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”

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

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: June 2010

Intervention(s) in this Clinical Trial

• Drug: Octreotide acetate and cabergoline/Octrotide and Somavert

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: SMS995 + Carbegolin, Somavert + SMS995

Primary Measures

• Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)
  • Time Frame: 8 months
    Safety Issue?: No

Secondary Measures

• Effect of tumor size
  • Time Frame: 8 months
    Safety Issue?: No
• Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values
  • Time Frame: 8 months
    Safety Issue?: No
• Control clinical of symptoms of acromegaly
  • Time Frame: 8 months
    Safety Issue?: No
• Quality of Life assessment
  • Time Frame: 8 months
    Safety Issue?: No
• Safety and tolerability as assessed by frequency of AEs
  • Time Frame: 8 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmeceuticals  

Overall Contact: Novartis Pharmaceuticals 800-340-6843 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00376064

Study ID Number: CSMS995BDE16

ClinicalTrials.gov Identifier: NCT00376064

Health Authority: Germany: Federal Institute for Drugs and Medical Devices