Clinical trial NCT00376064: Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly
Official title: A Multicenter, Single Arm, Proof of Concept Study to Investigate the Efficacy of an 8 Month Combination Therapy of Octreotide and Cabergoline in Acromegalic Patients Only Partially Responsive to Somatostatin Analog Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acromegaly
Keywords: Growth hormone (GH)
IGF-1
Acromegaly
Pituitary adenoma
Brain tumor
Brain cancer
Octreotide acetate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy of a combination treatment with octreotide acetate and cabergoline in acromegalic patients that are only partially responsive to a somatostatin analog monotherapy


Eligibility criteria: Inclusion criteria:

* Male and female patients (\> 18 years) with prior surgery of micro- or macroadenoma of the pituitary.
* At least 6 months chronic treatment with 30mg octreotide (long acting release).
* Partial responsiveness, which is defined as follows: at any one point within the 6 months monotherapy with 30mg/month octreotide (long acting release) the patient must have experienced a decrease in GH and IGF-1 of at least 25% as compared to pre-monotherapy values (= baseline). Note: For efficacy analysis GH- and IGF-1-values measured in the central laboratory at visit 1 (=study baseline) will be used.
* Lack of suppression of GH nadir to \< 1.0 µg/L, after oral administration of 75 g of glucose (OGTT) and IGF-I levels at least 10% above the normal value ± 2 SD (adjusted for age and gender; Brabant 2003) must be proven within 4 weeks prior to visit 1. However, if acromegaly symptoms are inadequately controlled as defined in the acromegaly comorbidities and symptom evaluation (as judged by the investigator), an abnormal GH or IGF-1-value as defined above is sufficient.
* Patient's written informed consent.

Exclusion criteria:

* Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass.
* Radiotherapy planned or radiotherapy for acromegaly within the last 2 years.
* Symptomatic cholelithiasis that is clinically relevant.
* Receiving treatment with dopamine agonists within the last 6 months or prior treatment with GH-receptor-antagonists.
* Patients with renal insufficiency, Raynaud-Syndrome or gastrointestinal ulcer/ bleeding cannot be included in the study or psychose in anamnesis.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)
timeFrame: 8 months
Secondary outcomes:
measure: Effect of tumor size
timeFrame: 8 months
measure: Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values
timeFrame: 8 months
measure: Control clinical of symptoms of acromegaly
timeFrame: 8 months
measure: Quality of Life assessment
timeFrame: 8 months
measure: Safety and tolerability as assessed by frequency of AEs
timeFrame: 8 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Greifswald
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Koln
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Oldenburg
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Tubingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Wurzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: