Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma
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|ClinicalTrials.gov Identifier: NCT00813592|
Recruitment Status : Terminated (Original PI left and company withdrew support.)
First Posted : December 23, 2008
Results First Posted : May 12, 2014
Last Update Posted : June 11, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: SOM230B||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
|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
- Objective Response Rate (ORR) of SOM230 Monotherapy in Meningioma [ Time Frame: November 2011 ]Measured the percentage of participants achieving a complete response or partial response as opposed to those participants with progressive disease or stable disease.
- To Determine the Duration of Response to SOM230 [ Time Frame: November 2011 ]
- To Establish the 6-month Progression-free Survival Rate [ Time Frame: November 2011 ]
- To Establish the Median PFS and Overall Survival (OS) [ Time Frame: November 2011 ]
- To Determine the Clinical Benefit Rate (CR + PR + Stable Disease) of SOM230 [ Time Frame: November 2011 ]
- To Characterize the Safety and Tolerability of SOM230 [ Time Frame: Monthly from study entry until subject taken off study, average 28 months ]Number of participants to experience adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813592
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Randy Jensen, MD||University of Utah|