Trial Outcomes & Findings for Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate (NCT NCT05590793)

Results Overview

Blood samples were collected to determine the serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Achievement of testosterone castration was defined as serum testosterone level \<50 nanograms per deciliter (ng/dL) or 1.735 nanomoles/liter (nmol/L). Percentages are rounded off to the tenth decimal place.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

195 participants

Primary outcome timeframe

Day 29

Results posted on

2025-09-09

Participant Flow

This Phase IIIb, open-label, single arm study was conducted at 27 investigational sites in participants with locally advanced or metastatic prostate cancer.

The study consisted of a 4-week screening period, single dose study intervention administration on Day 1 and an end of study on Day 169. A subset of participants had a more extensive sampling during the study to evaluate pharmacokinetics (PK) and pharmacodynamics (PD). A total of 195 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	Triptorelin Pamoate Participants received a single dose of triptorelin pamoate 22.5 milligrams (mg) intramuscular (IM) injection on Day 1.
Overall Study STARTED	195
Overall Study COMPLETED	188
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Triptorelin Pamoate Participants received a single dose of triptorelin pamoate 22.5 milligrams (mg) intramuscular (IM) injection on Day 1.
Overall Study Withdrawal by Subject	6
Overall Study Physician Decision	1

Baseline Characteristics

Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triptorelin Pamoate n=195 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Age, Continuous	70.8 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	195 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	195 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	195 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 29

Population: The full analysis set (FAS) included all treated participants who completed the study or were a treatment failure.

Blood samples were collected to determine the serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Achievement of testosterone castration was defined as serum testosterone level \<50 nanograms per deciliter (ng/dL) or 1.735 nanomoles/liter (nmol/L). Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=188 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29	99.5 percentage of participants Interval 97.1 to 100.0

PRIMARY outcome

Timeframe: From Week 8 to Week 24

Population: The FAS included all treated participants who completed the study or were a treatment failure.

Blood samples were collected to determine the serum testosterone concentrations using a validated, specific and sensitive LC-MS/MS method. Maintenance of castration was defined as serum testosterone level \<50 ng/dL or 1.735 nmol/L.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=188 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Percentage of Participants Who Maintained the Castrate Levels From Week 8 to Week 24	100 percentage of participants Interval 98.1 to 100.0

SECONDARY outcome

Timeframe: From the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days

Population: The safety set included all participants who received the single dose of study intervention.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, or any other medically important event. TEAEs were AEs with start date on or after the date of study intervention administration and up to 24 weeks after date of first dose of treatment. Local tolerance was assessed 2 hours (+/-15 minutes) after the single injection of 6-month formulation triptorelin by examination of injection site for signs including but not limited to tenderness, erythema, swelling, hematoma, rash, pain, itching and induration.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=195 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance Any TEAEs	160 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance Any TESAEs	8 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance TEAEs of Local Tolerance	7 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 12 and 24

Population: The FAS included all treated participants who completed the study or were a treatment failure. Only participants with data collected at specified timepoints are reported.

Blood samples were collected for the measurement of plasma PSA concentrations. Percent change in PSA was defined as the absolute value of difference between the PSA values at Week 12 and Week 24 and the baseline value divided by the baseline value. Baseline was defined as the last non-missing measurement taken prior to first study intervention administration.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=187 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Percent Change From Baseline in Prostate Specific Antigen (PSA) at Weeks 12 and 24 Week 12	-90.6815 percent change Standard Deviation 10.8057
Percent Change From Baseline in Prostate Specific Antigen (PSA) at Weeks 12 and 24 Week 24	-92.1673 percent change Standard Deviation 12.2853

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169

Population: The rich PK analysis set included all participants in the rich PK/PD subset who received 1 dose of study intervention, had no major protocol deviations affecting the PK variables, and who had a sufficient number of plasma concentrations to estimate the main PK parameters (maximum observed plasma drug concentration \[Cmax\], tmax and area under the plasma concentration time curve \[AUC\]).

Blood samples were collected at specified timepoints for the assessment of tmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=12 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Time to Maximum Observed Plasma Concentration (Tmax) of Triptorelin Pamoate	2.95 hour Interval 1.93 to 11.5

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169

Population: The rich PK analysis set included all participants in the rich PK/PD subset who received 1 dose of study intervention, had no major protocol deviations affecting the PK variables, and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, tmax and AUC).

Blood samples were collected at specified timepoints for the assessment of Cmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=12 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Maximum Observed Plasma Concentration (Cmax) of Triptorelin Pamoate	44.5 ng/milliliter (mL) Standard Deviation 17.5

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169

Population: The rich PK analysis set included all participants in the rich PK/PD subset who received 1 dose of study intervention, had no major protocol deviations affecting the PK variables, and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, tmax and AUC). Only those participants with data collected at specified timepoints are reported.

Blood samples were collected at specified timepoints for the assessment of AUC0-169 of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=9 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Area Under the Plasma Concentration Time Curve From Time 0 to the Visit on Day 169 (AUC0-169) of Triptorelin Pamoate	51.7 ng*day/mL Standard Deviation 22.9

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169

Population: The rich PK analysis set included all participants in the rich PK/PD subset who received 1 dose of study intervention, had no major protocol deviations affecting the PK variables, and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, tmax and AUC).

Blood samples were collected at specified timepoints for the assessment of AUClast of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=12 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Area Under the Plasma Concentration Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Triptorelin Pamoate	46.3 ng*day/mL Standard Deviation 22.1

SECONDARY outcome

Timeframe: Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169

Population: The rich PD analysis set included all participants in the rich PK/PD subset who had a sufficient number of PD (testosterone) measurements to estimate the main PD parameters (Cmax, tmax and time to castration \[tcast\]).

