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An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly (ACCESS)

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ClinicalTrials.gov Identifier: NCT01995734
Expanded Access Status : Approved for marketing
First Posted : November 27, 2013
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The present study is planned as an expanded treatment protocol to provide acromegalic patients for whom medical therapy is appropriate access to pasireotide LAR while regulatory approval for pasireotide is sought.

Condition or disease Intervention/treatment
Acromegaly Drug: Pasireotide long acting release formulation

Study Design
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Study Type : Expanded Access
Official Title: An ACromegaly, Open-label, Multi-CEnter, Safety Monitoring Program for Treating Patients With SOM230 (Pasireotide) LAR Who Have Need to Receive Medical Therapy (ACCESS)

Resource links provided by the National Library of Medicine

Drug Information available for: Pasireotide

Interventions
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Intervention Details:
  • Drug: Pasireotide long acting release formulation
    Pasireotide LAR will be administered intramuscularly (i.m.) every 28 days until pasireotide becomes commercially available and reimbursed or until 31 December 2015, whichever occurs first.
    Other Name: SOM230 LAR
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with confirmed diagnosis of active acromegaly with elevated IGF-1 (>ULN) and random GH (>1 μg/L) within 30 days of screening.
  • Patients who are not controlled by pituitary surgery or who are not eligible for or refuse surgery.

  • For patients on medical treatment for acromegaly the following washout periods must be completed before screening assessments are performed:

    • Dopamine agonists (bromocriptine, cabergoline): 4 weeks
    • GH-receptor antagonists (pegvisomant): 8 weeks
    • Somatostatin analogues: no washout period required
  • Karnofsky performance status ≥ 60.

Exclusion Criteria:

  • Concomitant treatment with somatostatin analogues unless concomitant treatment was discontinued 28 days before first pasireotide LAR injection is administrated.
  • Concomitant treatment with growth hormone receptor (GHR)-antagonists or dopamine agonists unless concomitant treatment was discontinued and the washout period was completed before the screening assessments are performed.
  • Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated.
  • Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression.
  • Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks of screening.
  • Patients who have received radiotherapy of the pituitary within 4 weeks prior to screening or have not recovered from side effects of radiotherapy.
  • Patients who have a history of hypothyroidism and who are not adequately treated with stable doses of thyroid hormone replacement therapy.
  • Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix).
  • Diabetic patients whose blood glucose is poorly controlled.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995734


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01995734    
Other Study ID Numbers: CSOM230CUS33
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Acromegaly, Pituitary diseases
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Pasireotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs