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

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Brief Title

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

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)

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.
    



Study Type

Expanded Access




Condition

Acromegaly

Intervention

Pasireotide long acting release formulation


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug





Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01995734

Organization ID

CSOM230CUS33


Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals


Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals


Verification Date

December 2015