Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.

NCT01283542 | Completed Phase 2 Results

• 1 other identifier: CSOM230D2401
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

Brief Summary

This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.

Conditions

Non-functioning Pituitary Adenoma

Keywords

Non-functioning pituitary adenoma,; pasireotide LAR,; tumor volume

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)

  Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility.The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24.

  Baseline up to 24 weeks

Secondary Outcomes (19)

• Tumor Volume Main Phase (FAS)

  baseline to week 4, 12, 24

• Tumor Volume in Extension Phase (FAS)

  baseline to week 48, 72, 96

• Tumor Volume Change From Baseline in Main Phase (FAS)

  baseline to week 4, 12, 24

• Tumor Volume Change From Baseline in Extension Phase (FAS)

  baseline to week 48, 72, 96

• Tumor Volume Percent Change From Baseline in Main Phase (FAS)

  baseline to week 4, 12, 24

Study Arms (1)

Pasireotide LAR

EXPERIMENTAL

All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks

Drug: Pasireotide LAR

Interventions

Pasireotide LAR DRUG

20 and 40 mg of powder in vials and 2 mL of vehicle in ampoules (for reconstitution) administered as a depot intragluteal IM (intramuscular) injection

Pasireotide LAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for the tumor
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

You may not qualify if:

• Patients who required 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 had received pituitary irradiation within 10 years prior to randomization
• Prolactin (PRL) levels \> 100 ng/mL. PRL evaluation should have been performed with diluted samples to ensure "hook effect." was avoided
• Patients who presented prolactinomas, acromegaly or Cushing's disease
• Patients with compression of the optic chiasm causing acute clinically significant visual field defects

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

Novartis Investigative Site

Fortaleza, Ceará, 04636-000, Brazil

Location

Novartis Investigative Site

Curitiba, Paraná, 80030-110, Brazil

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Novartis Investigative Site

Joinville, Santa Catarina, 89201260, Brazil

Location

Novartis Investigative Site

Botucatu, São Paulo, 18618-970, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 04023-900, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 05403 000, Brazil

Location

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: January 26, 2011
• Study Start: November 26, 2012
• Primary Completion: September 12, 2017
• Study Completion: September 12, 2017
• Last Updated: April 26, 2019
• Results First Posted: April 26, 2019

Record last verified: 2019-04

Locations

BR (7)