Study to Evaluate a Subcutaneous Four Months Sustained-re... | NCT00415246

Studies
Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer

NCT00415246

Sponsor

Ipsen

Status

Terminated

Last Update Posted

Nov 22, 2019Actual

Enrollment

100Estimated

Phase

Phase 3

Conditions

Prostate Cancer

Interventions

Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)

Countries

Belgium
France
Latvia
Lithuania
Poland
Spain
Ukraine
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2006-001511-30	EudraCT Number

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The preliminary data do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients.

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Dec 21, 2006

First Submission Date that Met QC Criteria

Dec 21, 2006

First Posted Date

Dec 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2019

Last Update Posted Date

Nov 22, 2019Actual

Description Module

Brief Summary

To identify the proportion of patients remaining medically castrated (testosterone level < 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.		Day 240

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.		Day 120
Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL.		Day 120 and 240

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient
Patient must be 18 years old or over
Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy
Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment

Exclusion Criteria:

Patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy)
Patient who underwent a previous surgical castration
Prostate cancer therapy within 2 months of baseline visit
Patient with testosterone level below 150 ng/dL at screening

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ipsen Medical Director	Ipsen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ULB Erasme		Brussels		B-1070	Belgium
Academisch Ziekenhuis Vrije Universiteit Brussel

ID	Term
D011471	Prostatic Neoplasms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
D017329	Triptorelin Pamoate
D013812	Therapeutics

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D009479	Neuropeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D009842	Oligopeptides
D009419	Nerve Tissue Proteins
D011506	Proteins