A phase II, open-label, multicentre study to evaluate the pharmacodynamic profile, the efficacy and the safety of a 6-month sustained-release formulation of triptorelin in patients with prostate cancer - Not applicable

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-007055-41-LT
• Date of registration: 01/03/2007
• Prospective Registration: Yes
• Primary sponsor: Beaufour Ipsen Pharma - 24, rue Erlanger 75016 Paris FRANCE
• Public title: A phase II, open-label, multicentre study to evaluate the pharmacodynamic profile, the efficacy and the safety of a 6-month sustained-release formulation of triptorelin in patients with prostate cancer - Not applicable
• Scientific title: A phase II, open-label, multicentre study to evaluate the pharmacodynamic profile, the efficacy and the safety of a 6-month sustained-release formulation of triptorelin in patients with prostate cancer - Not applicable
• Date of first enrolment: 16/04/2007
• Target sample size: 12
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-007055-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Lithuania

Key inclusion & exclusion criteria

Inclusion criteria:
All screened patients must fulfil the following:
1) Give written (personally signed and dated) informed consent before completing any study-related procedure;
2) Be 18 years old or over;
3) The patient must have a histologically-confirmed diagnosis of prostate cancer, either locally advanced or metastatic or a biological and/or clinical relapse after a curative treatment like radical prostatectomy, external radiotherapy or curietherapy amenable to androgen deprivation therapy;
4) Have a life expectancy of at least twelve months;
5) Have WHO ECOG performance status score < ou = 2;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
A screened patient will not be included in the study if he:
1) Has undergone a surgical castration;
2) Has undergone any surgery for prostate cancer within 2 weeks of baseline;
3) Has undergone radiation therapy for prostate cancer within 2 months of baseline;
4) Has undergone hormone therapy (GnRH analogue, oestrogens or steroid anti-androgens) within 3 months of baseline (previous treatment with non-steroidal anti-androgens is permitted) or could be under the effects of any hormonal therapy;
5) Has undergone any of the following treatments for prostate cancer within 2 months of baseline: immunotherapy, chemotherapy, biological response modifiers (cytokines);
6) Was treated with any other investigational medicinal product (IMP) within the last 90 days before study entry;
7) Was treated with over-the-counter or alternative medical therapies that have an oestrogenic or anti-androgenic effect within the three months of baseline;
8) Has a risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy);
9) Has a serum testosterone level below 150 ng/dL at screening;
10) Has a history of hypersensitivity to the IMP or drugs with a similar chemical structure;
11) Has any condition that may preclude subcutaneous injection;
12) Presents with known brain metastasis or leptomeningeal involvement;
13) Presents with other serious illness or medical condition;
- Active or uncontrolled infection,
- Any medical condition that might be aggravated by treatment or which could not be controlled: patients with concurrent heart failure New York Heart Association (NYHA) class III-IV or patients with severe/unstable angina pectoris, patients with myocardial infarction within 6 months, patients with history of cerebrovascular disease, and/or poorly controlled hypertension, patients who experienced venous thrombosis within six months of baseline, or have hypercalcaemia (calcium >2.9 mmol/L);
14) Has received a diagnosis of any other cancer, without a history of stability/remission, within 5 years of screening, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin;
15) Is, in the opinion of the Investigator, unable to comply fully with the protocol and the study instructions, or presents any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. psychological, familial, sociological or geographical conditions).
16) Have inadequate blood parameters;
Granulocytes < or = 2.0x10^9/L,
Platelets < or = 100x10^9/L,
Haemoglobin < 9 g/dL,
17) Have normal hepatic function;
Bilirubin >1.5xUNL,
ASAT/ALAT >2.5xUNL (and >5xUNL if liver metastasis),
Alkaline phosphatase >2.5xUNL (and >5xUNL if liver or bone metastasis),
18) Have normal renal function;
Creatinine >1.5xUNL.




Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Locally advanced or metastatic prostate cancer
MedDRA version: 9.1 Level: PT Classification code 10060862 Term: Prostate cancer

Intervention(s)

Product Name: triptorelin microimplant
Product Code: 52014
Pharmaceutical Form: Implant
INN or Proposed INN: TRIPTORELIN
CAS Number: 57773634
Current Sponsor code: 52014
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 6-

Primary Outcome(s)

Main Objective: To evaluate the pharmacodynamic profile of a 6-month sustained-release formulation of triptorelin administered as two simultaneous subcutaneous microimplant injections (2x6 mg) by measuring serum testosterone levels.

Primary end point(s): The primary endpoint is the pharmacodynamic profile derived from testosterone serum levels. Specifically, Tlag, the time to achieve castration (testosterone levels <50 ng/dL) in days post-treatment; Texit, the time to escape from castration (testosterone levels =50 ng/dL); and Tcast the duration of castration.

Secondary Objective: •To determine the proportion of patients achieving medical castration (defined as serum testosterone level <50 ng/dL) at Day 31;
•To determine the proportion of patients maintaining medical castration on Day 181;
•To evaluate the pharmacodynamic profile/efficacy by measuring LH, FSH and PSA serum levels;
•To evaluate the pharmacokinetic profile by measuring plasma triptorelin levels;
•To assess the clinical and biological tolerance of the simultaneous subcutaneous administration of the 2x6 mg microimplant formulation;
•To document the potential testosterone flare at the time of the 1st and the 2nd triptorelin administration;
•To determine the proportion of patients medically castrated (defined as serum testosterone level <50 ng/dL) on Day 361.

Secondary ID(s)

2-55-52014-151

Not applicable