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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Prostate Cancer; Advanced Prostate Cancer; Locally Advanced Prostate Cancer
• Intervention / Treatment: Drug: Triptorelin pamoate (embonate) salt

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triptorelin pamoate 22.5 mg 6-month formulation; All enrolled participants will receive one intramuscular (i.m.) injection of containing 22.5 mg 6-month formulation triptorelin pamoate on Day 1.	Drug: Triptorelin pamoate (embonate) salt; Triptorelin pamoate 22.5 mg (6-month formulation), i.m. injection, single dose on Day 1.; Other Names: Dipherelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants achieving castrate levels of serum testosterone (<50 ng/dL or 1.735 nmol/L)	Day 29
Percentage of participants maintaining the castrate levels	From Week 8 to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent adverse event (TEAEs) (including local tolerability)		From baseline up to Week 24
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
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
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
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
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
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
PK of Triptorelin: Maximum Observed Plasma (peak) Drug Concentration (Cmax)	Cmax will be recorded from the PK blood samples collected.	Up to 24 weeks
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
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
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
PD of Testosterone: Time to Maximum Observed Drug Concentration (Tmax)	Tmax will be recorded from the PD blood samples collected.	Up to 24 weeks
PD of Testosterone: Time to Castration(Tcast)	Tcast will be recorded from the PD blood samples collected.	Up to 24 weeks
Sparse plasma concentrations of triptorelin		At pre-dose and at Week 4, 8, 12, 16, 20 and 24
Sparse serum concentrations of testosterone		At pre-dose and at Week 4, 8, 12, 16, 20 and 24

Collaborators and Investigators

• Sponsor: Ipsen
• Investigators: Study Director: Ipsen Medical, Director, Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate
• Other Study ID Numbers: D-CN-52014-237; CTR20221796 (Registry Identifier: ChinaDrugTrial.org)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan 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.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No