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