Blood samples were collected at specified timepoints for the assessment of tmax of testosterone. The PD parameters were performed using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=12 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Time to Maximum Observed Plasma Concentration of Testosterone	2.00 day Interval 0.0 to 4.02

SECONDARY outcome

Timeframe: Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169

Population: The rich PD analysis set included all participants in the rich PK/PD subset who had a sufficient number of PD (testosterone) measurements to estimate the main PD parameters (Cmax, tmax and tcast).

Blood samples were collected at specified timepoints for the assessment of Cmax of testosterone. The PD parameters were performed using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=12 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Maximum Observed Plasma Concentration of Testosterone	21.9 nmol/L Standard Deviation 6.55

SECONDARY outcome

Timeframe: Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169

Population: The rich PD analysis set included all participants in the rich PK/PD subset who had a sufficient number of PD (testosterone) measurements to estimate the main PD parameters (Cmax, tmax and tcast).

Blood samples were collected at specified timepoints for the assessment of tcast of testosterone. tcast was defined as time to reach serum testosterone level \<50 ng/dL or 1.735 nmol/L. The PD parameters were performed using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=12 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Time to Castration of Testosterone	19.3 day Interval 14.5 to 25.3

SECONDARY outcome

Timeframe: Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24

Population: The population PK analysis set included all participants who received 1 dose of triptorelin and who had at least 1 triptorelin plasma concentration and no major protocol deviations affecting PK variables. Only participants with data collected at specified timepoints are reported.

Blood samples were collected at specified timepoints for the assessment of plasma concentration of triptorelin pamoate.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=190 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Plasma Concentrations of Triptorelin Pamoate Day 1	NA ng/mL Standard Deviation NA NA indicates that data was not estimable as the values were below the lower limit of quantification (LLOQ). The LLOQ value was 0.0100 ng/mL.
Plasma Concentrations of Triptorelin Pamoate Week 4	0.0743 ng/mL Standard Deviation 0.0342
Plasma Concentrations of Triptorelin Pamoate Week 8	0.1236 ng/mL Standard Deviation 0.0536
Plasma Concentrations of Triptorelin Pamoate Week 12	0.0602 ng/mL Standard Deviation 0.0551
Plasma Concentrations of Triptorelin Pamoate Week 16	0.1555 ng/mL Standard Deviation 0.0974
Plasma Concentrations of Triptorelin Pamoate Week 20	0.0607 ng/mL Standard Deviation 0.0401
Plasma Concentrations of Triptorelin Pamoate Week 24	0.0249 ng/mL Standard Deviation 0.0225

SECONDARY outcome

Timeframe: Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24

Population: The FAS included all treated participants who completed the study or were a treatment failure. Only participants with data collected at specified timepoints are reported.

Blood samples were collected at specified timepoints for the assessment of serum concentration of testosterone.

Outcome measures

Outcome measures
Measure	Triptorelin Pamoate n=188 Participants Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Serum Concentrations of Testosterone Week 20	0.3404 nmol/L Standard Deviation 0.1580
Serum Concentrations of Testosterone Day 1	17.0506 nmol/L Standard Deviation 7.0323
Serum Concentrations of Testosterone Week 4	0.5602 nmol/L Standard Deviation 0.2749
Serum Concentrations of Testosterone Week 8	0.3294 nmol/L Standard Deviation 0.1513
Serum Concentrations of Testosterone Week 12	0.3281 nmol/L Standard Deviation 0.1416
Serum Concentrations of Testosterone Week 16	0.3334 nmol/L Standard Deviation 0.1539
Serum Concentrations of Testosterone Week 24	0.3828 nmol/L Standard Deviation 0.1899

Adverse Events

Triptorelin Pamoate

Serious events: 8 serious events

Other events: 90 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Triptorelin Pamoate n=195 participants at risk Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Blood and lymphatic system disorders Anaemia	0.51% 1/195 • Number of events 1 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Gastrointestinal disorders Abdominal hernia obstructive	0.51% 1/195 • Number of events 1 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Gastrointestinal disorders Ileus	0.51% 1/195 • Number of events 1 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Infections and infestations Nasopharyngitis	0.51% 1/195 • Number of events 1 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.51% 1/195 • Number of events 1 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.51% 1/195 • Number of events 1 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Nervous system disorders Cerebral infarction	0.51% 1/195 • Number of events 1 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Nervous system disorders Dizziness	0.51% 1/195 • Number of events 1 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Nervous system disorders Lacunar infarction	0.51% 1/195 • Number of events 1 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Skin and subcutaneous tissue disorders Skin oedema	0.51% 1/195 • Number of events 1 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.

Other adverse events

Other adverse events
Measure	Triptorelin Pamoate n=195 participants at risk Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.
Blood and lymphatic system disorders Anaemia	8.2% 16/195 • Number of events 16 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
General disorders Pyrexia	5.6% 11/195 • Number of events 13 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Infections and infestations Upper respiratory tract infection	9.2% 18/195 • Number of events 25 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Infections and infestations Nasopharyngitis	7.7% 15/195 • Number of events 19 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Investigations Alanine aminotransferase increased	6.2% 12/195 • Number of events 14 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Investigations Aspartate aminotransferase increased	5.1% 10/195 • Number of events 11 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Respiratory, thoracic and mediastinal disorders Cough	9.2% 18/195 • Number of events 26 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Skin and subcutaneous tissue disorders Hyperhidrosis	7.7% 15/195 • Number of events 32 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Vascular disorders Hot flush	5.6% 11/195 • Number of events 11 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.
Vascular disorders Hypertension	5.1% 10/195 • Number of events 13 • TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days The safety set included all participants who received the single dose of study intervention.

Additional Information

Medical Director

Ipsen

Phone: see email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place