Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma
This is a single-arm, phase II trial of SOM230 in patients with documented recurrent or progressive intracranial meningioma who have failed conventional therapy and are not candidates for complete surgical resection of their tumors and/or radiation at the time of study entry.
At the time of the final analysis, all patients who are receiving treatment with SOM230 will complete the core phase of the study and will continue on the extension phase. During this time, additional data on response duration, PFS, and safety will be collected.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma Who Have Previously Undergone or Are Not Candidates for Additional Surgery or Radiation|
- determine objective response rate (ORR) ( [CR] plus [PR]) of SOM230 monotherapy in meningioma [ Time Frame: November 2011 ] [ Designated as safety issue: No ]
- To determine the duration of response to SOM230 [ Time Frame: November 2011 ] [ Designated as safety issue: No ]
- To establish the 6-month progression-free survival rate [ Time Frame: November 2011 ] [ Designated as safety issue: No ]
- To establish the median PFS and overall survival (OS) [ Time Frame: November 2011 ] [ Designated as safety issue: No ]
- To determine the clinical benefit rate (CR + PR + stable disease) of SOM230 [ Time Frame: November 2011 ] [ Designated as safety issue: No ]
- To characterize the safety and tolerability of SOM230 [ Time Frame: November 2011 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
|Experimental: All participants||
SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
Other Name: Pasireotide
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|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Randy Jensen, MD||University of Utah|