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Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Orteronel

Placebo

Prednisone

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Orteronel + prednisone

Placebo + prednisone

Arm Description

Outcomes

Primary Outcome Measures

Radiographic Progression-free Survival (rPFS)

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.

Overall Survival

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.

Secondary Outcome Measures

Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12

The PSA50 is defined as a decline of at least 50 percent (%) from baseline.

Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12

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.

Time to Pain Progression

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.

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3

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.

Number of Participants With TEAEs Related to Vital Signs

Number of Participants With TEAEs Related to Weight

Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status

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.

Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings

Worst Change From Baseline Over Time in Cardiac Ejection Fraction

Worst change was defined as the worst overall change that occurred in cardiac ejection fraction at any measured time point.

Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation

Percentage of Participants With Skeletal Related Events (SRE)

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.

Time to SRE

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.

Percentage of Participants Achieving PSA50 Response at Any Time During the Study

The PSA50 is defined as a decline of PSA by 50 percent from baseline.

Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12

The PSA90 is defined as a decline of PSA by 90 percent from baseline.

Percentage of Participants Achieving PSA90 Response at Any Time During the Study

The PSA90 is defined as a decline of PSA by 90 percent from baseline.

Time to PSA Progression

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.

Time to Docetaxel Chemotherapy

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.

Time to Subsequent Antineoplastic Therapy

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.

Percentage of Participants With Objective Response

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.

Time to Deterioration in Global Health Status

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).

Full Information

NCT ID

NCT01193244

First Posted

August 31, 2010

Last Updated

April 7, 2017

Sponsor

Millennium Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01193244

Brief Title

Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

October 1, 2010 (Actual)

Primary Completion Date

January 1, 2014 (Actual)

Study Completion Date

April 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Millennium Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1560 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Orteronel + prednisone

Arm Type

Experimental

Arm Title

Placebo + prednisone

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Orteronel

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

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.

Primary Outcome Measure Information:

Title

Radiographic Progression-free Survival (rPFS)

Description

Time Frame

Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years)

Title

Overall Survival

Description

Time Frame

Baseline until death (up to 4.7 years)

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12

Description

The PSA50 is defined as a decline of at least 50 percent (%) from baseline.

Time Frame

Week 12

Title

Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12

Description

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.

Time Frame

Week 12

Title

Time to Pain Progression

Description

Time Frame

Baseline until End of treatment (EOT) (approximately up to 4.7 years)

Title

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time Frame

Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

Title

Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3

Description

Time Frame

Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

Title

Number of Participants With TEAEs Related to Vital Signs

Time Frame

Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

Title

Number of Participants With TEAEs Related to Weight

Time Frame

Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

Title

Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status

Description

Time Frame

Baseline until EOT (approximately up to 4.7 years)

Title

Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings

Time Frame

Baseline up to EOT (Cycle 61 Day 58)

Title

Worst Change From Baseline Over Time in Cardiac Ejection Fraction

Description

Worst change was defined as the worst overall change that occurred in cardiac ejection fraction at any measured time point.

Time Frame

Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)

Title

Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation

Time Frame

Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)

Title

Percentage of Participants With Skeletal Related Events (SRE)

Description

Time Frame

Baseline up to EOT (approximately up to 4.7 years)

Title

Time to SRE

Description

Time Frame

Baseline up to EOT (Cycle 61 Day 58)

Title

Percentage of Participants Achieving PSA50 Response at Any Time During the Study

Description

The PSA50 is defined as a decline of PSA by 50 percent from baseline.

Time Frame

Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37

Title

Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12

Description

The PSA90 is defined as a decline of PSA by 90 percent from baseline.

Time Frame

Week 12

Title

Percentage of Participants Achieving PSA90 Response at Any Time During the Study

Description

The PSA90 is defined as a decline of PSA by 90 percent from baseline.

