Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer

NCT01715129 | Completed Phase 3 Results

• 2 other identifiers: 8-55-52014-2002012-001279-35
• Study Type: interventional
• Target: 126
• Locations: 5 countries
• Sites: 12

Brief Summary

Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when administered by subcutaneous route.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183

  Percentage of subjects castrated (i.e. with serum testosterone \<50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183

  At Day 29 and 183

Secondary Outcomes (13)

• Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose

  At Day 92

• Probability of Testosterone <50 ng/dL

  Day 29 through Day 183

• Percentage of Subjects Demonstrating Castration With Testosterone Level <50 ng/dL at Day 95

  Day 95

• Time to Achieve Castration (Tcast)

  Up to Day 36

• Plasma Triptorelin Levels (Cmin)

  At Day 92 and 183

Study Arms (1)

11.25mg

EXPERIMENTAL

11.25mg, SC on Day 1 and Day 92

Drug: Triptorelin Pamoate 11.25mg

Interventions

Triptorelin Pamoate 11.25mg DRUG

11.25mg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven locally advanced or metastatic prostate cancer who are suitable for androgen deprivation therapy
• Male aged ≥18 years old
• Screening testosterone level of \>125 ng/dL
• Life expectancy of greater than 12 months in the judgement of the Investigator
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Willing to give signed informed consent freely
• Able to adhere to the study visit schedule and other protocol requirements.

You may not qualify if:

• Prior hormonal therapy for prostate cancer
• Prior surgery or radiotherapy of prostate cancer with curative intent unless disease is verified by a rising prostate specific antigen (PSA) concentration on follow up (elevated PSA values on last two tests conducted at least a month apart) and the patient is eligible for androgen deprivation therapy
• Presence or history of any other malignancy except for non melanoma skin cancer adequately treated at least 2 years before study entry
• Painful local bone lesions or spinal lesions which may lead to compression
• History of myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, Class III/IV congestive heart failure, cerebrovascular accident, transient ischaemic attack, or limb claudication at rest, within six months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and untreated atrial or uncontrolled ventricular arrhythmias
• Any condition in opinion of the Investigator, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study, compromises the objective of the study or places the patient at unacceptable risk if he participates in the study
• Abnormal haematological, hepatic or renal functions:
• Haemoglobin \<9 g/dL, absolute neutrophil count ≤1.5 x 10\^9/L or platelets ≤100 x 10\^9/L
• Serum creatinine ≥1.5 times the upper limit of normal (ULN)
• Aspartate aminotransferase or alanine aminotransferase \>2.5 times the ULN
• Known hypersensitivity to the study treatment, to any of its excipients
• Known active use of recreational drug or alcohol dependence in the opinion of the Investigator
• Any current use or use within six months prior to start of treatment, of medications which are known to affect the metabolism and/or secretion of androgenic hormones: e.g. ketoconazole, aminoglutethimide, oestrogens, and progesterone
• Use of systemic corticosteroids (inhaled corticosteroids and topical application of corticosteroids are permitted)
• Aged ≥90 years for the main study and ≥80 years for those included in the pharmacokinetic (PK) patient population

Sponsors & Collaborators

• Ipsen: lead

Study Sites (12)

Unknown Facility

Pleven, Bulgaria

Location

Unknown Facility

Plovdiv, Bulgaria

Location

Unknown Facility

Shumen, Bulgaria

Location

Unknown Facility

Varna, Bulgaria

Location

Unknown Facility

Suresnes, France

Location

Unknown Facility

Daugavpils, Latvia

Location

Unknown Facility

Riga, Latvia

Location

Unknown Facility

Kutno, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Craiova, Romania

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Medical Director, Oncology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Medical Director, Uro-Oncology

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 26, 2012
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 9, 2019
• Results First Posted: October 28, 2015

Record last verified: 2019-11

Locations

FR (1); RO (2); PL (3); LA (2); BU (4)