Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin

Novartis

Status and phase: Terminated; Phase 2

Conditions: Ectopic ACTH Syndrome; Pancreatic Neoplasm; Nelson Syndrome; Pituitary Neoplasm

Treatments: Drug: pasireotide LAR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958841

2008-007348-32 (EudraCT Number)

CSOM230D2203

Details and patient eligibility

About

This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and Female Patients at least 18 years old

• Patient who have rare tumors of neuroendocrine origin, such as tumors of the:

  1. pancreas
  2. pituitary glands
  3. Nelson syndrome
  4. ectopic-ACTH secreting tumor

• Patients who have failed standard of care treatment or for whom no standard of care treatment exist

• Signed Informed Consent

Exclusion criteria

• Patients with active gallbladder disease
• Patients with any ongoing or planned anti-neoplastic or interferon therapy
• Poorly controlled diabetes mellitus
• Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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118 participants in 1 patient group

pasireotide LAR 60mg

Experimental group

Description:

Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.

Treatment:

Drug: pasireotide LAR