Time Frame

Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37

Title

Time to PSA Progression

Description

Time Frame

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)

Title

Time to Docetaxel Chemotherapy

Description

Time Frame

Baseline until start of docetaxel chemotherapy (up to 4.7 years)

Title

Time to Subsequent Antineoplastic Therapy

Description

Time Frame

Baseline until start of subsequent antineoplastic therapy (up to 4.7 years)

Title

Percentage of Participants With Objective Response

Description

Time Frame

Baseline until disease progression or death, whichever occurred first (approximately up to 4.7 years)

Title

Time to Deterioration in Global Health Status

Description

Time Frame

Baseline until EOT (approximately up to 4.7 years)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Millennium Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

City

Anchorage

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Alaska

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Tucson

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Arizona

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Duarte

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Highland

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Orange

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Sacramento

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San Francisco

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Denver

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Orlando

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Port St Lucie

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Corinth

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Omaha

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Las Vegas

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Hackensack

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East Syracuse

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New York

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Durham

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Raleigh

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Kettering

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Hershey

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Piitsburgh

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Charleston

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Columbia

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Chattanooga

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Nashville

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Amarillo

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Bedford

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Dallas

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Denton

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Tyler

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Salt Lake City

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Utah

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Norfolk

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Virginia

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Garran

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Australia

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Hobart

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Australia

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Kurralta Park

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Australia

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Nedlands

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Perth

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Redcliffe

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Wodonga

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Graz

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Linz

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Wien

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Minsk

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Edegem

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Hasselt

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Kortrijk

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Leuven

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Namur

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Belgium

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Bairro Nazare - Salvador

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Barretos/sp

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Belo Horizonte

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Campinas

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Caxias Do Sul

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Curitiba

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Ijui

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Joinville

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Lajeado - Rs

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Piracicaba - Sp

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Porto Alegre- Rs

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Porto Alegre/rs

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Ribeirao Preto - Sp

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Rio de Janeiro Rj

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Rio de Janeiro

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Santo Andre

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Sao Jose Do Rio Preto

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Sao Jose Dos Campos

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Sao Paulo

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Sorocaba - Sp

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Plovdiv

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Bulgaria

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Sofia

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Varna

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Kelowna

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Burlington

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Ontario

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Hamilton

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London

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Owen Sound

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Toronto

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Montreal

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Pointe Claire

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Quebec City

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Quebec

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Sherbrooke

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Las Condes

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Chile

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Santiago

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Temuco

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Valparaiso

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Chile

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Cali

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Colombia

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Hradec Kralove

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Czech Republic

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Praha 4

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Czech Republic

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Praha 5

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Czech Republic

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Joensuu

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Finland

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Oulu

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Finland

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Seinajoki

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Finland

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Tampere

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Finland

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Angers

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France

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Bordeaux

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France

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Caen

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Creteil

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France

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La Roche Sur Yon

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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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Nancy

