0
0
Brazil
Query!
State/province [54]
0
0
Sao Jose Do Rio Preto
Query!
Country [55]
0
0
Brazil
Query!
State/province [55]
0
0
Sao Jose Dos Campos
Query!
Country [56]
0
0
Brazil
Query!
State/province [56]
0
0
Sao Paulo
Query!
Country [57]
0
0
Brazil
Query!
State/province [57]
0
0
Sorocaba - Sp
Query!
Country [58]
0
0
Bulgaria
Query!
State/province [58]
0
0
Plovdiv
Query!
Country [59]
0
0
Bulgaria
Query!
State/province [59]
0
0
Sofia
Query!
Country [60]
0
0
Bulgaria
Query!
State/province [60]
0
0
Varna
Query!
Country [61]
0
0
Canada
Query!
State/province [61]
0
0
British Columbia
Query!
Country [62]
0
0
Canada
Query!
State/province [62]
0
0
Ontario
Query!
Country [63]
0
0
Canada
Query!
State/province [63]
0
0
Quebec
Query!
Country [64]
0
0
Chile
Query!
State/province [64]
0
0
Las Condes
Query!
Country [65]
0
0
Chile
Query!
State/province [65]
0
0
Santiago
Query!
Country [66]
0
0
Chile
Query!
State/province [66]
0
0
Temuco
Query!
Country [67]
0
0
Chile
Query!
State/province [67]
0
0
Valparaiso
Query!
Country [68]
0
0
Colombia
Query!
State/province [68]
0
0
Cali
Query!
Country [69]
0
0
Czech Republic
Query!
State/province [69]
0
0
Hradec Kralove
Query!
Country [70]
0
0
Czech Republic
Query!
State/province [70]
0
0
Praha 4
Query!
Country [71]
0
0
Czech Republic
Query!
State/province [71]
0
0
Praha 5
Query!
Country [72]
0
0
Finland
Query!
State/province [72]
0
0
Joensuu
Query!
Country [73]
0
0
Finland
Query!
State/province [73]
0
0
Oulu
Query!
Country [74]
0
0
Finland
Query!
State/province [74]
0
0
Seinajoki
Query!
Country [75]
0
0
Finland
Query!
State/province [75]
0
0
Tampere
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Angers
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Bordeaux
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Caen
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Creteil
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
La Roche Sur Yon
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Lyon
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Marseille
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Nancy
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Nantes
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Paris Cedex 13
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Paris Cedex 14
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Paris
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Poitiers
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Saint-etienne
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Villejuif
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Braunschweig
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Dresden
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Hamburg
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Hannover
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Kassel
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Kempen
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Nurtingen
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Tubingen
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Wuppertal
Query!
Country [100]
0
0
Greece
Query!
State/province [100]
0
0
Athens
Query!
Country [101]
0
0
Greece
Query!
State/province [101]
0
0
Heraklion Crete
Query!
Country [102]
0
0
Greece
Query!
State/province [102]
0
0
Larissa
Query!
Country [103]
0
0
Greece
Query!
State/province [103]
0
0
Patras
Query!
Country [104]
0
0
Greece
Query!
State/province [104]
0
0
Thessaloniki
Query!
Country [105]
0
0
Hong Kong
Query!
State/province [105]
0
0
Kowloon
Query!
Country [106]
0
0
Hong Kong
Query!
State/province [106]
0
0
Shatin
Query!
Country [107]
0
0
Ireland
Query!
State/province [107]
0
0
Dublin
Query!
Country [108]
0
0
Ireland
Query!
State/province [108]
0
0
Galway
Query!
Country [109]
0
0
Israel
Query!
State/province [109]
0
0
Haifa
Query!
Country [110]
0
0
Israel
Query!
State/province [110]
0
0
Holon
Query!
Country [111]
0
0
Israel
Query!
State/province [111]
0
0
Jerusalem
Query!
Country [112]
0
0
Israel
Query!
State/province [112]
0
0
Petach Tikva
Query!
Country [113]
0
0
Israel
Query!
State/province [113]
0
0
Ramat-gan
Query!
Country [114]
0
0
Israel
Query!
State/province [114]
0
0
Tel Aviv
Query!
Country [115]
0
0
Israel
Query!
State/province [115]
0
0
Zerifin
Query!
Country [116]
0
0
Italy
Query!
State/province [116]
0
0
Aviano
Query!
Country [117]
0
0
Italy
Query!
State/province [117]
0
0
Novara
Query!
Country [118]
0
0
Italy
Query!
State/province [118]
0
0
Roma
Query!
Country [119]
0
0
Italy
Query!
State/province [119]
0
0
Torino
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Chiba-city
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Chiba
Query!
Country [122]
0
0
Japan
Query!
State/province [122]
0
0
Fukuoka
Query!
Country [123]
0
0
Japan
Query!
State/province [123]
0
0
Hamamatsu City
Query!
