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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01193257
Registration number
NCT01193257
Ethics application status
Date submitted
31/08/2010
Date registered
1/09/2010
Date last updated
19/12/2018
Titles & IDs
Public title
Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
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Scientific title
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy.
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Secondary ID [1]
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2010-018662-23
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Secondary ID [2]
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C21005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Orteronel
Treatment: Drugs - Prednisone
Treatment: Drugs - Orteronel Placebo
Experimental: Orteronel + prednisone -
Placebo comparator: Placebo + prednisone -
Treatment: Drugs: Orteronel
Orteronel tablets
Treatment: Drugs: Prednisone
Prednisone tablets
Treatment: Drugs: Orteronel Placebo
Orteronel placebo-matching tablets
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline until death (approximately up to 4.5 years)
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Secondary outcome [1]
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Radiographic Progression-free Survival (rPFS)
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Assessment method [1]
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rPFS was defined as the time from randomization until radiographic disease progression or death due to any cause, whichever occurred first. Radiographic disease progression was defined as the occurrence of 1 or more of the following: The appearance of 2 or more new lesions on radionuclide bone scan as defined by prostate cancer working group (PCWG)2; Should 2 or more new bone lesions be evident at the first assessment (8-week assessment) on treatment, 2 or more additional new lesions must have been evident on a confirmatory assessment at least 6 weeks later; One or more new soft tissue/visceral organ lesions identified by computed tomography (CT)/magnetic resonance imaging (MRI); Progression as defined by response evaluation criteria in solid tumors (RECIST) 1.1 criteria.
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Timepoint [1]
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Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
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Secondary outcome [2]
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Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12
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Assessment method [2]
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The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50 percent (%) from baseline.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Percentage of Participants With Pain Response at Week 12
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Assessment method [3]
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Pain response 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: A greater than or equal to (\>=) 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use; or a 25 percent (%) or more reduction in analgesic use from baseline without an increase in worst pain score from baseline.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
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Assessment method [4]
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Timepoint [4]
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Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
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Secondary outcome [5]
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Number of Participants With Abnormal Physical Examination Findings
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Assessment method [5]
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Timepoint [5]
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Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
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Secondary outcome [6]
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Number of Participants With TEAEs Related to Vital Signs
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Assessment method [6]
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Timepoint [6]
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Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
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Secondary outcome [7]
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Number of Participants With TEAEs Related to Weight
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Assessment method [7]
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Timepoint [7]
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Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
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Secondary outcome [8]
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Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status
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Assessment method [8]
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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% 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% 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.
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Timepoint [8]
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Baseline up to End-of-treatment (EOT) (Cycle 59 Day 58)
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Secondary outcome [9]
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Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings
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Assessment method [9]
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Timepoint [9]
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Cycle 59 Day 58
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Secondary outcome [10]
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Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Steroid Hormone Panel
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Assessment method [10]
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Timepoint [10]
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Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
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Secondary outcome [11]
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Percentage of Participants Achieving PSA50 Response at Any Time During the Study
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Assessment method [11]
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The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline.
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Timepoint [11]
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Cycle: 4, 7, 10, 13, 16, 19, 22, and 25
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Secondary outcome [12]
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Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12
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Assessment method [12]
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The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.
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Timepoint [12]
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Week 12
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Secondary outcome [13]
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Percentage of Participants Achieving PSA90 Response at Any Time During the Study
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Assessment method [13]
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The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.
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Timepoint [13]
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Cycle: 7, 10, 13, 16, 19, 22, and 25
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Secondary outcome [14]
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Best PSA Response at Any Time During the Study
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Assessment method [14]
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The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline. PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.
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Timepoint [14]
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Cycle: 4, 7, 10, 13, 16, 19, 22, and 25
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Secondary outcome [15]
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Time to PSA Progression
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Assessment method [15]
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Time to PSA progression was defined as time from randomization to a PSA increase of 25% 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, above the baseline PSA.
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Timepoint [15]
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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 4.5 years)
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Secondary outcome [16]
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Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC)
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Assessment method [16]
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A favorable CTC count was defined as less than (\<) 5 counts per (/) 7.5 mililiter (mL) in whole blood. An unfavorable CTC count was defined as \>=5 counts/7.5 mL in whole blood.
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Timepoint [16]
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Baseline and EOT (Cycle 59 Day 58)
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Secondary outcome [17]
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Percentage of Participants With Objective Response
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Assessment method [17]
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Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. The overall objective response was defined as a complete response (CR) or partial response (PR). A complete response (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(s) or short axis of lymph nodes.
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Timepoint [17]
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Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
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Secondary outcome [18]
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Time to Pain Progression
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline until EOT visit or until end of short term follow-up, whichever occurred later (approximately up to 4.5 years)
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Secondary outcome [19]
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Time to Pain Response
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Assessment method [19]
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Time to pain response was defined as the time from randomization until first pain response. Pain response 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: A \>= 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. The analysis was performed by Kaplan-Meier method.
