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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05590793
Other study ID # D-CN-52014-237
Secondary ID CTR20221796
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 17, 2022
Est. completion date October 31, 2024

Study information

Verified date May 2024
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 195
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria : - Participant is capable of giving signed informed consent - Participant must be over 18 years of age, at the time of signing the informed consent. - 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). - Has serum testosterone level >150 ng/dL (> 5.2 nmol/L). - Has expected survival time =12 months according to the investigator's assessment. - Has Eastern Cooperative Oncology Group (ECOG) performance status score =1 Exclusion Criteria : - Risk of a serious complication in the case of tumour flare - Presence of another neoplastic lesion or brain metastases. - 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 as per Pharmacovigilance Risk Assessment Committee (PRAC) recommendations. - Metastatic hormone-sensitive prostate cancer with high tumour burden. - Metastatic castration-resistant prostate cancer. - Previous surgical castration. - Previous hormone therapy (including abiraterone) for prostate cancer within 6 months prior to study start. - Previous cytotoxic chemotherapy treatment within 6 months prior to study start. - Use of finasteride or dutasteride within 2 months prior to study start - Previous hypophysectomy or adrenalectomy - 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. - Systemic or inhaled corticosteroids (topical application permitted). - 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 - Participation in another study with an investigational drug or treatment within 3 months prior to study entry or within 5 drug half-lives of the investigational drug (whichever is the longer). - Severe kidney or liver impairment (creatinine >2 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >3 x ULN). - 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. - Known hypersensitivity to triptorelin or any of its excipients, GnRH, other GnRH agonist/analogues. - Known active use of recreational drug or alcohol dependence in the opinion of the investigator.

Study Design


Intervention

Drug:
Triptorelin pamoate (embonate) salt
Triptorelin pamoate 22.5 mg (6-month formulation), i.m. injection, single dose on Day 1.

Locations

Country Name City State
China Affiliated Hospital of Hebei University Baoding
China Beijing Hospital Beijing
China Peking University First Hospital Beijing
China Peking University People's Hospital Beijing
China Hunan Cancer Hospital Changsha
China West China Hospital of Sichuan University Chengdu
China Chongqing University Cancer Hospital Chongqing
China The First Affiliated Hospital of Chongqing Medical University Chongqing
China Deyang People's Hospital Deyang
China Sun Yat-Sen University Cancer Center Guangzhou
China Guizhou Provincial People's Hospital Guiyang
China The Affiliated Hospital of Guizhou Medical University Guiyang
China The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou
China Qilu Hospital of Shandong University Jinan
China Shandong Provincial Hospital Jinan
China Nanjing Drum Tower Hospital Nanjing
China Zhongda Hospital Southeast University Nanjing
China Ningbo First Hospital Ningbo
China Fudan University Shang Hai Cancer Center Shanghai
China Shanghai Fifth People's Hospital Shanghai
China Shanghai Tongji Hospital Shanghai
China Liaoning Cancer Hospital & Institute Shenyang
China The First Hospital of China Medical University Shenyang
China Peking University Shenzhen Hospital Shenzhen
China Suining Central Hospital Suining
China The Second Affiliated Hospital of Soochow University Suzhou
China Tianjin Cancer Hospital Tianjin
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou
China The First Affiliated Hospital of Wannan Medical College Wuhu
China The Second Affiliated Hospital of Wannan Medical College Wuhu
China Wuxi People's Hospital Wuxi
China Northern Jiangsu People's Hospital Yangzhou
China Subei People's Hospital Yangzhou
China Yantai Yuhuangding Hospital Yantai
China Henan Cancer Hospital Zhengzhou
China Zigong First People's Hospital Zigong

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants achieving castrate levels of serum testosterone (<50 ng/dL or 1.735 nmol/L) Day 29
Primary Percentage of participants maintaining the castrate levels From Week 8 to Week 24
Secondary Incidence of treatment emergent adverse event (TEAEs) (including local tolerability) From baseline up to Week 24
Secondary Actual values and changes from baseline in clinical laboratory tests Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator. At Week 24
Secondary Actual values and changes from baseline in physical examination Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator. At Day 1, Week 12 and Week 24
Secondary Percentages of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be decided by the investigator. At Week 4 and Week 24
Secondary Change from baseline in vital signs measurements Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator. At each visit up to Week 24
Secondary Percent change in prostate specific antigen (PSA) from baseline (prior to injection) Percent change in PSA is defined as the absolute value of difference between the PSA values and the baseline value divided by the baseline value At Week 12 and Week 24
Secondary Pharmacokinetics (PK) of Triptorelin: Time to Maximum Observed Drug Concentration (Tmax) Tmax will be recorded from the PK blood samples collected. Up to 24 weeks
Secondary PK of Triptorelin: Maximum Observed Plasma (peak) Drug Concentration (Cmax) Cmax will be recorded from the PK blood samples collected. Up to 24 weeks
Secondary PK of Triptorelin: Area under the Plasma Concentration Time Curve From Zero to the Time 0 to the Visit on Day 169 (AUC0-169) AUC0-169 will be recorded from the PK blood samples collected. up to Day 169
Secondary PK of Triptorelin: Area under the Plasma Concentration Time Curve From Zero to the Time 0 to the Last Quantifiable Concentration (AUClast) AUClast will be recorded from the PK blood samples collected. Up to 24 weeks
Secondary Pharmacodynamics (PD) of Testosterone: Maximum Observed Plasma (peak) Drug Concentration (Cmax) Cmax will be recorded from the PD blood samples collected. Up to 24 weeks
Secondary PD of Testosterone: Time to Maximum Observed Drug Concentration (Tmax) Tmax will be recorded from the PD blood samples collected. Up to 24 weeks
Secondary PD of Testosterone: Time to Castration(Tcast) Tcast will be recorded from the PD blood samples collected. Up to 24 weeks
Secondary Sparse plasma concentrations of triptorelin At pre-dose and at Week 4, 8, 12, 16, 20 and 24
Secondary Sparse serum concentrations of testosterone At pre-dose and at Week 4, 8, 12, 16, 20 and 24
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