Country [124]
0
0
Japan
Query!
State/province [124]
0
0
Hokkaido
Query!
Country [125]
0
0
Japan
Query!
State/province [125]
0
0
Kanazawa
Query!
Country [126]
0
0
Japan
Query!
State/province [126]
0
0
Kita-gun
Query!
Country [127]
0
0
Japan
Query!
State/province [127]
0
0
Maebashi-city
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Mito-city
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Osaka-city
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Osaka
Query!
Country [131]
0
0
Japan
Query!
State/province [131]
0
0
Sakura City
Query!
Country [132]
0
0
Japan
Query!
State/province [132]
0
0
Sayama
Query!
Country [133]
0
0
Japan
Query!
State/province [133]
0
0
Sendai City
Query!
Country [134]
0
0
Japan
Query!
State/province [134]
0
0
Shimizucho Sunto-gun
Query!
Country [135]
0
0
Japan
Query!
State/province [135]
0
0
Suntou-gun
Query!
Country [136]
0
0
Japan
Query!
State/province [136]
0
0
Tokyo
Query!
Country [137]
0
0
Japan
Query!
State/province [137]
0
0
Yamagata City
Query!
Country [138]
0
0
Japan
Query!
State/province [138]
0
0
Yokohama City
Query!
Country [139]
0
0
Japan
Query!
State/province [139]
0
0
Yufu-city
Query!
Country [140]
0
0
Latvia
Query!
State/province [140]
0
0
Riga
Query!
Country [141]
0
0
Lithuania
Query!
State/province [141]
0
0
Kaunas
Query!
Country [142]
0
0
Lithuania
Query!
State/province [142]
0
0
Klaipeda
Query!
Country [143]
0
0
Lithuania
Query!
State/province [143]
0
0
Vilnius
Query!
Country [144]
0
0
Mexico
Query!
State/province [144]
0
0
Durango Durango
Query!
Country [145]
0
0
Mexico
Query!
State/province [145]
0
0
Mexico City Distrito Federal
Query!
Country [146]
0
0
Mexico
Query!
State/province [146]
0
0
Zapopan Jalisco
Query!
Country [147]
0
0
Netherlands
Query!
State/province [147]
0
0
Amsterdam
Query!
Country [148]
0
0
Netherlands
Query!
State/province [148]
0
0
Arnhem
Query!
Country [149]
0
0
Netherlands
Query!
State/province [149]
0
0
Breda
Query!
Country [150]
0
0
Netherlands
Query!
State/province [150]
0
0
Eindhoven
Query!
Country [151]
0
0
Netherlands
Query!
State/province [151]
0
0
Heerlen
Query!
Country [152]
0
0
Netherlands
Query!
State/province [152]
0
0
Nieuwegein
Query!
Country [153]
0
0
Netherlands
Query!
State/province [153]
0
0
Nijmegen
Query!
Country [154]
0
0
Netherlands
Query!
State/province [154]
0
0
Rotterdam
Query!
Country [155]
0
0
New Zealand
Query!
State/province [155]
0
0
Auckland
Query!
Country [156]
0
0
New Zealand
Query!
State/province [156]
0
0
Christchurch
Query!
Country [157]
0
0
New Zealand
Query!
State/province [157]
0
0
Dunedin
Query!
Country [158]
0
0
New Zealand
Query!
State/province [158]
0
0
Takapuna
Query!
Country [159]
0
0
New Zealand
Query!
State/province [159]
0
0
Tauranga
Query!
Country [160]
0
0
Peru
Query!
State/province [160]
0
0
Lima
Query!
Country [161]
0
0
Poland
Query!
State/province [161]
0
0
Bielsko-biala
Query!
Country [162]
0
0
Poland
Query!
State/province [162]
0
0
Wroclaw
Query!
Country [163]
0
0
Portugal
Query!
State/province [163]
0
0
Liepaja
Query!
Country [164]
0
0
Portugal
Query!
State/province [164]
0
0
Lisboa
Query!
Country [165]
0
0
Portugal
Query!
State/province [165]
0
0
Porto
Query!
Country [166]
0
0
Puerto Rico
Query!
State/province [166]
0
0
San Juan
Query!
Country [167]
0
0
Romania
Query!
State/province [167]
0
0
Bucharest
Query!
Country [168]
0
0
Romania
Query!
State/province [168]
0
0
Cluj-napoca
Query!
Country [169]
0
0
Russian Federation
Query!
State/province [169]
0
0
Moscow
Query!
Country [170]
0
0
Russian Federation
Query!
State/province [170]
0
0
St Petersburg
Query!
Country [171]
0
0
Singapore
Query!
State/province [171]
0
0
Singapore
Query!
Country [172]
0
0
Slovakia
Query!
State/province [172]
0
0
Nitra
Query!
Country [173]
0
0
Slovakia
Query!
State/province [173]
0
0
Presov
Query!
Country [174]
0
0
Slovakia
Query!
