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Safety and Efficacy of TAK-385 for Patients With Localized Prostate Cancer

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.
 
ClinicalTrials.gov Identifier: NCT02135445
Recruitment Status : Completed
First Posted : May 12, 2014
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: TAK-385
Drug: Degarelix
Enrollment 103
Recruitment Details Participants took part in the study at 23 investigative sites in the United States (US) and the United Kingdom (UK).
Pre-assignment Details Participants with a diagnosis of localized prostate cancer were enrolled in 1 of the 2 treatment groups to receive TAK-385 120 milligram (mg) or degarelix 80 mg.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24. Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Period Title: Overall Study
Started 65 38
Completed 63 38
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             1             0
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg Total
Hide Arm/Group Description TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24. Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21. Total of all reporting groups
Overall Number of Baseline Participants 65 38 103
Hide Baseline Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
18 to 64 years 9 7 16
65 to 84 years 55 31 86
Greater than or equal to (>=) 85 years 1 0 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
65
 100.0%
38
 100.0%
103
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
Hispanic or Latino
2
   3.1%
3
   7.9%
5
   4.9%
Not Hispanic or Latino
62
  95.4%
35
  92.1%
97
  94.2%
Unknown or Not Reported
1
   1.5%
0
   0.0%
1
   1.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
White 58 31 89
Black or African American 7 7 14
Eastern Cooperative Oncology Group (ECOG) Performance status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
Grade 0 60 33 93
Grade 1 4 4 8
Missing 1 1 2
[1]
Measure Description: ECOG assessed participants performance status on a 6-point scale: 0: Fully active, able to carry on all predisease performance without restriction; 1: Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature; 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about greater than (>)50 percent (%) of waking hours; 3:Capable of limited selfcare,confined to bed or chair >50% of waking hours; 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair; 5:Dead.
Prostate Cancer Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
Adenocarcinoma insitu,Not otherwise specified(NOS) 5 1 6
Adenocarcinoma, NOS 59 37 96
Other 1 0 1
Primary Gleason Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
Primary grade 3 28 18 46
Primary grade 4 24 15 39
Primary grade missing 13 5 18
[1]
Measure Description: Gleason score is a histological score that, together with other clinical factors may be used to predict the potential aggressiveness of the cancer and thus its risk of eventually spreading. Gleason scores range from 2-10, where 2-4: lower risk; 5-6: moderate risk; 8-10: higher risk with lower score representing most well-differentiated tumors and higher score representing least-differentiated tumors. Primary grading in Gleason score is assigned to dominant pattern of tumor which has to be >50% of total pattern seen.
Secondary Gleason Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
Secondary grade 3 22 12 34
Secondary grade 4 28 19 47
Secondary grade 5 2 2 4
Secondary grade missing 13 5 18
[1]
Measure Description: Gleason score is a histological score that, together with other clinical factors may be used to predict the potential aggressiveness of the cancer and thus its risk of eventually spreading. Gleason scores range from 2-10, where 2-4: lower risk; 5-6: moderate risk; 8-10: higher risk with lower score representing most well-differentiated tumors and higher score representing least-differentiated tumors. Primary grading in Gleason score is assigned to dominant pattern of tumor which has to be >50% of total pattern seen.
Total Gleason Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
Total Gleason score 6 5 2 7
Total Gleason score 7 40 26 66
Total Gleason score 8 5 3 8
Total Gleason score 9 2 2 4
Total Gleason score missing 13 5 18
[1]
Measure Description: Gleason score is a histological score that, together with other clinical factors may be used to predict the potential aggressiveness of the cancer and thus its risk of eventually spreading. Gleason scores range from 2-10, where 2-4: lower risk; 5-6: moderate risk; 8-10: higher risk with lower score representing most well-differentiated tumors and higher score representing least-differentiated tumors. Primary grading in Gleason score is assigned to dominant pattern of tumor which has to be >50% of total pattern seen.
