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An ACromegaly, open-label, multi-CEnter, Safety monitoring program for treating patients with SOM230 (pasireotide) LAR who have need to receive medical therapy (ACCESS)

Description

Detailed Description
Purpose and rationale: The present study is planned as an expanded treatment protocol to provide acromegalic patients for whom medical therapy is appropriate access to pasireotide LAR (long acting release) while regulatory approval for pasireotide is sought. Intervention: Pasireotide LAR 40 mg i.m. depot injection every 28 ( 2) days, administered at the investigative site follow with safety accessment including Monitoring and recording (SAE), hematology, blood chemistry (including fasting glucose), liver function parameters, coagulation parameters, HbA1c, free T4, thyroid-stimulating hormone (TSH), serum cortisol, plasma adrenocorticotropic hormone (ACTH), urinalysis, physical examination including vital signs and body weightm 12-lead ECGs , Gallbladder ultrasound. Objectives - To document the safety of pasireotide LAR in patients with acromegaly - To document the overall safety and tolerability of pasireotide LAR in patients with acromegaly Study population/Sample characteristics: It is expected that approximately 40 adult male and female patients with active acromegaly for whom medical therapy is appropriate will be enrolled. Eligible patients must have demonstrated elevated (>1.3 x ULN) circulating IGF-1 concentrations (age- and sex-adjusted) and random GH concentration >1 g/L within 28 ( 2) days prior to screening. Study Methodology: Patients will be treated until pasireotide LAR becomes commercially available and reimbursed or until 31 December 2015, whichever occurs first. Patients will be transitioned to commercial pasireotide LAR as quickly as possible (no longer than 6 months) after commercial availability.

Phase

N/A

Inclusion and Exclusion 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.

Sites

Please contact Monica Chiu to learn more about where you can participate in this trial. Please use the contact form on the right side.

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