State/province [174]
0
0
Trencin
Query!
Country [175]
0
0
Slovakia
Query!
State/province [175]
0
0
Zilina
Query!
Country [176]
0
0
South Africa
Query!
State/province [176]
0
0
Cape Town
Query!
Country [177]
0
0
South Africa
Query!
State/province [177]
0
0
Durban
Query!
Country [178]
0
0
South Africa
Query!
State/province [178]
0
0
George
Query!
Country [179]
0
0
South Africa
Query!
State/province [179]
0
0
Port Elizabeth
Query!
Country [180]
0
0
Spain
Query!
State/province [180]
0
0
Barcelona
Query!
Country [181]
0
0
Spain
Query!
State/province [181]
0
0
La Coruna
Query!
Country [182]
0
0
Spain
Query!
State/province [182]
0
0
Madrid
Query!
Country [183]
0
0
Spain
Query!
State/province [183]
0
0
Majadahonda
Query!
Country [184]
0
0
Spain
Query!
State/province [184]
0
0
Pamplona
Query!
Country [185]
0
0
Spain
Query!
State/province [185]
0
0
Sevilla
Query!
Country [186]
0
0
Spain
Query!
State/province [186]
0
0
Valencia
Query!
Country [187]
0
0
Sweden
Query!
State/province [187]
0
0
Goteborg
Query!
Country [188]
0
0
Sweden
Query!
State/province [188]
0
0
Stockholm
Query!
Country [189]
0
0
Sweden
Query!
State/province [189]
0
0
Uppsala
Query!
Country [190]
0
0
Switzerland
Query!
State/province [190]
0
0
Aarau
Query!
Country [191]
0
0
Switzerland
Query!
State/province [191]
0
0
Lausanne
Query!
Country [192]
0
0
Switzerland
Query!
State/province [192]
0
0
Winterthur
Query!
Country [193]
0
0
Switzerland
Query!
State/province [193]
0
0
Zurich
Query!
Country [194]
0
0
Taiwan
Query!
State/province [194]
0
0
Taichung
Query!
Country [195]
0
0
Taiwan
Query!
State/province [195]
0
0
Taipei
Query!
Country [196]
0
0
Ukraine
Query!
State/province [196]
0
0
Dnipropetrovsk
Query!
Country [197]
0
0
Ukraine
Query!
State/province [197]
0
0
Donetsk
Query!
Country [198]
0
0
Ukraine
Query!
State/province [198]
0
0
Kyiv
Query!
Country [199]
0
0
Ukraine
Query!
State/province [199]
0
0
Zaporizhzhya
Query!
Country [200]
0
0
United Kingdom
Query!
State/province [200]
0
0
Aberdeen
Query!
Country [201]
0
0
United Kingdom
Query!
State/province [201]
0
0
Belfast
Query!
Country [202]
0
0
United Kingdom
Query!
State/province [202]
0
0
Bristol
Query!
Country [203]
0
0
United Kingdom
Query!
State/province [203]
0
0
Cottingham
Query!
Country [204]
0
0
United Kingdom
Query!
State/province [204]
0
0
Coventry
Query!
Country [205]
0
0
United Kingdom
Query!
State/province [205]
0
0
Glasgow
Query!
Country [206]
0
0
United Kingdom
Query!
State/province [206]
0
0
London
Query!
Country [207]
0
0
United Kingdom
Query!
State/province [207]
0
0
Manchester
Query!
Country [208]
0
0
United Kingdom
Query!
State/province [208]
0
0
Northwood
Query!
Country [209]
0
0
United Kingdom
Query!
State/province [209]
0
0
Preston
Query!
Country [210]
0
0
United Kingdom
Query!
State/province [210]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Millennium Pharmaceuticals, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)
Query!
Trial website
https://clinicaltrials.gov/study/NCT01193244
Query!
Trial related presentations / publications
Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22. Suri A, Chapel S, Lu C, Venkatakrishnan K. Physiologically based and population PK modeling in optimizing drug development: A predict-learn-confirm analysis. Clin Pharmacol Ther. 2015 Sep;98(3):336-44. doi: 10.1002/cpt.155. Epub 2015 Jul 14. Saad F, Fizazi K, Jinga V, Efstathiou E, Fong PC, Hart LL, Jones R, McDermott R, Wirth M, Suzuki K, MacLean DB, Wang L, Akaza H, Nelson J, Scher HI, Dreicer R, Webb IJ, de Wit R; ELM-PC 4 investigators. Orteronel plus prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (ELM-PC 4): a double-blind, multicentre, phase 3, randomised, placebo-controlled trial. Lancet Oncol. 2015 Mar;16(3):338-48. doi: 10.1016/S1470-2045(15)70027-6. Epub 2015 Feb 18.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Monitor
Query!
Address
0
0
Millennium Pharmaceuticals, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
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 are available at
https://clinicaltrials.gov/study/NCT01193244
Download to PDF