Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Pat… (NCT01283542) | Clinical Trial Compass
CompletedPhase 2
Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
Brazil20 participantsStarted 2012-11-26
Plain-language summary
This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)