Phase 2
N=20
Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
Non-functioning Pituitary Adenoma
Bottom Line
View on ClinicalTrials.gov: NCT01283542 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS) — 16.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pasireotide LAR (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS) |
16.7 | — |
| SECONDARY Tumor Volume Main Phase (FAS) |
2.97; 4.31; 4.31; 3.39 | — |
| SECONDARY Tumor Volume in Extension Phase (FAS) |
3.57; 3.12; 1.70 | — |
| SECONDARY Tumor Volume Change From Baseline in Main Phase (FAS) |
1.25; 0.66; 0.23 | — |
| SECONDARY Tumor Volume Change From Baseline in Extension Phase (FAS) |
0.53; -0.14; 0.0 | — |
| SECONDARY Tumor Volume Percent Change From Baseline in Main Phase (FAS) |
36.92; 39.36; 7.98 | — |
| SECONDARY Tumor Volume Percent Change From Baseline in Extension Phase (FAS) |
14.83; -2.57; -1.59 | — |
| SECONDARY Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS) |
47.4; 41.2; 75.0 | — |
| SECONDARY Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS) |
10.5; 5.9; 16.7 | — |
| SECONDARY Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS) |
10.0; 12.5; 50.0 | — |
| SECONDARY Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS) |
10.0; 12.5; 50.0 | — |
| SECONDARY Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS) |
45.0; 75.0; 52.6; 45.0; 61.5; 58.3 | — |
| SECONDARY Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS) |
0.31; 1.11; 0.15; 0.12; 130.73; 72.59 | — |
| SECONDARY Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS) |
28.91; 23.18; 36.06; 29.90; 35.72; 32.12 | — |
| SECONDARY Mean Cortisol Hormone Levels During Main and Extension Phases (FAS) |
12.60; 16.41; 12.12; 10.09 | — |
| SECONDARY Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS) |
5.57; 5.32; 7.44; 9.95; 11.83; 12.90 | — |
| SECONDARY Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS) |
452.21; 372.72; 517.52; 382.10; 1.07; 1.13 | — |
| SECONDARY Mean TSH Hormone Levels During Main and Extension Phases (FAS) |
151.81; 149.92; 1.67; 1.70 | — |
| SECONDARY Mean Alpha Subunit Levels in Main and Extension Phases (FAS) |
242.27; 309.04; 192.11; 234.21; 286.78; 435.00 | — |
| SECONDARY Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS) |
8.3; 28.6; 12.5; 22.2; 0 | — |
Summary
This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01283542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.