The purpose of this study is to look at the effect of changing from monthly (4 weekly) injections of your usual treatment (octreotide LAR) to less frequent treatment (once every 6 or 8 weeks) with lanreotide Autogel 120 mg injections. The study…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Efficacy Endpoint(s) and Evaluation(s):
The primary efficacy endpoint will be the percentage of subjects having
maintained their injection interval schedule of six weeks or increased their
injection interval to eight weeks whilst keeping their normalised IGF 1 levels
(age and sex adjusted) at study end at Week 48.
Secondary outcome
Secondary Efficacy Endpoints And Evaluations:
• Percentage of subjects with normalised IGF 1 levels (age and sex adjusted) at
Week 24.
• Percentage of subjects having maintained an injection interval of six weeks
or increasing their injection interval to eight weeks during Phase 2 of the
study.
• Percentage of subjects who extend their injection interval to eight weeks
during Phase 2 of the study, whilst maintaining normalised IGF 1 levels at Week
48.
• Mean change from baseline in IGF 1 values (expressed as % of ULN) at the end
of the study (Week 48), overall and by injection interval.
• Treatment group (A, B or C) mean baseline IGF 1 levels (expressed as % of
ULN) in subjects who maintained normalised IGF 1 values at Week 48. Comparisons
will be made as follows: A versus B, A versus C, A versus (B+C) and B versus C.
• Mean baseline IGF 1 levels (expressed as % of ULN) in all groups (A, B and C)
versus mean baseline IGF 1 levels (expressed as % of ULN) in subjects with
uncontrolled IGF 1 levels at Week 24.
• Symptoms of acromegaly (headache, excessive perspiration, fatigue, soft
tissue swelling and arthralgia) at baseline, Weeks 24 and 48.
• Mean changes from baseline in Quality of Life scores (AcroQoL* and SF 36) at
Week 24 and Week 48. Results will be presented according to IGF 1 adjusted
levels at each time point and according to the injection interval (during Phase
2 of the study).
• Serum GH levels at baseline, Weeks 24 and 48.
• The number and percentage of subjects with GH <=2.5 ng/mL at Weeks 24 and 48.
• Subject treatment schedule preference at Weeks 24 and 48. At Week 24, the
preference will be assessed between Oct-LAR intramuscular injections every four
weeks and lanreotide Autogel 120 mg subcutaneous injections every six weeks.
At Week 48 the preference will be assessed between Oct-LAR intramuscular
injections every four weeks and lanreotide Autogel 120 mg subcutaneous either
injected every four or every six or every eight weeks (as injected during phase
2 of the study treatment).
*AcroQoL will only be assessed in countries were a validated translation is
available (currently The Netherlands, Denmark, Sweden, France, Greece, Poland,
South Korea and Brazil).
Background summary
Acromegaly is the medical condition called when your body makes too much growth
hormone (GH) from a non-cancerous (benign) tumour on the pituitary gland. The
pituitary gland is a small gland located at the base of the brain behind the
bridge of the nose. This gland produces many hormones. The tumour makes too
much (GH) in the blood and this causes an increase in another hormone called
Insulin-Like Growth Factor (IGF-1).
Somatostatin is a hormone naturally produced by the body that is responsible
for reducing the GH in the blood. There are synthetic drugs (called
somatostatin analogues) that have similar structure to natural somatostatin and
have been used for many years to treat acromegaly. Two of these somatostatin
analogues can be found in the market: lanreotide Autogel (Somatuline
Autosolution) and octreotide LAR (Sandostatin LAR®). It is well known that
these drugs reduce high GH levels in the blood and reduce the symptoms of
acromegaly.
Study objective
The purpose of this study is to look at the effect of changing from monthly (4
weekly) injections of your usual treatment (octreotide LAR) to less frequent
treatment (once every 6 or 8 weeks) with lanreotide Autogel 120 mg injections.
The study doctor will monitor the treatment safety and the changes in your
acromegaly symptoms during the whole study period. You will also be asked to
give your opinion on which treatment schedule you prefer.
Study design
A prospective, international, multi-centric, open-label study, phase III / IV
Intervention
NA
Study burden and risks
Patients will not undergo more burden or risks under this protocol compared
with thier normal standard care for the disease.
Taurusavenue 33B
Hoofddorp 2132 LS
NL
Taurusavenue 33B
Hoofddorp 2132 LS
NL
Listed location countries
Age
Inclusion criteria
1) The subject has given written informed consent prior to any study-related procedures.
2) The subject is male or female and is over 18 years of age.
3) The subject must have had documentation supporting the diagnosis of acromegaly.
4) The subject has been receiving octreotide LAR (10 or 20 mg) treatment for at least six months and is biochemically controlled. Control is defined as normal (age and sex adjusted) IGF 1 levels for two consecutive measurements (at least two months apart) preceding study entry.
5) If the subject is receiving dopamine agonist therapy, treatment should be stable for at least four months, and no change in their dopamine-agonist medication is expected during the entire study period.
Exclusion criteria
1) The subject has received radiation therapy to the pituitary gland before study entry.
2) The subject has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure.
3) The subject has received a GH receptor antagonist (pegvisomant) therapy within three months before study entry.
4) The subject has undergone treatment with any other investigational drug in the 30 days before study entry or is scheduled to receive an investigational drug, other than lanreotide 120 mg, during the course of the study.
5) The subject has received any unlicensed drug within the 30 days prior to the baseline visit or is scheduled to receive an unlicensed drug during the course of the study.
6) The subject is anticipated to require pituitary surgery or to receive radiotherapy during the study.
7) The subject is likely to require treatment during the study with drugs that are not permitted by the study protocol (i.e., cyclosporine).
8) The subject is pregnant or lactating.
9) The subject is female and at risk of pregnancy during the study and is not using an acceptable contraceptive method. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide), injectable contraception or an intra uterine device. Non childbearing potential is defined as post-menopause for at least one year, surgical sterilisation or hysterectomy at least three months before the start of the study.
10) The subject has a history of, or known current, problems with alcohol or drug abuse.
11) The subject has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an unco-operative attitude.
12) The subject has abnormal baseline findings: any medical condition(s) and/or known laboratory findings that, in the opinion of the investigator, might jeopardise the subject*s safety or decrease the chance of obtaining satisfactory data to achieve the objective(s) of the study.
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 | EUCTR2007-005838-37-NL |
| ClinicalTrials.gov | NCT00701363 |
| CCMO | NL22930.078.08 |