To assess the efficacy of the co-administration of lanreotide Autogel 120 mg(administered via deep sub-cutaneous injections every 28 days) and pegvisomant(administered at 40 to 120 mg per week via sub-cutaneous injection given once ortwice a week)…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be the percentage of acromegalic patients with
normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment
period.
Secondary outcome
Secondary efficacy endpoints will be:
-Serum IGF-1 levels, at each assessment.
- Number and percentage of patients with normalised (age and sex adjusted)
IGF-1 levels, at each assessment.
- Acromegaly symptoms.
All these endpoints will be assessed before stopping previous treatment (visit
V1),
before the run-in period (visit V2), at visit V3, and during the co-treatment
period 4
weeks after the dose adaptation of pegvisomant (visits V5, V7, V9) and V11.
- Quality of life assessed at visits V2, V3 and V11.
Background summary
It has recently been shown that the co-administration of lanreotide (monthly) to
pegvisomant (weekly) was able to normalise IGF-1 secretion in 18/19 acromegalic
patients partially responder to somatostatin analogues (with IGF-1 levels above
normal) . If confirmed in a larger number of patients, this new regimen of
coadministration will provide substantial benefits for the patients by improving
efficacy of treatment and reducing the number of injections as well as the
cumulative dose of pegvisomant. In addition, it may provide a significant
pharmaco-economic benefit. The aim of the current study is to evaluate the
benefits for acromegalic patients of combining monthly injections of lanreotide
Autogel 120 mg and weekly doses of pegvisomant in terms of efficacy on hormonal
parameters and acromegaly symptoms and in terms of safety of the treatment.
Study objective
To assess the efficacy of the co-administration of lanreotide Autogel 120 mg
(administered via deep sub-cutaneous injections every 28 days) and pegvisomant
(administered at 40 to 120 mg per week via sub-cutaneous injection given once or
twice a week) on IGF-1 levels over 28 weeks in acromegalic patients.
The primary endpoint will be the percentage of acromegalic patients with
normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment
period.
Study design
This will be a multicentre, open, single arm, sequential study.
Intervention
Not applicable
Study burden and risks
The safety profiles of lanreotide Autogel and of pegvisomant are characterised
and both drugs are well tolerated.
Two different clinical studies have shown the effectiveness of the
co-administration of both treatments in controlling IGF-1 hypersecretion. In
addition, no new safety concern occurred with this new treatment modality,
comparatively to the safety profile of each product given separately. Overall
the total number of injections per patient will be less than the daily
treatment with pegvisomant administered alone.
Based on these data the risk / benefit ratio of the co-administration of
lanreotide and pegvisomant in the treatment of patients with acromegaly is
considered to be acceptable.
Hoofdweg Oostzijde 620
2132 MJ Hoofddorp
Nederland
Hoofdweg Oostzijde 620
2132 MJ Hoofddorp
Nederland
Listed location countries
Age
Inclusion criteria
1. Male or female aged between 18 and 75 years inclusive.
2. The patient must have had documentation supporting the diagnosis of
acromegaly, including elevated GH and/or IGF-1 levels.
3. The patient is treated with pegvisomant, because of IGF-1 level remaining
above ULN when treated with somatostatin analogue, on a daily basis for at
least 3 months and has normal (age and sex adjusted) IGF-1 level, or IGF-1
level above ULN after treatment with pegvisomant 30 mg per day,
OR the patient is treated with lanreotide Autogel or octreotide LAR for at
least 6 months including the last 3 months at the highest marketed dose, and
has a serum IGF-1 level above ULN, 28 days after the last injection.
AT THE END OF THE RUN-IN PERIOD
4. The patient has a serum IGF-1 level above 1.2 x ULN, or a serum IGF-1
level between ULN and 1.2 x ULN and a serum GH nadir > 1 µg/L
(assessed by an OGTT), 28 days after the 3rd injection of lanreotide Autogel
120 mg.
5. The patient is diabetic and has a serum IGF-1 level above 1.2 x ULN, 28
days after the 3rd injection of lanreotide Autogel 120 mg.
Exclusion criteria
1. The patient has undergone pituitary surgery or radiotherapy within 6 months
prior to study entry.
2. It is anticipated that the patient will receive pituitary surgery or radiotherapy
during the study.
3. The patient has a history of hypersensitivity to lanreotide or pegvisomant or
drugs with a similar chemical structure.
4.The patient has already been treated with a somatostatin analogue associated
with a GH antagonist.
5. The patient has received a dopamine agonist within 6 weeks prior to study
entry.
6.The patient has abnormal hepatic function at study entry (defined as AST,
ALT, GGT, AP, PT or total bilirubin above 2 x ULN).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-000297-72-NL |
| CCMO | NL13599.078.06 |