Home > Clinical Trials > Multicenter, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide LAR in Patients With Metastatic Carcinoid Tumors Whose Disease-Related Symptoms Are Inadequately Controlled by Somatostatin Analogues

Multicenter, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide LAR in Patients With Metastatic Carcinoid Tumors Whose Disease-Related Symptoms Are Inadequately Controlled by Somatostatin Analogues

The objective of this study is to compare the long-term efficacy of pasireotide LAR vs. octreotide LAR in controlling diarrhea and flushing in patients with metastatic carcinoid tumors whose disease-related symptoms are inadequately controlled by the maximum approved doses of somatostatin analogues.

Eligibility

To participate in this study, patients must be at least 18 years of age or older and must:

  • Have carcinoid tumors and symptoms (diarrhea and flushing) that are not adequately controlled by somatostatin analogues
  • Produce a negative pregnancy test at baseline (for sexually active women with child-bearing potential)
  • Give written, informed consent

Exclusion Criteria

Exclusion criteria for this study includes:

  • Patients receiving radio-labeled somatostatin analogue therapy within the six months or any cytotoxic chemotherapy or interferon therapy within the two months prior to randomization 
  • Diabetic patients on anti-diabetic medications whose fasting blood glucose is poorly controlled as indicated by HBA1C  greater than 8 percent
  • Patients with symptomatic cholelithiasis 
  • Patients with malabsorption syndrome, short bowel, or cholegenic diarrhea not controlled by specific therapeutic means

Other protocol-defined inclusion and exclusion criteria may apply.

For more information, contact the clinical research coordinator at 919-668-1861.


(REF# 7293)