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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01193244
First Posted: September 1, 2010
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )
Results First Submitted: April 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Orteronel
Drug: Placebo
Drug: Prednisone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 324 investigative sites in North America, Europe, Australia, Brazil, Chile, Colombia, Hong Kong, Peru, Puerto Rico, Israel, Japan, Mexico, New Zealand, Singapore, South Africa, and Taiwan from 19 October 2010 to 7 April 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Male participants who were chemotherapy-naive and had metastatic castration-resistant prostate cancer (mCRPC) with documented progressive metastatic disease were enrolled in 1 of 2 treatment groups to receive Orteronel 400 milligram (mg) + Prednisone 5 mg or Placebo + Prednisone 5 mg.

Reporting Groups
  Description
Placebo + Prednisone 5 mg Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg + Prednisone 5 mg Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.

Participant Flow:   Overall Study
    Placebo + Prednisone 5 mg   Orteronel 400 mg + Prednisone 5 mg
STARTED   779   781 
Treated   770 [1]   784 [2] 
COMPLETED   391   391 
NOT COMPLETED   388   390 
Withdrawal by Subject                79                97 
Other                303                278 
Lost to Follow-up                6                15 
[1] Participants who continued to receive Placebo after unblinding.
[2] Participants randomized to receive Placebo but crossed-over to receive Orteronel after unblinding.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) population included all participants who were randomized.

Reporting Groups
  Description
Placebo + Prednisone 5 mg Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
Orteronel 400 mg + Prednisone 5 mg Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
Total Total of all reporting groups

Baseline Measures
   Placebo + Prednisone 5 mg   Orteronel 400 mg + Prednisone 5 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 779   781   1560 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.1  (8.19)   70.9  (8.26)   71.0  (8.22) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      779 100.0%      781 100.0%      1560 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      90  11.6%      107  13.7%      197  12.6% 
Not Hispanic or Latino      672  86.3%      669  85.7%      1341  86.0% 
Unknown or Not Reported      17   2.2%      5   0.6%      22   1.4% 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   10   12   22 
Asian   51   38   89 
Native Hawaiian or Other Pacific Islander   2   1   3 
Black or African American   19   25   44 
White   670   685   1355 
Unknown or Not Reported   12   3   15 
Other   15   17   32 
Region of Enrollment 
[Units: Participants]
     
Canada   22   22   44 
United States   147   148   295 
Austria   12   12   24 
Belarus   6   10   16 
Belgium   18   21   39 
Bulgaria   6   6   12 
Croatia   5   1   6 
Czech Republic   13   18   31 
Estonia   2   4   6 
Finland   9   4   13 
France   66   55   121 
Germany   29   40   69 
Greece   23   16   39 
Hungary   3   4   7 
Ireland   11   13   24 
Italy   10   8   18 
Latvia   12   14   26 
Lithuania   19   18   37 
Netherlands   35   38   73 
Poland   0   4   4 
Portugal   4   4   8 
Romania   20   13   33 
Slovakia   9   11   20 
Spain   14   12   26 
Sweden   11   6   17 
Switzerland   10   8   18 
Ukraine   25   23   48 
United Kingdom   42   53   95 
Australia   27   27   54 
Brazil   41   50   91 
Chile   20   20   40 
Colombia   3   6   9 
Hong Kong   1   3   4 
Israel   14   4   18 
Japan   22   18   40 
Mexico   7   9   16 
New Zealand   25   26   51 
Peru   6   10   16 
Puerto Rico   1   1   2 
Singapore   5   2   7 
South Africa   6   4   10 
Taiwan, Province Of China   12   10   22 
Russia   6   5   11 
Height [1] 
[Units: Centimeter]
Mean (Standard Deviation)
 172.77  (7.485)   173.26  (7.858)   173.02  (7.675) 
[1] Height data was available for 1558 participants as follows: n= 778, 780.
Weight [1] 
[Units: Kilogram]
Mean (Standard Deviation)
 84.04  (15.846)   85.09  (16.286)   84.57  (16.071) 
[1] Weight data was available for 1559 participants as follows: n= 778, 781.
Body Mass Index (BMI) [1] 
[Units: Kilogram per square meter (kg/m^2)]
Mean (Standard Deviation)
 28.09  (4.651)   28.28  (4.730)   28.19  (4.690) 
[1] BMI data was available for 1557 participants as follows: n= 777, 780.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Radiographic Progression-free Survival (rPFS)   [ Time Frame: Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years) ]

2.  Primary:   Overall Survival   [ Time Frame: Baseline until death (up to 4.7 years) ]

3.  Secondary:   Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12   [ Time Frame: Week 12 ]

4.  Secondary:   Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12   [ Time Frame: Week 12 ]

5.  Secondary:   Time to Pain Progression   [ Time Frame: Baseline until End of treatment (EOT) (approximately up to 4.7 years) ]

6.  Secondary:   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) ]

7.  Secondary:   Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3   [ Time Frame: Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) ]

8.  Secondary:   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) ]

9.  Secondary:   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) ]

10.  Secondary:   Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status   [ Time Frame: Baseline until EOT (approximately up to 4.7 years) ]

11.  Secondary:   Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings   [ Time Frame: Baseline up to EOT (Cycle 61 Day 58) ]

12.  Secondary:   Worst Change From Baseline Over Time in Cardiac Ejection Fraction   [ Time Frame: Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58) ]

13.  Secondary:   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) ]

14.  Secondary:   Percentage of Participants With Skeletal Related Events (SRE)   [ Time Frame: Baseline up to EOT (approximately up to 4.7 years) ]

15.  Secondary:   Time to SRE   [ Time Frame: Baseline up to EOT (Cycle 61 Day 58) ]

16.  Secondary:   Percentage of Participants Achieving PSA50 Response at Any Time During the Study   [ Time Frame: Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37 ]

17.  Secondary:   Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12   [ Time Frame: Week 12 ]

18.  Secondary:   Percentage of Participants Achieving PSA90 Response at Any Time During the Study   [ Time Frame: Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37 ]

19.  Secondary:   Time to PSA Progression   [ 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) ]

20.  Secondary:   Time to Docetaxel Chemotherapy   [ Time Frame: Baseline until start of docetaxel chemotherapy (up to 4.7 years) ]

21.  Secondary:   Time to Subsequent Antineoplastic Therapy   [ Time Frame: Baseline until start of subsequent antineoplastic therapy (up to 4.7 years) ]

22.  Secondary:   Percentage of Participants With Objective Response   [ Time Frame: Baseline until disease progression or death, whichever occurred first (approximately up to 4.7 years) ]

23.  Secondary:   Time to Deterioration in Global Health Status   [ Time Frame: Baseline until EOT (approximately up to 4.7 years) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT01193244     History of Changes
Other Study ID Numbers: C21004
2010-018661-35 ( EudraCT Number )
0991413276 ( Other Identifier: TCTIP )
10/H0406/75 ( Registry Identifier: NRES )
U1111-1181-0387 ( Registry Identifier: WHO )
First Submitted: August 31, 2010
First Posted: September 1, 2010
Results First Submitted: April 7, 2017
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017