Clinical Trial: Evaluate the Efficacy and Safety of Pasireotide LAR on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Ade

Brief Summary: This study will assess pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

  • 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 [ Time Frame: 24 weeks ]
  • Mean change of tumour volume assessed by pituitary MRI [ Time Frame: from baseline to week 4, 12 and 24 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • change in tumor volume [ Time Frame: 4, 12 and 24 weeks ]
  • the effect of pasireotide LAR in hormonal response, and relevant disease-related symptoms [ Time Frame: at screening (it will be considered as baseline) and at Weeks 4, 12 and 24. ]
  • Percent change of tumour volume assessed by pituitary MRI [ Time Frame: from baseline to week 4, 12 and 24 ]
  • Proportion of patients achieving tumour volume reduction of at least ≥ 20% [ Time Frame: after 4, 12 and 24 weeks ]


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: December 17, 2010
Date Started: November 2012
Date Completion: September 2017
Last Updated: December 30, 2016
Last Verified: December 2016