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An Open-Label, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of Pasireotide LAR on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-functioning Pituitary Adenoma

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Trial Information

An Open-Label, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of Pasireotide LAR on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma


Inclusion Criteria:



- Non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for
the tumor

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

- Patients who require a surgical intervention for relief of any sign or symptom
associated with tumor compression

- Previous pituitary surgery

- Previous medical treatment for pituitary tumor

- Patients who have received pituitary irradiation within 10 years prior to
randomization

- Prolactin (PRL) levels > 100 ng/mL. PRL evaluation should be performed with diluted
samples to make sure to avoid the "hook effect."

- Patients presenting prolactinomas, acromegaly or Cushing's disease

- Patients with compression of the optic chiasm causing acute clinically significant
visual field defects

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with non-functioning pituitary adenomas (NFPA) who achieve tumor volume reduction of at least 20% after 24-week treatment with pasireotide LAR

Outcome Time Frame:

24 weeks

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Brazil: ANVISA (Angência Nacional Vigilãncia Sanitária)

Study ID:

CSOM230D2401

NCT ID:

NCT01283542

Start Date:

November 2012

Completion Date:

November 2014

Related Keywords:

  • Non-functioning Pituitary Adenoma
  • Non-functioning pituitary adenoma,
  • pasireotide LAR,
  • tumor volume
  • Adenoma
  • Pituitary Neoplasms

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