Clinical Trial: SOM230 Ectopic ACTH-producing Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Proof of Concept and Open-label Study to Test the Efficacy and Safety of Pasireotide in Patients With Ectopic ACTH-producing Tumors

Brief Summary: The purpose of this prospective open-label phase II study, is to evaluate the efficacy of pasireotide twice daily subcutaneous injections for normalizing 24 hour urine free cortisol in patients with ectopic ACTH-producing tumors as measured by the proportion of patients achieving normal UFC at the end of the study period.

Detailed Summary:
Sponsor: Cedars-Sinai Medical Center

Current Primary Outcome: Evaluate the efficacy of pasireotide twice daily subcutaneous injections for normalizing 24 hour urine free cortisol in patients with ectopic ACTH-producing tumors [ Time Frame: 6 months ]

Effectiveness of pasireotide as measured by 24 hour urine free cortisol


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with abnormal laboratory values for urine free cortisol [ Time Frame: 6 months ]
    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by urine free cortisol
  • Number of participants with abnormal laboratory values for serum cortisol levels [ Time Frame: 6 months ]
    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by serum cortisol levels
  • Number of participants with abnormal laboratory values for salivary cortisol levels [ Time Frame: 6 months ]
    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by salivary cortisol levels
  • Number of participants with abnormal laboratory values for Hemoglobin A1C (HbA1C) [ Time Frame: 6 months ]
    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by Hemoglobin A1C (HbA1C)
  • Number of participants with abnormal laboratory values for fasting blood glucose [ Time Frame: 6 months ]
    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by fasting blood glucose
  • Number of participants with abnormal laboratory values for blood electrolytes [ Time Frame: 6 months ]
    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by blood electrolytes
  • Number of participants with abnormal laboratory values for plasma adrenocorticotropic hormone (ACTH) [ Time Frame: 6 months ]
    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by plasma adrenocorticotropic hormone (ACTH)
  • Number of participants with abnormal laboratory values for plasma beta-lipotropin [ Time Frame: 6 months ]
    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by plasma beta-lipotropin
  • Number of participants with changes in clinical signs and symptoms [ Time Frame: 6 months ]
    Number of participants with changes in clinical signs and symptoms of Cushing's disease as defined by changes in weight, body mass index, and blood pressure
  • Changes in Tumor Size [ Time Frame: From baseline at months 3 and 6 ]
    To evaluate changes in tumor size
  • Number of participants with changes in blood chemistry (safety) [ Time Frame: Baseline and 6 months ]
    Number of participants with abnormal laboratory values for blood chemistry as assessed by total proteins, amylase, lipase, total cholesterol (TC), low-density lipids (LDL)-cholesterol, m creatinine, creatinine clearance, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, albumin, alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)
  • Number of participants with changes in hematology (safety) [ Time Frame: Baseline and 6 months ]
    Number of participants with abnormal laboratory values for hematology as assessed by prothrombin time (PT), and international normalized ratio (INR)
  • Number of participants with changes in cardiac activity [ Time Frame: Baseline and 6 months ]
    Number of participants with changes in cardiac activity as measured by electrocardiogram (ECG)
  • Number of participants with changes in liver health [ Time Frame: Baseline and 6 months ]
    Number of participants with changes in liver health as determined by an abdominal ultrasound


Original Secondary Outcome: Same as current

Information By: Cedars-Sinai Medical Center

Dates:
Date Received: April 26, 2016
Date Started: December 2015
Date Completion: June 2019
Last Updated: May 19, 2016
Last Verified: May 2016