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France

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Nantes

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France

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Paris Cedex 13

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France

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Paris Cedex 14

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France

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Paris

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France

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Poitiers

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France

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Saint-etienne

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France

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Villejuif

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France

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Braunschweig

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Germany

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Dresden

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Germany

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Hamburg

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Germany

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Hannover

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Germany

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Kassel

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Germany

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Kempen

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Germany

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Nurtingen

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Germany

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Tubingen

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Germany

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Wuppertal

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Germany

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Athens

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Greece

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Heraklion Crete

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Greece

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Larissa

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Greece

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Patras

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Greece

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Thessaloniki

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Greece

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Kowloon

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Hong Kong

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Shatin

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Hong Kong

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Dublin

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Ireland

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Galway

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Ireland

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Haifa

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Israel

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Holon

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Israel

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Jerusalem

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Israel

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Petach Tikva

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Israel

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Ramat-gan

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Israel

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Tel Aviv

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Israel

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Zerifin

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Israel

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Aviano

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Italy

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Novara

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Italy

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Roma

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Italy

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Torino

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Italy

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Chiba-city

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Japan

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Chiba

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Japan

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Fukuoka

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Japan

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Hamamatsu City

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Japan

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Hokkaido

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Japan

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Kanazawa

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Japan

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Kita-gun

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Japan

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Maebashi-city

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Japan

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Mito-city

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Japan

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Osaka-city

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Japan

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Osaka

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Japan

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Sakura City

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Japan

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Sayama

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Japan

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Sendai City

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Japan

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Shimizucho Sunto-gun

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Japan

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Suntou-gun

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Japan

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Tokyo

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Japan

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Yamagata City

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Japan

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Yokohama City

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Japan

City

Yufu-city

Country

Japan

City

Riga

Country

Latvia

City

Kaunas

Country

Lithuania

City

Klaipeda

Country

Lithuania

City

Vilnius

Country

Lithuania

City

Durango Durango

Country

Mexico

City

Mexico City Distrito Federal

Country

Mexico

City

Zapopan Jalisco

Country

Mexico

City

Amsterdam

Country

Netherlands

City

Arnhem

Country

Netherlands

City

Breda

Country

Netherlands

City

Eindhoven

Country

Netherlands

City

Heerlen

Country

Netherlands

City

Nieuwegein

Country

Netherlands

City

Nijmegen

Country

Netherlands

City

Rotterdam

Country

Netherlands

City

Auckland

Country

New Zealand

City

Christchurch

Country

New Zealand

City

Dunedin

Country

New Zealand

City

Takapuna

Country

New Zealand

City

Tauranga

Country

New Zealand

City

Lima

Country

Peru

City

Bielsko-biala

Country

Poland

City

Wroclaw

Country

Poland

City

Liepaja

Country

Portugal

City

Lisboa

Country

Portugal

City

Porto

Country

Portugal

City

San Juan

Country

Puerto Rico

City

Bucharest

Country

Romania

City

Cluj-napoca

Country

Romania

City

Moscow

Country

Russian Federation

City

St Petersburg

Country

Russian Federation

City

Singapore

Country

Singapore

City

Nitra

Country

Slovakia

City

Presov

Country

Slovakia

City

Trencin

Country

Slovakia

City

Zilina

Country

Slovakia

City

Cape Town

Country

South Africa

City

Durban

Country

South Africa

City

George

Country

South Africa

City

Port Elizabeth

Country

South Africa

City

Barcelona

Country

Spain

City

La Coruna

Country

Spain

City

Madrid

Country

Spain

City

Majadahonda

Country

Spain

City

Pamplona

Country

Spain

City

Sevilla

Country

Spain

City

Valencia

Country

Spain

City

Goteborg

Country

Sweden

City

Stockholm

Country

Sweden

City

Uppsala

Country

Sweden

City

Aarau

Country

Switzerland

City

Lausanne

Country

Switzerland

City

Winterthur

Country

Switzerland

City

Zurich

Country

Switzerland

City

Taichung

Country

Taiwan

City

Taipei

Country

Taiwan

City

Dnipropetrovsk

Country

Ukraine

City

Donetsk

Country

Ukraine

City

Kyiv

Country

Ukraine

City

Zaporizhzhya

Country

Ukraine

City

Aberdeen

Country

United Kingdom

City

Belfast

Country

United Kingdom

City

Bristol

Country

United Kingdom

City

Cottingham

Country

United Kingdom

City

Coventry

Country

United Kingdom

City

Glasgow

Country

United Kingdom

City

London

Country

United Kingdom

City

Manchester

Country

United Kingdom

City

Northwood

Country

United Kingdom

City

Preston

Country

United Kingdom

City

Southampton

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29272162

Citation

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.

Results Reference

derived

PubMed Identifier

26031410

Citation

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.

Results Reference

derived

PubMed Identifier

25701170

Citation

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.

Results Reference

derived

Learn more about this trial

Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

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