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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Orteronel

Prednisone

Orteronel Placebo

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Drug therapy

Eligibility Criteria

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

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

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

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

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

Radiographic Progression-free Survival (rPFS)

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.

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

The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50 percent (%) from baseline.

Percentage of Participants With Pain Response at Week 12

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.

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

Number of Participants With Abnormal Physical Examination Findings

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% 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.

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

Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Steroid Hormone Panel

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

The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline.

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

The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.

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

The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.

Best PSA Response at Any Time During the Study

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.

Time to PSA Progression

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.

Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC)

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.

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. 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.

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.

Time to Pain Response

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.

Number of Participants With Best Pain Response

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.

Percentage of Participants With Health-related Quality of Life (HRQOL) Response at Week 12

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.

Full Information

NCT ID

NCT01193257

First Posted

August 31, 2010

Last Updated

November 28, 2018

Sponsor

Millennium Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01193257

Brief Title

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

Official 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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

November 15, 2010 (Actual)

Primary Completion Date

May 16, 2013 (Actual)

Study Completion Date

February 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

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

Prostate Cancer

Keywords

Drug therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1099 (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

Other Intervention Name(s)

TAK-700

Intervention Description

Orteronel tablets

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Prednisone tablets

Intervention Type

Drug

Intervention Name(s)

Orteronel Placebo

Intervention Description

Orteronel placebo-matching tablets

Primary Outcome Measure Information:

Title

Overall Survival

Description

Time Frame

Baseline until death (approximately up to 4.5 years)

Secondary Outcome Measure Information:

Title

Radiographic Progression-free Survival (rPFS)

Description

Time Frame

Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)

Title

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

Description

The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50 percent (%) from baseline.

Time Frame

Week 12

Title

Percentage of Participants With Pain Response at Week 12

Description

Time Frame

Week 12

Title

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

Time Frame

Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)

Title

Number of Participants With Abnormal Physical Examination Findings

Time Frame

Baseline up to 30 days after last dose of study drug (Cycle 59 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 59 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 59 Day 58)

Title

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

Description

Time Frame

Baseline up to End-of-treatment (EOT) (Cycle 59 Day 58)

Title

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

Time Frame

Cycle 59 Day 58

Title

Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Steroid Hormone Panel

Time Frame

Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)

Title

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

Description

The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline.

Time Frame

Cycle: 4, 7, 10, 13, 16, 19, 22, and 25

Title

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

Description

The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.

Time Frame

Week 12

Title

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

Description

The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.

Time Frame

Cycle: 7, 10, 13, 16, 19, 22, and 25

Title

Best PSA Response at Any Time During the Study

Description

Time Frame

Cycle: 4, 7, 10, 13, 16, 19, 22, and 25

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 4.5 years)

Title

Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC)

Description

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.

Time Frame

Baseline and EOT (Cycle 59 Day 58)

Title

Percentage of Participants With Objective Response

Description

Time Frame

Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)

Title

Time to Pain Progression

Description

Time Frame

Baseline until EOT visit or until end of short term follow-up, whichever occurred later (approximately up to 4.5 years)

Title

Time to Pain Response

Description

Time Frame

Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)

Title

Number of Participants With Best Pain Response

Description

Time Frame

Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)

Title

Percentage of Participants With Health-related Quality of Life (HRQOL) Response at Week 12

Description

Time Frame

Week 12

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

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

State/Province

Alaska

ZIP/Postal Code

99508

Country

United States

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72903

Country

United States

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

City

Riverside

State/Province

California

ZIP/Postal Code

92501

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

City

Port Saint Lucie

State/Province

Florida

ZIP/Postal Code

34952

Country

United States

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46219

Country

United States

City

Jeffersonville

State/Province

Indiana

ZIP/Postal Code

47130

Country

United States

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

City

Westminster

State/Province

Maryland

ZIP/Postal Code

21157

Country

United States

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

City

Jefferson City

State/Province

Missouri

ZIP/Postal Code

65109

Country

United States

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

City

East Syracuse

State/Province

New York

ZIP/Postal Code

13057

Country

United States

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45230

Country

United States

City

Tualatin

State/Province

Oregon

ZIP/Postal Code

97062

Country

United States

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17604

Country

United States

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

City

Odessa

State/Province

Texas

ZIP/Postal Code

79761

Country

United States

City

Tyler

State/Province

Texas

ZIP/Postal Code

75702

Country

United States

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

City

Salt Lake City

State/Province

Utah

Country

United States

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

City

Kennewick

State/Province

Washington

ZIP/Postal Code

99336

Country

United States

City

Redcliffe

State/Province

Queensland

Country

Australia

City

Woodville South

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

City

Hobart

State/Province

Tasmania

Country

Australia

City

Malvere

State/Province

Victoria

Country

Australia

City

Wodonga

State/Province

Victoria

Country

Australia

City

Brussels

Country

Belgium

City

Kortijk

Country

Belgium

City

Liege

Country

Belgium

City

Namur

Country

Belgium

City

Edmonton

State/Province

Alberta

Country

Canada

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y2H4

Country

Canada

City

Moncton

State/Province

New Brunswick

Country

Canada

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T4S5

Country

Canada

City

Newmarket

State/Province

Ontario

Country

Canada

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V2H3

Country

Canada

City

Montreal

State/Province

Quebec

Country

Canada

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R4S3

Country

Canada

City

Hradec Dralove

Country

Czechia

City

Kromertz

Country

Czechia

City

Modrice

Country

Czechia

City

Praha

Country

Czechia

City

Zlin

Country

Czechia

City

Tallinn

Country

Estonia

City

Oulu

Country

Finland

City

Tampere

Country

Finland

City

La Roche-sur-Yon

Country

France

City

Le Mans

Country

France

City

Lyon Cedex

Country

France

City

Lyon

Country

France

City

Marseille

Country

France

City

Paris

Country

France

City

Villejuif cedex

ZIP/Postal Code

94805

Country

France

City

Patras

Country

Greece

City

Miskolc

Country

Hungary

City

Osztaly

Country

Hungary

City

Novara

Country

Italy

City

Rome

Country

Italy

City

Eindhoven

Country

Netherlands

City

Bielsko-Biala

Country

Poland

City

Goczalkowice-Zdroj

Country

Poland

City

Wroclaw

Country

Poland

City

Sevilla

Country

Spain

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

25624429

Citation

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.

Results Reference

derived

Learn more about this trial

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

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