Trial Outcomes & Findings for Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma (NCT NCT00813592)

NCT ID: NCT00813592

Last Updated: 2014-06-11

Results Overview

Measured the percentage of participants achieving a complete response or partial response as opposed to those participants with progressive disease or stable disease.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: November 2011
• Results posted on: 2014-06-11

Participant Flow

Participant milestones

Measure	All Participants SOM230B : 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.
Overall Study STARTED	2
Overall Study Treated	2
Overall Study Response Assessment	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

All Participants SOM230B : 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.

Overall Study Disease assessment was not completed per

2

Baseline Characteristics

Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma

Baseline characteristics by cohort

Measure	All Participants n=2 Participants SOM230B : 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: November 2011

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: November 2011

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: November 2011

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: November 2011

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Monthly from study entry until subject taken off study, average 28 months

Number of participants to experience adverse events

Outcome measures

Measure

All Participants n=2 Participants SOM230B : 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.

To Characterize the Safety and Tolerability of SOM230

2 participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=2 participants at risk SOM230B: 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.
Blood and lymphatic system disorders elevated glucose level	50.0% 1/2 • Number of events 1
Respiratory, thoracic and mediastinal disorders pneumonia	50.0% 1/2 • Number of events 1
Musculoskeletal and connective tissue disorders foot pain	50.0% 1/2 • Number of events 1

Additional Information

Randy Jensen, MD, PhD

Huntsman Cancer institute

Phone: 801-585-0255

Email: randy.jensen@hci.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place