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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01193244




Registration number
NCT01193244
Ethics application status
Date submitted
31/08/2010
Date registered
1/09/2010
Date last updated
17/05/2017

Titles & IDs
Public title
Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
Scientific title
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
Secondary ID [1] 0 0
2010-018661-35
Secondary ID [2] 0 0
C21004
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Orteronel
Treatment: Drugs - Placebo
Treatment: Drugs - Prednisone

Experimental: Orteronel + prednisone -

Placebo comparator: Placebo + prednisone -


Treatment: Drugs: Orteronel
Orteronel will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of \<50 ng/dL.

Treatment: Drugs: Placebo
Placebo will be administered orally twice a day continuously throughout the study. Additionally, all patients will receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and a testosterone concentration of \<50 ng/dL.

Treatment: Drugs: Prednisone
Prednisone will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of \<50 ng/dL.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression-free Survival (rPFS)
Timepoint [1] 0 0
Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years)
Primary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
Baseline until death (up to 4.7 years)
Secondary outcome [1] 0 0
Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Time to Pain Progression
Timepoint [3] 0 0
Baseline until End of treatment (EOT) (approximately up to 4.7 years)
Secondary outcome [4] 0 0
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [4] 0 0
Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)
Secondary outcome [5] 0 0
Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3
Timepoint [5] 0 0
Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)
Secondary outcome [6] 0 0
Number of Participants With TEAEs Related to Vital Signs
Timepoint [6] 0 0
Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)
Secondary outcome [7] 0 0
Number of Participants With TEAEs Related to Weight
Timepoint [7] 0 0
Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)
Secondary outcome [8] 0 0
Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status
Timepoint [8] 0 0
Baseline until EOT (approximately up to 4.7 years)
Secondary outcome [9] 0 0
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings
Timepoint [9] 0 0
Baseline up to EOT (Cycle 61 Day 58)
Secondary outcome [10] 0 0
Worst Change From Baseline Over Time in Cardiac Ejection Fraction
Timepoint [10] 0 0
Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)
Secondary outcome [11] 0 0
Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation
Timepoint [11] 0 0
Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)
Secondary outcome [12] 0 0
Percentage of Participants With Skeletal Related Events (SRE)
Timepoint [12] 0 0
Baseline up to EOT (approximately up to 4.7 years)
Secondary outcome [13] 0 0
Time to SRE
Timepoint [13] 0 0
Baseline up to EOT (Cycle 61 Day 58)
Secondary outcome [14] 0 0
Percentage of Participants Achieving PSA50 Response at Any Time During the Study
Timepoint [14] 0 0
Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37
Secondary outcome [15] 0 0
Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12
Timepoint [15] 0 0
Week 12
Secondary outcome [16] 0 0
Percentage of Participants Achieving PSA90 Response at Any Time During the Study
Timepoint [16] 0 0
Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37
Secondary outcome [17] 0 0
Time to PSA Progression
Timepoint [17] 0 0
Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.7 years)
Secondary outcome [18] 0 0
Time to Docetaxel Chemotherapy
Timepoint [18] 0 0
Baseline until start of docetaxel chemotherapy (up to 4.7 years)
Secondary outcome [19] 0 0
Time to Subsequent Antineoplastic Therapy
Timepoint [19] 0 0
Baseline until start of subsequent antineoplastic therapy (up to 4.7 years)
Secondary outcome [20] 0 0
Percentage of Participants With Objective Response
Timepoint [20] 0 0
Baseline until disease progression or death, whichever occurred first (approximately up to 4.7 years)
Secondary outcome [21] 0 0
Time to Deterioration in Global Health Status
Timepoint [21] 0 0
Baseline until EOT (approximately up to 4.7 years)

Eligibility
Key inclusion criteria
Each patient must meet all of the following inclusion criteria:

* Voluntary written consent
* Male patients 18 years or older
* Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
* Radiograph-documented metastatic disease
* Progressive disease
* Prior surgical castration or concurrent use of an agent for medical castration
* Either absence of pain or pain not requiring use of any opioid or narcotic analgesia in the 2 weeks prior to study entry
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Even if surgically sterilized, patients must practice effective barrier contraception during the entire study treatment and for 4 months after the last dose of study drug, OR abstain from heterosexual intercourse
* Meet screening laboratory values as specified in protocol
* Stable medical condition
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

* Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue
* Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone
* Received antiandrogen therapy within 6 weeks for bicalutamide and 4 weeks for all others prior to first dose of study drug
* Continuous daily use of oral prednisone or oral dexamethasone for more than 14 days within 3 months prior to study
* Received prior chemotherapy for prostate cancer with exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years prior to screening
* Exposure to radioisotope therapy within 4 weeks of receiving first dose of study drug; exposure to external beam radiation within 2 weeks of start of screening until receiving the first dose of study drug
* Documented central nervous system metastases
* Treatment with any investigational compound within 30 days prior to first dose of study drug
* Current spinal cord compression, bilateral hydronephrosis or current bladder neck outlet obstruction
* Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
* Uncontrolled cardiovascular condition as specified in study protocol
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
* Unwilling or unable to comply with protocol
* Uncontrolled nausea, vomiting or diarrhea
* Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/04/2016
Sample size
Target
Accrual to date
Final
1560
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Hobart
Recruitment hospital [3] 0 0
- Kurralta Park
Recruitment hospital [4] 0 0
- Nedlands
Recruitment hospital [5] 0 0
- Perth
Recruitment hospital [6] 0 0
- Redcliffe
Recruitment hospital [7] 0 0
- Wodonga
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Hobart
Recruitment postcode(s) [3] 0 0
- Kurralta Park
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- Redcliffe
Recruitment postcode(s) [7] 0 0
- Wodonga
Recruitment outside Australia
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United States of America
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Alaska
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Minsk
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Majadahonda
Country [184] 0 0
Spain
State/province [184] 0 0
Pamplona
Country [185] 0 0
Spain
State/province [185] 0 0
Sevilla
Country [186] 0 0
Spain
State/province [186] 0 0
Valencia
Country [187] 0 0
Sweden
State/province [187] 0 0
Goteborg
Country [188] 0 0
Sweden
State/province [188] 0 0
Stockholm
Country [189] 0 0
Sweden
State/province [189] 0 0
Uppsala
Country [190] 0 0
Switzerland
State/province [190] 0 0
Aarau
Country [191] 0 0
Switzerland
State/province [191] 0 0
Lausanne
Country [192] 0 0
Switzerland
State/province [192] 0 0
Winterthur
Country [193] 0 0
Switzerland
State/province [193] 0 0
Zurich
Country [194] 0 0
Taiwan
State/province [194] 0 0
Taichung
Country [195] 0 0
Taiwan
State/province [195] 0 0
Taipei
Country [196] 0 0
Ukraine
State/province [196] 0 0
Dnipropetrovsk
Country [197] 0 0
Ukraine
State/province [197] 0 0
Donetsk
Country [198] 0 0
Ukraine
State/province [198] 0 0
Kyiv
Country [199] 0 0
Ukraine
State/province [199] 0 0
Zaporizhzhya
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Aberdeen
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Belfast
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Bristol
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Cottingham
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Coventry
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Glasgow
Country [206] 0 0
United Kingdom
State/province [206] 0 0
London
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Manchester
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Northwood
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Preston
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Southampton

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Millennium Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01193244