Initial diagnosis of Primary Tumor (T)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
T1 2 3 5
T1a 0 1 1
T1c 24 16 40
T2 4 4 8
T2a 13 2 15
T2b 7 2 9
T2c 8 7 15
T3 0 2 2
Not available 7 1 8
[1]
Measure Description: TNM Stages: T1: unapparent neither palpable nor visible by imaging, T1a: histologic finding in 5% or less of tissue resected, T1b: histological finding in >5% of tissue resected, T1c: identified by needle biopsy, T2: confined within prostate, T2a: one-half of one lobe or less, T2b: involves more than one-half of one lobe but not both lobes, T2c: involves both lobes, T3: extends through prostate capsule, T3a: Extracapsular extension Including microscopic bladder neck involvement, T3b: invades seminal vesicles, T4: fixed or invades adjacent structures other than seminal vesicles
Initial diagnosis: Regional Lymph Nodes (N)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
N0 41 18 59
NX 16 18 34
Not available 8 2 10
[1]
Measure Description: TNM: Regional lymph nodes (N) staging included NX: Regional lymph nodes were not assessed, and N0: No regional lymph node metastasis.
Initial diagnosis: Distant Metastasis (M)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
M0 56 34 90
Not available 9 4 13
[1]
Measure Description: TNM: Distant metastasis stages included, M0: No distant metastasis.
Diagnosis of Primary Tumor at Study entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
T1 1 1 2
T1a 0 1 1
T1c 20 10 30
T2 6 5 11
T2a 12 3 15
T2b 7 1 8
T2c 7 7 14
T3 0 1 1
T3a 1 0 1
TX 0 1 1
Not available 11 8 19
[1]
Measure Description: TNM Stages: T1: unapparent neither palpable nor visible by imaging, T1a: histologic finding in 5% or less of tissue resected, T1b: histological finding in >5% of tissue resected, T1c: identified by needle biopsy, T2: confined within prostate, T2a: one-half of one lobe or less, T2b: involves more than one-half of one lobe but not both lobes, T2c: involves both lobes, T3: extends through prostate capsule, T3a: Extracapsular extension Including microscopic bladder neck involvement, T3b: invades seminal vesicles, T4: fixed or invades adjacent structures other than seminal vesicles
Study entry: N   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
N0 39 19 58
NX 13 10 23
Not available 13 9 22
[1]
Measure Description: TNM: Regional lymph nodes staging included NX: Regional lymph nodes were not assessed, and N0: No regional lymph node metastasis.
Study entry: M   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 38 participants 103 participants
M0 51 28 79
Not available 14 10 24
[1]
Measure Description: TNM: Distant metastasis stages included, M0: No distant metastasis.
1.Primary Outcome
Title Percentage of Participants With Effective Castration Rate Over 25 Weeks
Hide Description Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter [nmol/L]) at all scheduled visits.
Time Frame Day 1 Week 5 up to Day 1 Week 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95
(87.1 to 99.0)
89
(75.2 to 97.1)
2.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs
Hide Description [Not Specified]
Time Frame Baseline up to Week 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Measure Type: Number
Unit of Measure: participants
2 1
3.Secondary Outcome
Title Number of Participants With TEAEs Related to Physical Findings
Hide Description [Not Specified]
Time Frame Baseline up to Week 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Measure Type: Number
Unit of Measure: participants
5 1
4.Secondary Outcome
Title Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings
Hide Description [Not Specified]
Time Frame Baseline up to Week 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Measure Type: Number
Unit of Measure: participants
1 1
5.Secondary Outcome
Title Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis
Hide Description [Not Specified]
Time Frame Baseline up to Week 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Measure Type: Number
Unit of Measure: participants
Liver function analyses 0 6
Reproductive hormone analyses 2 4
Carbohydrate tolerance analyses inclusive diabetes 1 0
Cell marker analyses 0 1
Platelet analyses 0 1
Red blood cell analyses 1 0
Skeletal and cardiac muscle analyses 1 0
Urinalysis not elsewhere classified (NEC) 1 0
6.Secondary Outcome
Title Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Baseline up to Week 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Measure Type: Number
Unit of Measure: participants
TEAEs (including SAEs and non-SAEs) 56 37
SAEs 1 3
7.Secondary Outcome
Title Average Percent Change in Prostate Size
Hide Description Percent change in prostate size was assessed at a follow up visit between Day 1 Week 9 to Day 1 Week 13.
Time Frame Baseline, Day 1 Week 9 to Day 1 Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 57 38
Mean (Standard Deviation)
Unit of Measure: percent change
-25.1  (20.03) -27.2  (25.88)
8.Secondary Outcome
Title Time to Achieve Effective Castration
Hide Description Time to effective castration is defined as days from first dose to first testosterone measurement that is <50 ng/dL.
