Trial Outcomes & Findings for Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer (NCT NCT01656161)
NCT ID: NCT01656161
Last Updated: 2015-09-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
within 337 days
Results posted on
2015-09-15
Participant Flow
Participants took part in the study at 10 hospital settings in South Africa, from 03 July 2012 to 30 August 2013.
Participant milestones
| Measure |
Triptorelin Embonate 22.5 mg
Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
Received Triptorelin at Day 1
|
120
|
|
Overall Study
Received Triptorelin at Day 169
|
115
|
|
Overall Study
COMPLETED
|
113
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Triptorelin Embonate 22.5 mg
Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Triptorelin Embonate 22.5 mg
n=120 Participants
Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
|
|---|---|
|
Age, Continuous
|
72.23 years
STANDARD_DEVIATION 7.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
120 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 337 daysPopulation: Intention to treat population
Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=120 Participants
Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
|
|---|---|
|
Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)
Maintaining (Day 57 to Day 337)
|
82.61 Percentage of Participants
Interval 74.43 to 89.04
|
|
Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)
Achieving (by Day 29)
|
98.33 Percentage of Participants
Interval 94.11 to 99.8
|
SECONDARY outcome
Timeframe: on Days 1 and 169Population: Intention to treat (ITT) population with a measured value at the time analysed
Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=120 Participants
Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
|
|---|---|
|
Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169
on Day 1 (n=118)
|
0.85 percentage of participants
Interval 0.02 to 4.63
|
|
Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169
on Day 169 (n=115)
|
87.83 percentage of participants
Interval 80.42 to 93.18
|
SECONDARY outcome
Timeframe: Baseline through Day 337Population: ITT population with a measured value at each specified time point
Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=120 Participants
Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
|
|---|---|
|
Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337
at Day 85 (n=119)
|
-83.20 percentage of change in PSA levels
Standard Deviation 38.10
|
|
Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337
at Day 169 (n=117)
|
-83.48 percentage of change in PSA levels
Standard Deviation 38.29
|
|
Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337
at Day 253 (n=114)
|
-85.43 percentage of change in PSA levels
Standard Deviation 33.94
|
|
Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337
at Day 337 (n=113)
|
-82.89 percentage of change in PSA levels
Standard Deviation 40.74
|
SECONDARY outcome
Timeframe: Day 171Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=120 Participants
Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
|
|---|---|
|
Number of Participants Who Presented a Real "Acute-on-chronic" (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)
|
1 participants
|
SECONDARY outcome
Timeframe: Days 1-169Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=15 Participants
Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
|
|---|---|
|
Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)
|
224.13 day*nmol/L
Interval 175.82 to 285.72
|
SECONDARY outcome
Timeframe: Days 1-169Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=15 Participants
Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
|
|---|---|
|
Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)
|
16.52 nmol/L
Interval 12.74 to 21.41
|
SECONDARY outcome
Timeframe: Days 1-169Population: PK/PD subset of 15 participants
Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=15 Participants
Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
|
|---|---|
|
Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)
|
48 hours
95% Confidence Interval 40.02 • Interval 24.0 to 48.0
|
SECONDARY outcome
Timeframe: Days 1-169Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=15 Participants
Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
|
|---|---|
|
Testosterone PD Metrics for First Injection: Time to Castration (Tcast)
|
18.01 days
Interval 16.45 to 19.72
|
SECONDARY outcome
Timeframe: Days 1-169 and Days 169-337Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=15 Participants
Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
|
|---|---|
|
Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)
AUC(1-169)
|
61.30 days * ng/mL
Interval 53.5 to 70.25
|
|
Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)
AUC(169-337)
|
66.44 days * ng/mL
Interval 58.99 to 74.82
|
SECONDARY outcome
Timeframe: Days 1-169 and Days 169-337Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=15 Participants
Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
|
|---|---|
|
Triptorelin PK Metrics for Both Injections: Cmax
Days 1-169
|
16.77 ng/mL
Interval 13.33 to 21.09
|
|
Triptorelin PK Metrics for Both Injections: Cmax
Days 169-337
|
18.09 ng/mL
Interval 14.11 to 23.2
|
SECONDARY outcome
Timeframe: Days 1-169 and Days 169-337Population: Participants in the PK/PD subset with a measured value.
Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=12 Participants
Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
|
|---|---|
|
Triptorelin PK Metrics for Both Injections: Concentration 0 Hour
Days 1-169
|
0.04 ng/mL
Interval 0.02 to 0.09
|
|
Triptorelin PK Metrics for Both Injections: Concentration 0 Hour
Days 169-337
|
0.07 ng/mL
Interval 0.04 to 0.11
|
Adverse Events
Triptorelin Embonate 22.5 mg
Serious events: 17 serious events
Other events: 117 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triptorelin Embonate 22.5 mg
n=120 participants at risk
Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.83%
1/120
|
|
Blood and lymphatic system disorders
Anaemia
|
0.83%
1/120
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
3/120
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.83%
1/120
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.83%
1/120
|
|
Infections and infestations
Cystitis
|
0.83%
1/120
|
|
General disorders
Death
|
0.83%
1/120
|
|
Blood and lymphatic system disorders
Deep vein thrombosis
|
0.83%
1/120
|
|
Endocrine disorders
Diabetic hyperglycaemic coma
|
0.83%
1/120
|
|
Musculoskeletal and connective tissue disorders
Femoral neck fracture
|
0.83%
1/120
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.83%
1/120
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.83%
1/120
|
|
Endocrine disorders
Hyperglycaemia
|
1.7%
2/120
|
|
Immune system disorders
Hypersensitivity
|
0.83%
1/120
|
|
Infections and infestations
Meningitis streptococcal
|
0.83%
1/120
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.83%
1/120
|
|
Cardiac disorders
Myocardial infarction
|
0.83%
1/120
|
|
Cardiac disorders
Myocardial ischaemia
|
1.7%
2/120
|
|
Nervous system disorders
Paraparesis
|
0.83%
1/120
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.83%
1/120
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.83%
1/120
|
|
Reproductive system and breast disorders
Prostatitis
|
0.83%
1/120
|
|
Musculoskeletal and connective tissue disorders
Radius fracture
|
0.83%
1/120
|
Other adverse events
| Measure |
Triptorelin Embonate 22.5 mg
n=120 participants at risk
Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
9.2%
11/120
|
|
General disorders
Lethargy
|
9.2%
11/120
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
8/120
|
|
Infections and infestations
Urinary tract infection
|
10.8%
13/120
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
10/120
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
9/120
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
6/120
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
6/120
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
8.3%
10/120
|
|
Vascular disorders
Hot flush
|
71.7%
86/120
|
|
Vascular disorders
Hypertension
|
11.7%
14/120
|
Additional Information
Eija Lundstrom, Medical Director
Debiopharm International
Phone: +41 21 321 06 03
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Agreement restricts the PI from discussing or publishing trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER