Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 3:45 AM
Study NCT ID:
NCT05590793
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2022-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017329', 'term': 'Triptorelin Pamoate'}, {'id': 'D012492', 'term': 'Salts'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@ipsen.com', 'phone': 'see email', 'title': 'Medical Director', 'organization': 'Ipsen'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'TEAEs are reported from the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days', 'description': 'The safety set included all participants who received the single dose of study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.', 'otherNumAtRisk': 195, 'deathsNumAtRisk': 195, 'otherNumAffected': 90, 'seriousNumAtRisk': 195, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 25, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 26, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 32, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Skin oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all treated participants who completed the study or were a treatment failure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Maintained the Castrate Levels From Week 8 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 8 to Week 24', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all treated participants who completed the study or were a treatment failure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}]}]}, {'title': 'Any TESAEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs of Local Tolerance', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days', 'description': '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.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all participants who received the single dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Prostate Specific Antigen (PSA) at Weeks 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-90.6815', 'spread': '10.8057', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-92.1673', 'spread': '12.2853', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Weeks 12 and 24', 'description': '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.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Observed Plasma Concentration (Tmax) of Triptorelin Pamoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.95', 'groupId': 'OG000', 'lowerLimit': '1.93', 'upperLimit': '11.5'}]}]}], 'paramType': 'MEDIAN', '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', 'description': 'Blood samples were collected at specified timepoints for the assessment of tmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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\\]).'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Triptorelin Pamoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '17.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', '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', 'description': 'Blood samples were collected at specified timepoints for the assessment of Cmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.', 'unitOfMeasure': 'ng/milliliter (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Time Curve From Time 0 to the Visit on Day 169 (AUC0-169) of Triptorelin Pamoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '22.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', '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', 'description': '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.', 'unitOfMeasure': 'ng*day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Triptorelin Pamoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '22.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', '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', 'description': 'Blood samples were collected at specified timepoints for the assessment of AUClast of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.', 'unitOfMeasure': 'ng*day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Observed Plasma Concentration of Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169', 'description': 'Blood samples were collected at specified timepoints for the assessment of tmax of testosterone. The PD parameters were performed using non-compartmental analysis.', 'unitOfMeasure': 'day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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\\]).'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration of Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '6.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169', 'description': 'Blood samples were collected at specified timepoints for the assessment of Cmax of testosterone. The PD parameters were performed using non-compartmental analysis.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Time to Castration of Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '14.5', 'upperLimit': '25.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169', 'description': '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.', 'unitOfMeasure': 'day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Triptorelin Pamoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': '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.', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0743', 'spread': '0.0342', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1236', 'spread': '0.0536', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0602', 'spread': '0.0551', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1555', 'spread': '0.0974', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0607', 'spread': '0.0401', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0249', 'spread': '0.0225', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24', 'description': 'Blood samples were collected at specified timepoints for the assessment of plasma concentration of triptorelin pamoate.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Serum Concentrations of Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.0506', 'spread': '7.0323', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5602', 'spread': '0.2749', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3294', 'spread': '0.1513', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3281', 'spread': '0.1416', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3334', 'spread': '0.1539', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3404', 'spread': '0.1580', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3828', 'spread': '0.1899', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24', 'description': 'Blood samples were collected at specified timepoints for the assessment of serum concentration of testosterone.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 milligrams (mg) intramuscular (IM) injection on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '195'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This Phase IIIb, open-label, single arm study was conducted at 27 investigational sites in participants with locally advanced or metastatic prostate cancer.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Triptorelin Pamoate', 'description': 'Participants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.8', 'spread': '8.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '195', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '195', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety set included all participants who received the single dose of study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-18', 'size': 10863971, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-22T01:47', 'hasProtocol': True}, {'date': '2024-09-24', 'size': 5431955, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-22T01:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2022-10-14', 'resultsFirstSubmitDate': '2025-08-18', 'studyFirstSubmitQcDate': '2022-10-20', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-18', 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29', 'timeFrame': 'Day 29', 'description': '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.'}, {'measure': 'Percentage of Participants Who Maintained the Castrate Levels From Week 8 to Week 24', 'timeFrame': 'From Week 8 to Week 24', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance', 'timeFrame': 'From the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days', 'description': '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.'}, {'measure': 'Percent Change From Baseline in Prostate Specific Antigen (PSA) at Weeks 12 and 24', 'timeFrame': 'Baseline (Day 1), Weeks 12 and 24', 'description': '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.'}, {'measure': 'Time to Maximum Observed Plasma Concentration (Tmax) of Triptorelin Pamoate', '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', 'description': 'Blood samples were collected at specified timepoints for the assessment of tmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Triptorelin Pamoate', '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', 'description': 'Blood samples were collected at specified timepoints for the assessment of Cmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.'}, {'measure': 'Area Under the Plasma Concentration Time Curve From Time 0 to the Visit on Day 169 (AUC0-169) of Triptorelin Pamoate', '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', 'description': '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.'}, {'measure': 'Area Under the Plasma Concentration Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Triptorelin Pamoate', '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', 'description': 'Blood samples were collected at specified timepoints for the assessment of AUClast of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.'}, {'measure': 'Time to Maximum Observed Plasma Concentration of Testosterone', 'timeFrame': 'Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169', 'description': 'Blood samples were collected at specified timepoints for the assessment of tmax of testosterone. The PD parameters were performed using non-compartmental analysis.'}, {'measure': 'Maximum Observed Plasma Concentration of Testosterone', 'timeFrame': 'Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169', 'description': 'Blood samples were collected at specified timepoints for the assessment of Cmax of testosterone. The PD parameters were performed using non-compartmental analysis.'}, {'measure': 'Time to Castration of Testosterone', 'timeFrame': 'Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169', 'description': '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.'}, {'measure': 'Plasma Concentrations of Triptorelin Pamoate', 'timeFrame': 'Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24', 'description': 'Blood samples were collected at specified timepoints for the assessment of plasma concentration of triptorelin pamoate.'}, {'measure': 'Serum Concentrations of Testosterone', 'timeFrame': 'Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24', 'description': 'Blood samples were collected at specified timepoints for the assessment of serum concentration of testosterone.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Prostate Cancer', 'Metastatic Prostate Cancer', 'Locally Advanced Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The main aim of this study is to assess the effectiveness and safety of the 6-month formulation of triptorelin pamoate in Chinese participants with locally advanced or metastatic cancer of the prostate. Participants will receive 1 injection of triptorelin pamoate 6-month formulation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only Male is enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria :\n\n* Participant is capable of giving signed informed consent\n* Participant must be over 18 years of age, at the time of signing the informed consent.\n* Has a histologically or cytologically confirmed adenocarcinoma, locally advanced or metastatic prostate cancer. Or participant has PSA recurrence after curative treatment and be a candidate for androgen deprivation therapy (ADT).\n* Has serum testosterone level \\>150 ng/dL (\\> 5.2 nmol/L).\n* Has expected survival time ≥12 months according to the investigator's assessment.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status score ≤1\n\nExclusion Criteria :\n\n* Risk of a serious complication in the case of tumour flare\n* Presence of another neoplastic lesion or brain metastases.\n* Previous history of QT prolongation or concomitant use of medicinal products known to prolong the QT interval or with a known risk of torsades de pointes.