Time Frame Baseline up to Week 37
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Median (95% Confidence Interval)
Unit of Measure: days
4
(2 to 4)
3
(2 to 4)
9.Secondary Outcome
Title Time to Achieve Profound Castration
Hide Description Time to profound castration is defined as days from first dose to first testosterone measurement that is <20 ng/dL.
Time Frame Baseline up to Week 37
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Median (95% Confidence Interval)
Unit of Measure: days
15
(8 to 15)
12
(8 to 15)
10.Secondary Outcome
Title Estimated Time to Testosterone Recovery (TTR)
Hide Description TTR is defined as the time from 1 day after the last dose of TAK-385 or 4 weeks plus 1 day after the last dose of degarelix to testosterone recovery. Testosterone recovery is defined as back to baseline or >280 ng/dL whichever occurs first. TTR was determined during 12 weeks after the discontinuation of androgen deprivation therapy (ADT).
Time Frame Up to Day 1 Week 37
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 6
Median (95% Confidence Interval)
Unit of Measure: days
91
(62 to 127)
100
(100 to 106)
11.Secondary Outcome
Title Percentage of Participants Who Have Recovered to Baseline Value of Testosterone
Hide Description [Not Specified]
Time Frame Up to Day 1 Week 37
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Measure Type: Number
Unit of Measure: percentage of participants
25 11
12.Secondary Outcome
Title Percentage of Participants Who Have Recovered to >280 ng/dL Testosterone
Hide Description [Not Specified]
Time Frame Day 1 Week 25 up to Day 1 Week 37
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Measure Type: Number
Unit of Measure: percentage of participants
48 13
13.Secondary Outcome
Title Number of Participants With PSA Response of >=50% and >=90% Reduction
Hide Description Prostate-specific Antigen (PSA) response was defined as 50% and 90% reduction from baseline in serum PSA levels.
Time Frame Day 1 Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Measure Type: Number
Unit of Measure: participants
>=50% reduction 64 37
>=90% reduction 36 18
14.Secondary Outcome
Title Percent Change From Baseline in Serum PSA Concentration
Hide Description [Not Specified]
Time Frame Baseline, Day 1 of Week 2, 3 , 5, 9, 13, 17, 21, 25, 29, 33 and 37
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Mean (Standard Deviation)
Unit of Measure: percent change
Day 1 Week 2 Number Analyzed 64 participants 37 participants
-29.348  (21.9312) -26.756  (36.9407)
Day 1 Week 3 Number Analyzed 65 participants 37 participants
-35.798  (48.5347) -14.292  (108.1051)
Day 1 Week 5 Number Analyzed 65 participants 37 participants
-60.519  (34.9460) -64.509  (32.5843)
Day 1 Week 9 Number Analyzed 62 participants 37 participants
-84.345  (13.7231) -78.364  (42.6674)
Day 1 Week 13 Number Analyzed 64 participants 38 participants
-88.065  (10.6750) -85.735  (14.9181)
Day 1 Week 17 Number Analyzed 64 participants 37 participants
-90.433  (10.0884) -87.712  (13.8226)
Day 1 Week 21 Number Analyzed 63 participants 37 participants
-95.837  (5.0062) -94.347  (9.4243)
Day 1 Week 25 Number Analyzed 64 participants 37 participants
-97.430  (3.3650) -96.268  (7.6796)
Day 1 Week 29 Number Analyzed 61 participants 38 participants
-96.614  (4.7552) -96.858  (7.5198)
Day 1 Week 33 Number Analyzed 62 participants 38 participants
-94.697  (6.4998) -97.309  (7.3210)
Day 1 Week 37 Number Analyzed 61 participants 38 participants
-94.998  (5.6555) -97.144  (6.6127)
15.Secondary Outcome
Title PSA Nadir
Hide Description [Not Specified]
Time Frame Baseline up to Day 1 Week 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Mean (Standard Deviation)
Unit of Measure: microgram per liter (mcg/L)
0.3  (0.72) 0.3  (0.41)
16.Secondary Outcome
Title Serum PSA Concentration
