Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

March 2, 2017 updated by: Novartis Pharmaceuticals

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • Novartis Investigative Site
      • Berlin, Germany
        • Novartis Investigative Site
      • Bochum, Germany
        • Novartis Investigative Site
      • Erlangen, Germany
        • Novartis Investigative Site
      • Essen, Germany
        • Novartis Investigative Site
      • Greifswald, Germany
        • Novartis Investigative Site
      • Heidelberg, Germany
        • Novartis Investigative Site
      • Koln, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigative Site
      • Marburg, Germany
        • Novartis Investigative Site
      • Muenchen, Germany
        • Novartis Investigative Site
      • Oldenburg, Germany
        • Novartis Investigative Site
      • Regensburg, Germany
        • Novartis Investigative Site
      • Tubingen, Germany
        • Novartis Investigative Site
      • Ulm, Germany
        • Novartis Investigative Site
      • Wurzburg, Germany
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMS995 + Carbegolin, Somavert + SMS995
Drug: Octreotide acetate and cabergoline/Octrotide and Somavert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of tumor size
Time Frame: 8 months
8 months
Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values
Time Frame: 8 months
8 months
Control clinical of symptoms of acromegaly
Time Frame: 8 months
8 months
Quality of Life assessment
Time Frame: 8 months
8 months
Safety and tolerability as assessed by frequency of AEs
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 13, 2006

First Submitted That Met QC Criteria

September 13, 2006

First Posted (Estimate)

September 14, 2006

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMS995BDE16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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