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

- 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

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

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

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
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 |
Acromegaly, Pituitary diseases |
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 |