Hide Description [Not Specified]
Time Frame Day 1 of Week 13, 25, 29, 33 and 37
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Mean (Standard Deviation)
Unit of Measure: mcg/L
Day 1 Week 13 Number Analyzed 64 participants 38 participants
1.104  (1.3287) 1.486  (2.1381)
Day 1 Week 25 Number Analyzed 64 participants 37 participants
0.223  (0.3343) 0.274  (0.4448)
Day 1 Week 29 Number Analyzed 61 participants 38 participants
0.268  (0.3357) 0.211  (0.3653)
Day 1 Week 33 Number Analyzed 62 participants 38 participants
0.431  (0.5455) 0.183  (0.3503)
Day 1 Week 37 Number Analyzed 61 participants 38 participants
0.410  (0.4635) 0.210  (0.3325)
17.Secondary Outcome
Title Plasma Concentrations of TAK-385
Hide Description [Not Specified]
Time Frame Day 1 Week 1, 2, 3, 5, 9, 13, 17, 25, 33, 37: Pre-dose; Day 1 Week 5, 13: 2 hrs Post-dose; Day 4 Week 1: Pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population where TAK-385 assessments were available. Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Overall Number of Participants Analyzed 65
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Day 1 Week 1: Predose Number Analyzed 65 participants
0.1  (0.84)
Day 1 Week 2: Predose Number Analyzed 64 participants
11.9  (19.69)
Day 1 Week 3: Predose Number Analyzed 64 participants
10.4  (10.16)
Day 1 Week 5: Predose Number Analyzed 65 participants
9.3  (12.52)
Day 1 Week 5: 2 hrs post-dose Number Analyzed 62 participants
36.4  (38.14)
Day 1 Week 9: Predose Number Analyzed 63 participants
11.4  (18.48)
Day 1 Week 13: Predose Number Analyzed 61 participants
8.2  (6.25)
Day 1 Week 13: 2 hrs post-dose Number Analyzed 61 participants
35.8  (37.33)
Day 1 Week 17: Predose Number Analyzed 61 participants
8.7  (7.44)
Day 1 Week 25: Predose Number Analyzed 60 participants
9.5  (7.78)
Day 1 Week 29: Predose Number Analyzed 60 participants
0.3  (0.38)
Day 1 Week 33: Predose Number Analyzed 62 participants
0.1  (0.10)
Day 1 Week 37: Predose Number Analyzed 59 participants
0.1  (0.05)
Day 4 Week 1: Predose Number Analyzed 59 participants
10.5  (16.35)
18.Secondary Outcome
Title Serum Luteinizing Hormone (LH) Level
Hide Description [Not Specified]
Time Frame Baseline, Day 1 of Weeks 2, 3, 5, 9, 13, 17, 21, 25, 29, and 37
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Hide Analysis Population Description
Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Mean (Standard Deviation)
Unit of Measure: milli-international units per milliliter
Baseline Number Analyzed 65 participants 38 participants
5.838  (5.0647) 6.943  (7.6683)
Day 1 Week 2 Number Analyzed 64 participants 37 participants
0.388  (0.4167) 0.539  (0.7122)
Day 1 Week 3 Number Analyzed 65 participants 37 participants
0.223  (0.3820) 0.362  (0.5648)
Day 1 Week 5 Number Analyzed 64 participants 37 participants
0.178  (0.2547) 0.252  (0.3280)
Day 1 Week 9 Number Analyzed 64 participants 36 participants
0.198  (0.4677) 0.333  (0.5649)
Day 1 Week 13 Number Analyzed 64 participants 38 participants
0.180  (0.3979) 0.265  (0.5073)
Day 1 Week 17 Number Analyzed 64 participants 37 participants
0.184  (0.3690) 0.283  (0.5461)
Day 1 Week 21 Number Analyzed 63 participants 37 participants
0.199  (0.4670) 0.294  (0.5523)
Day 1 Week 25 Number Analyzed 64 participants 37 participants
0.325  (0.7243) 0.342  (0.6248)
Day 1 Week 29 Number Analyzed 61 participants 38 participants
4.204  (3.3259) 0.464  (0.5756)
Day 1 Week 37 Number Analyzed 62 participants 38 participants
9.441  (5.6144) 1.036  (1.4907)
19.Secondary Outcome
Title Serum Follicle-Stimulating Hormone (FSH) Level
Hide Description [Not Specified]
Time Frame Baseline, Day 1 of Week 2, 5, 13, 25 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Mean (Standard Deviation)
Unit of Measure: International units per liter (IU/L)
