Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01620138
• Date of registration: 18/09/2011
• Prospective Registration: No
• Primary sponsor: Universidade Federal do Rio de Janeiro
• Public title: Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas
• Scientific title: Somatostatin and Dopamine Receptors Expression in Non-functioning Pituitary Adenomas and Resistant Prolactinomas: Correlation With in Vitro and in Vivo Responsiveness to Somatostatin Analogs and Dopamine Agonist
• Date of first enrolment: March 2010
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01620138
• Study type: Interventional
• Phase: Phase 2/Phase 3

Countries of recruitment

Brazil

Contacts

• Name: Mônica R. Gadelha, PhD
• Affiliation: Endocrinology Section - Hospital Universitário Clementino Fraga Filho/Federal University of Rio de Janeiro

Key inclusion & exclusion criteria

Inclusion Criteria

- Male or female patients aged 18 years or greater

- Patients with confirmed diagnosis of NFPA evidenced by: magnetic resonance imaging
(MRI) confirmation of pituitary adenoma and No pituitary tumoral hormone
hypersecretion

- Patients with no previous medical treatment

- Patients who had been submitted to surgery but not cured. Lack of cure is defined as
presence of remnant tumor on MRI at least three months after surgery (without any
possible misinterpretation of postsurgical changes)

- Patients with confirmed diagnosis of resistant prolactinoma by lack of prolactin
normalization with a tolerated cabergoline dosage during 12 weeks

- Patients who had been submitted to surgery due to resistance to cabergoline and not
cured. Lack of cure is defined as lack of serum prolactin normalization or complete
removal of tumor load

- Patients who signed the informed consent

Exclusion Criteria

- Previous pituitary radiotherapy

- High risk for transsphenoidal surgery

- Patients with symptomatic cholelithiasis

- Diabetic patients on antidiabetic medications those fasting blood glucose is poorly
controlled as evidenced by HbA1C > 8%

- Patients with abnormal coagulation (prothrombin time (PT) or partial thromboplastin
time (PTT) elevated by 30% above normal limits);

- Patients receiving anticoagulants that affect PT or PTT

- Patients who have congestive heart failure (NYHA Class III or IV), unstable angina,
sustained ventricular tachycardia, clinically significant bradycardia, advanced heart
block, history of acute MI less than one year prior to study entry or clinically
significant impairment in cardiovascular function

- Patients with risk factors for torsade de pointes, i.e. patients with a baseline
corrected QT interval (QTc) > 480 ms, hypokalemia, family history of long QT syndrome,
and concomitant medications known to prolong QT interval

- Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic
persistent hepatitis, or patients with (alanine aminotransferase) ALT/ (aspartate
aminotransferase) AST more than 2 X upper limit of normal (ULN), serum creatinine >
2.0 X ULN, serum bilirubin > 2.0 X ULN, serum albumin < 0.67 X lower limit of normal
(LLN)

- Patients with white blood cell (WBC) < 3 X 109/L; Hgb < LLN; Platelet count (PLT) <
100 X 109/L

- Patients who have any current or prior medical condition that can interfere with the
conduct of the study or the evaluation of its results in the opinion of the
investigator

- Female patients who are pregnant or lactating, or are of childbearing potential and
not practicing a medically acceptable method for birth control. Female patients must
use barrier contraception with condoms. If oral contraception is used, the patient
must have been practicing this method for at least two months prior to enrollment and
must agree to continue the oral contraceptive throughout the course of the study and
for one month after the last dose of study drug. Male patients who are sexually active
are required to use condoms during the study and for 1 month afterwards

- Patients who have a history of alcohol or drug abuse in the 6 month period prior to
receiving pasireotide



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-functioning Pituitary Adenomas

Prolactinomas

Intervention(s)

Drug: cabergoline

Drug: Pasireotide

Primary Outcome(s)

Tumor Volume Changes for NFPA and Prolactin Level Changes for Prolactinoma [Time Frame: Baseline to six months]

Secondary ID(s)

CSOM230BBR01T

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/06/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01620138