Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

NCT00376064 | Completed Phase 4

• 1 other identifier: CSMS995BDE16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 16

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

Conditions

Acromegaly

Keywords

Growth hormone (GH); IGF-1; Acromegaly; Pituitary adenoma; Brain tumor; Brain cancer; Octreotide acetate

Outcome Measures

Primary Outcomes (1)

• Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)

  8 months

Secondary Outcomes (5)

• Effect of tumor size

  8 months

• Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values

  8 months

• Control clinical of symptoms of acromegaly

  8 months

• Quality of Life assessment

  8 months

• Safety and tolerability as assessed by frequency of AEs

  8 months

Study Arms (1)

SMS995 + Carbegolin, Somavert + SMS995

EXPERIMENTAL

Drug: Octreotide acetate and cabergoline/Octrotide and Somavert

Interventions

Octreotide acetate and cabergoline/Octrotide and Somavert DRUG

SMS995 + Carbegolin, Somavert + SMS995

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (16)

Novartis Investigative Site

Aachen, Germany

Location

Novartis Investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Bochum, Germany

Location

Novartis Investigative Site

Cologne, Germany

Location

Novartis Investigative Site

Erlangen, Germany

Location

Novartis Investigative Site

Essen, Germany

Location

Novartis Investigative Site

Greifswald, Germany

Location

Novartis Investigative Site

Heidelberg, Germany

Location

Novartis Investigative Site

Leipzig, Germany

Location

Novartis Investigative Site

Marburg, Germany

Location

Novartis Investigative Site

München, Germany

Location

Novartis Investigative Site

Oldenburg, Germany

Location

Novartis Investigative Site

Regensburg, Germany

Location

Novartis Investigative Site

Tübingen, Germany

Location

Novartis Investigative Site

Ulm, Germany

Location

Novartis Investigative Site

Würzburg, Germany

Location

MeSH Terms

Conditions

Acromegaly; Pituitary Neoplasms; Brain Neoplasms

Interventions

Octreotide; Cabergoline; pegvisomant

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 14, 2006
• Study Start: March 1, 2006
• Primary Completion: January 1, 2010
• Last Updated: March 6, 2017

Record last verified: 2011-09

Locations

DE (16)