Baseline Number Analyzed 65 participants 38 participants
11.826  (17.3909) 11.716  (14.7839)
Day 1 Week 2 Number Analyzed 64 participants 37 participants
2.363  (2.9647) 2.519  (2.8180)
Day 1 Week 5 Number Analyzed 64 participants 37 participants
0.706  (0.9289) 0.973  (1.0951)
Day 1 Week 13 Number Analyzed 63 participants 38 participants
0.849  (1.1728) 1.108  (1.3469)
Day 1 Week 25 Number Analyzed 64 participants 38 participants
1.475  (2.1842) 1.471  (1.7437)
Day 1 Week 29 Number Analyzed 62 participants 38 participants
7.427  (5.4105) 2.032  (1.9114)
20.Secondary Outcome
Title Serum Sex Hormone-Binding Globulin (SHBG) Level
Hide Description [Not Specified]
Time Frame Baseline, Day 1 of Week 2, 5, 13, 25 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Mean (Standard Deviation)
Unit of Measure: nmol/L
Baseline Number Analyzed 65 participants 38 participants
45.528  (21.3167) 41.784  (17.8412)
Day 1 Week 2 Number Analyzed 65 participants 37 participants
49.474  (22.3975) 43.386  (15.9911)
Day 1 Week 5 Number Analyzed 65 participants 37 participants
46.797  (22.6572) 41.778  (15.7575)
Day 1 Week 13 Number Analyzed 64 participants 38 participants
46.083  (24.6853) 42.992  (19.2416)
Day 1 Week 25 Number Analyzed 64 participants 37 participants
46.258  (25.0679) 44.305  (22.2005)
Day 1 Week 29 Number Analyzed 61 participants 38 participants
43.329  (20.8000) 42.739  (21.9110)
21.Secondary Outcome
Title Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score
Hide Description AMS scale is a self-administered questionnaire used to 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between none (1) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms.
Time Frame Day 1 of Weeks 5, 13, 25, 29, 33 and 37
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Mean (Standard Deviation)
Unit of Measure: percent change
Day 1 Week 5 Number Analyzed 62 participants 38 participants
17.347  (36.1328) 19.194  (27.8573)
Day 1 Week 13 Number Analyzed 61 participants 37 participants
31.461  (41.4029) 36.117  (33.8115)
Day 1 Week 25 Number Analyzed 62 participants 38 participants
43.558  (52.4934) 48.158  (41.2365)
Day 1 Week 29 Number Analyzed 62 participants 38 participants
33.692  (44.8331) 36.950  (34.4352)
Day 1, Week 33 Number Analyzed 62 participants 38 participants
24.273  (40.0869) 40.227  (37.9232)
Day 1 Week 37 Number Analyzed 62 participants 38 participants
14.562  (30.0487) 40.535  (35.3799)
22.Secondary Outcome
Title Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score
Hide Description EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. 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'). All domain scores were calculated as an average of item scores and transformed to 0-100 score range where a high score from 0-100 indicates: A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.
Time Frame Baseline and last post-baseline value up to Week 37
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Least Squares Mean (Standard Error)
Unit of Measure: units on scale
Day 1 Week 5 Number Analyzed 62 participants 37 participants
-5.10  (1.833) -0.26  (2.370)
Day 1 Week 13 Number Analyzed 61 participants 37 participants
-4.29  (1.837) -4.33  (2.364)
Day 1 Week 25 Number Analyzed 60 participants 38 participants
-10.04  (1.842) -7.27  (2.349)
Day 1 Week 29 Number Analyzed 62 participants 38 participants
-7.11  (1.826) -8.14  (2.349)
Day 1 Week 33 Number Analyzed 62 participants 38 participants
-6.24  (1.830) -6.39  (2.349)
Day 1 Week 37 Number Analyzed 62 participants 38 participants
-7.84  (1.833) -6.61  (2.349)
23.Secondary Outcome
Title Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
Hide Description EORTC QLQ-PR25 : EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer. It Consist of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).