\n* Metastatic hormone-sensitive prostate cancer with high tumour burden.\n* Metastatic castration-resistant prostate cancer.\n* Previous surgical castration.\n* Previous hormone therapy (including abiraterone) for prostate cancer within 6 months prior to study start.\n* Previous cytotoxic chemotherapy treatment within 6 months prior to study screening.\n* Use of finasteride or dutasteride within 2 months prior to study screening.\n* Previous hypophysectomy or adrenalectomy\n* Any current use or use within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and antiandrogens.\n* Current use of systemic or inhaled corticosteroids (topical application permitted).\n* Any previous use of traditional Chinese medicine or herbal products within 1 month prior to study screening or planned use during the study of products, which are known to have cytotoxic effect or affect the metabolism and/or secretion of androgenic hormones\n* Participation in another study with an investigational drug or treatment within 3 months prior to study screening or within 5 drug half-lives of the investigational drug (whichever is the longer).\n* Severe kidney or liver impairment (creatinine \\>2 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\>3 x ULN).\n* Any concomitant disorder or resulting therapy that is likely to interfere with participant compliance, the i.m. administration of the drug or with the study in the opinion of the investigator.\n* Known hypersensitivity to triptorelin or any of its excipients, GnRH, other GnRH agonist/analogues.\n* Known active use of recreational drug or alcohol dependence in the opinion of the investigator."}, 'identificationModule': {'nctId': 'NCT05590793', 'briefTitle': 'Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A Multicentre, Open-label, Single-arm Study to Investigate the Efficacy and Safety of Triptorelin Pamoate 22.5 mg 6-month Formulation in Chinese Patients With Locally Advanced or Metastatic Prostate Cancer', 'orgStudyIdInfo': {'id': 'D-CN-52014-237'}, 'secondaryIdInfos': [{'id': 'CTR20221796', 'type': 'REGISTRY', 'domain': 'ChinaDrugTrial.org'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triptorelin pamoate 22.5 mg 6-month formulation', 'description': 'All enrolled participants will receive one intramuscular (i.m.) injection of containing 22.5 mg 6-month formulation triptorelin pamoate on Day 1.', 'interventionNames': ['Drug: Triptorelin pamoate (embonate) salt']}], 'interventions': [{'name': 'Triptorelin pamoate (embonate) salt', 'type': 'DRUG', 'otherNames': ['Dipherelin'], 'description': 'Triptorelin pamoate 22.5 mg (6-month formulation), i.m. injection, single dose on Day 1.', 'armGroupLabels': ['Triptorelin pamoate 22.5 mg 6-month formulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baoding', 'country': 'China', 'facility': 'Affiliated Hospital of Hebei University', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changsha', 'country': 'China', 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Chengdu', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Chongqing University Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Deyang', 'country': 'China', 'facility': "Deyang People's Hospital", 'geoPoint': {'lat': 31.13019, 'lon': 104.38198}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Sun Yat-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guiyang', 'country': 'China', 'facility': "Guizhou Provincial People's Hospital", 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'city': 'Guiyang', 'country': 'China', 'facility': 'The Affiliated Hospital of Guizhou Medical University', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'city': 'Hangzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Jinan', 'country': 'China', 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'country': 'China', 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Nanjing', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'country': 'China', 'facility': 'Zhongda Hospital Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Ningbo', 'country': 'China', 'facility': 'Ningbo First Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Shang Hai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Fifth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Tongji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenyang', 'country': 'China', 'facility': 'Liaoning Cancer Hospital & Institute', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'country': 'China', 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenzhen', 'country': 'China', 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Suining', 'country': 'China', 'facility': 'Suining Central Hospital', 'geoPoint': {'lat': 30.50802, 'lon': 105.57332}}, {'city': 'Suzhou', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Wenzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'city': 'Wuhu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Wannan Medical College', 'geoPoint': {'lat': 31.35259, 'lon': 118.42947}}, {'city': 'Wuhu', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Wannan Medical College', 'geoPoint': {'lat': 31.35259, 'lon': 118.42947}}, {'city': 'Wuxi', 'country': 'China', 'facility': "Wuxi People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'city': 'Yangzhou', 'country': 'China', 'facility': "Northern Jiangsu People's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'city': 'Yangzhou', 'country': 'China', 'facility': "Subei People's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'city': 'Yantai', 'country': 'China', 'facility': 'Yantai Yuhuangding Hospital', 'geoPoint': {'lat': 37.47649, 'lon': 121.44081}}, {'city': 'Zhengzhou', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Zigong', 'country': 'China', 'facility': "Zigong First People's Hospital", 'geoPoint': {'lat': 29.34162, 'lon': 104.77689}}], 'overallOfficials': [{'name': 'Ipsen Medical, Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/members/ourmembers', 'timeFrame': 'Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.', 'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.\n\nAny requests should be submitted to www.vivli.org for assessment by an independent scientific review board.', 'accessCriteria': "Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}