Clinical trial · Interventional
Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
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
NCT01283542CI-TRIAL-00038341Passion IcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-functioning Pituitary Adenoma | Non-Functioning Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pasireotide LAR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pasireotide LAR
- description
- All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
- interventionNames
- Drug: Pasireotide LAR
Primary outcomes (1)
- measure
- Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
- timeFrame
- Baseline up to 24 weeks
- description
- 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.
Secondary outcomes (19)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.