Time Frame Baseline and last post-baseline value up to Week 37
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description:
TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
Overall Number of Participants Analyzed 65 38
Least Squares Mean (Standard Error)
Unit of Measure: units on scale
Sexual activity: Day 1 Week 5 Number Analyzed 62 participants 37 participants
-9.78  (2.957) -9.53  (3.823)
Sexual activity: Day 1 Week 13 Number Analyzed 61 participants 37 participants
-17.43  (2.967) -11.54  (3.816)
Sexual activity: Day 1 Week 25 Number Analyzed 60 participants 38 participants
-19.32  (2.978) -12.57  (3.784)
Sexual activity: Day 1 Week 29 Number Analyzed 62 participants 38 participants
-19.06  (2.948) -5.12  (3.784)
Sexual activity: Day 1 Week 33 Number Analyzed 62 participants 38 participants
-12.40  (2.952) -9.94  (3.784)
Sexual activity: Day 1 Week 37 Number Analyzed 62 participants 38 participants
-6.60  (2.957) -6.00  (3.784)
HTRS: Day 1 Week 5 Number Analyzed 62 participants 37 participants
6.55  (1.275) 7.02  (1.651)
HTRS: Day 1 Week 13 Number Analyzed 61 participants 37 participants
10.06  (1.275) 9.98  (1.648)
HTRS: Day 1 Week 25 Number Analyzed 60 participants 38 participants
13.34  (1.276) 12.48  (1.641)
HTRS: Day 1 Week 29 Number Analyzed 62 participants 38 participants
11.53  (1.270) 10.43  (1.641)
HTRS: Day 1 Week 33 Number Analyzed 62 participants 38 participants
9.62  (1.273) 10.72  (1.641)
HTRS: Day 1 Week 37 Number Analyzed 62 participants 38 participants
8.67  (1.276) 11.31  (1.641)
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of TAK-385 or 4 weeks plus 30 days after degarelix injection, whichever is applicable.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Hide Arm/Group Description TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24. Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
All-Cause Mortality
Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   1/65 (1.54%)   3/38 (7.89%) 
Gastrointestinal disorders     
Oesophagitis ulcerative  1  0/65 (0.00%)  1/38 (2.63%) 
Injury, poisoning and procedural complications     
Road traffic accident  1  0/65 (0.00%)  1/38 (2.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Mesothelioma malignant  1  0/65 (0.00%)  1/38 (2.63%) 
Nervous system disorders     
Headache  1  1/65 (1.54%)  0/38 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  0/65 (0.00%)  1/38 (2.63%) 
Vascular disorders     
Hypertension  1  1/65 (1.54%)  0/38 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental: TAK-385 120 mg Experimental: Degarelix 80 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   56/65 (86.15%)   37/38 (97.37%) 
Eye disorders     
Cataract  1  10/65 (15.38%)  7/38 (18.42%) 
Gastrointestinal disorders     
Diarrhoea  1  12/65 (18.46%)  5/38 (13.16%) 
Constipation  1  6/65 (9.23%)  3/38 (7.89%) 
General disorders     
Fatigue  1  17/65 (26.15%)  6/38 (15.79%) 
Infections and infestations     
Nasopharyngitis  1  4/65 (6.15%)  2/38 (5.26%) 
Sinusitis  1  4/65 (6.15%)  2/38 (5.26%) 
Investigations     
Blood testosterone increased  1  2/65 (3.08%)  4/38 (10.53%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/65 (7.69%)  1/38 (2.63%) 
Nervous system disorders     
Dizziness  1  6/65 (9.23%)  2/38 (5.26%) 
Headache  1  4/65 (6.15%)  3/38 (7.89%) 
Renal and urinary disorders     
Nocturia  1  9/65 (13.85%)  5/38 (13.16%) 
Pollakiuria  1  8/65 (12.31%)  6/38 (15.79%) 
Dysuria  1  5/65 (7.69%)  6/38 (15.79%) 
Micturition urgency  1  5/65 (7.69%)  1/38 (2.63%) 
Reproductive system and breast disorders     
Erectile dysfunction  1  3/65 (4.62%)  3/38 (7.89%) 
Vascular disorders     
Hot flush  1  37/65 (56.92%)  23/38 (60.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
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 first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT02135445    
Other Study ID Numbers: C27003 Merge to Takeda
U1111-1152-9537 ( Other Identifier: World Health Organization )
2013-005002-53 ( EudraCT Number )
14/LO/1052 ( Registry Identifier: NRES )
First Submitted: May 8, 2014
First Posted: May 12, 2014
Results First Submitted: December 13, 2016
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017