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Timepoint [19]
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Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
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Secondary outcome [20]
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Number of Participants With Best Pain Response
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Assessment method [20]
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Best pain response was evaluated in participants who had a pain response across the entire study were summarized by treatment group. The pain response was defined as a \>=2-point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline.
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Timepoint [20]
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Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
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Secondary outcome [21]
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Percentage of Participants With Health-related Quality of Life (HRQOL) Response at Week 12
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Assessment method [21]
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The global health status or quality of life (QOL) was measured as the HRQOL response rate at 12 weeks using the 2-item global health status index of the european organization for research and treatment of cancer-quality of life questionnaire-C30 (EORTC QLQ-C30) instrument. HRQOL response was defined as a 17-point increase from the baseline assessment on the QOL index, after the score had been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional, and social), 1 global health status, 3 symptom scales (fatigue, pain, nausea/vomiting) and 6 single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score representing better level of functioning or greater degree of symptoms.
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Timepoint [21]
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Week 12
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Eligibility
Key inclusion criteria
Each participant must meet all of the following inclusion criteria:
* Voluntary written consent
* Male 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
* Progressive disease during or following 1 or 2 regimens of cytotoxic chemotherapy, 1 of which must have included docetaxel. Must have received greater than or equal to (>=) 360 milligram per square meter (mg/m^2) of docetaxel within a 6-month period. Participants who were clearly intolerant to docetaxel or develop progressive disease before receiving >= 360 mg/m^2 are also eligible if they have received at least 225 mg/m^2 of docetaxel within a 6-month period and meet the other study entry criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Even if surgically sterilized, participants must practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse
* Screening laboratory values as specified in protocol
* Stable medical condition
* Life expectancy of 6 months or more
* Participants who have had up to 2 prior chemotherapy treatments are eligible to participate
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants 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
* Any other therapies for prostate cancer, except for GnRH analogue therapy, must be discontinued 2 weeks before the first dose of study drug
* Radioisotope therapy or external beam radiation therapy within 4 weeks of 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 (Participants who are in long-term follow-up following active treatment in other trials are eligible)
* 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
* Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel
* Uncontrolled nausea, vomiting, or diarrhea despite appropriate medical therapy
* Prostate cancer confined to just the prostrate bed or immediate adjacent tissue
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/11/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/02/2016
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Sample size
Target
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Accrual to date
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Final
1099
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Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS,VIC
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Recruitment hospital [1]
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- Redcliffe
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Recruitment hospital [2]
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- Woodville South
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Recruitment hospital [3]
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- Hobart
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Recruitment hospital [4]
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- Malvere
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Recruitment hospital [5]
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- Wodonga
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Recruitment postcode(s) [1]
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- Redcliffe
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Recruitment postcode(s) [2]
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5011 - Woodville South
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Recruitment postcode(s) [3]
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- Hobart
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Recruitment postcode(s) [4]
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- Malvere
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Recruitment postcode(s) [5]
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- Wodonga
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alaska
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Florida
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Indiana
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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State/province [8]
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Michigan
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United States of America
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State/province [9]
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Missouri
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United States of America
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State/province [10]
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Nevada
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United States of America
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New Jersey
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United States of America
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State/province [12]
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New York
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United States of America
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State/province [13]
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North Carolina
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United States of America
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Ohio
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United States of America
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State/province [15]
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Oregon
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United States of America
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State/province [16]
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Belgium
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Brussels
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Belgium
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Kortijk
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Belgium
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Liege
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Belgium
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Namur
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Hradec Dralove
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Czechia
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Kromertz
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Czechia
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Modrice
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Czechia
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Praha
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Czechia
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Zlin
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Estonia
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Tallinn
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Finland
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Oulu
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Finland
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Tampere
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France
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La Roche-sur-Yon
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France
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Le Mans
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France
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Lyon Cedex
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France
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Lyon
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France
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Marseille
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France
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Paris
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France
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Villejuif cedex
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Greece
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Patras
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Hungary
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Miskolc
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Hungary
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Osztaly
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Italy
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Novara
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Italy
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Rome
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Netherlands
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Eindhoven
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Poland
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Bielsko-Biala
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Poland
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Goczalkowice-Zdroj
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Poland
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Wroclaw
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Spain
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Millennium Pharmaceuticals, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy
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Trial website
https://clinicaltrials.gov/study/NCT01193257
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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. Fizazi K, Jones R, Oudard S, Efstathiou E, Saad F, de Wit R, De Bono J, Cruz FM, Fountzilas G, Ulys A, Carcano F, Agarwal N, Agus D, Bellmunt J, Petrylak DP, Lee SY, Webb IJ, Tejura B, Borgstein N, Dreicer R. Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5. J Clin Oncol. 2015 Mar 1;33(7):723-31. doi: 10.1200/JCO.2014.56.5119. Epub 2015 Jan 26.
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Contacts
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Medical Monitor
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Millennium Pharmaceuticals, Inc.
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Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT01193257
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