Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer (DKP 3M SC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01715129
First received: October 24, 2012
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: Triptorelin Pamoate 11.25mg
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Single Arm Study to Evaluate the Efficacy, Safety and Local Tolerability of a Subcutaneous 3-month Formulation of Triptorelin Pamoate (11.25 mg) in Patients With Locally Advanced or Metastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • The proportion of patients demonstrating castration [ Time Frame: Days 29 and 183 ] [ Designated as safety issue: No ]
    The proportion of patients castrated at Day 29 and proportion of patients with castration maintained at Day 183.


Secondary Outcome Measures:
  • The proportion of patients demonstrating castration [ Time Frame: Days 92 and 95 ] [ Designated as safety issue: No ]
    The proportion of patients demonstrating castration at Day 92 (before administration of the second dose)and at Day 95 (3-4 days after administration of the second dose)

  • Determination of the time to castration (Tcast) [ Time Frame: Day 1 and castration achievement. ] [ Designated as safety issue: No ]
  • Plasma triptorelin levels [ Time Frame: Baseline, Days 92 and 183 ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: January 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 11.25mg
11.25mg, SC on Day 1 and Day 92
Drug: Triptorelin Pamoate 11.25mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Participation in any other study or receipt of any investigational compound in the 30 days (or five times the elimination half life if this is longer) prior to study entry
  • Any skin or other condition that may preclude s.c. injection administration
  • Known brain or epidural metastases.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01715129

Locations
Bulgaria
Pleven, Bulgaria
Plovdiv, Bulgaria
Shumen, Bulgaria
Varna, Bulgaria
France
Suresnes, France
Latvia
Daugavpils, Latvia
Riga, Latvia
Poland
Kutno, Poland
Warsaw, Poland
Wroclaw, Poland
Romania
Bucharest, Romania
Craiova, Romania
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Medical Director, Uro-Oncology Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01715129     History of Changes
Other Study ID Numbers: 8-55-52014-200
Study First Received: October 24, 2012
Last Updated: November 28, 2013
Health Authority: France: Agence Nationale de Surveillance du Medicament (ANSM)
Latvia: State Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Agency for Medicines and Medical Devices
Bulgaria: Bulgarian Drug Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 24, 2014