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SOM230C

Phase 2

Meningioma | Small molecule | Oncology |Novartis AG|Last Updated: Oct 27, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

SOM230C · 1 trial · 1 indication

Phase 2 1
NCT00859040Monthly SOM230C for Recurrent or Progressive MeningiomaMeningioma
COMPLETED34 Analytics
PHASE2COMPLETED
Monthly SOM230C for Recurrent or Progressive Meningioma
MeningiomaUnlock trial analytics

Study Endpoints

Primary Endpoints

6 Month Progression Free Survival
6 months

Progression is defined using Modified Macdonald Criteria , using a \>/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

Secondary Endpoints

Response Rate
5 years
Treatment-related Events
5 years
Median Progression-Free Survival
5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SOM230CEXPERIMENTALMonthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)

Interventions

NameTypeDescription
SOM230CDRUGInjection in the buttocks every 28 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * 18 years of age or older * Radiographically measurable disease on contrast-enhanced MRI or CT images * Karnofsky Performance status of 60 or greater * Life expectancy of at least 3 months * Histologically confirmed diagnosis of recurrent or progressive intracranial meningioma(...

Countries:United States
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Frequently asked questions about SOM230C

What is SOM230C used for in meningioma?

SOM230C is an investigational small molecule being studied for the treatment of recurrent or progressive meningioma. It is in Phase 2 clinical development and has been evaluated in a completed clinical trial in the United States.

Who makes SOM230C?

SOM230C is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. The company is conducting clinical research on this investigational small molecule for meningioma.

What phase is SOM230C in?

SOM230C is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities, and it is being studied for the treatment of recurrent or progressive meningioma.

What clinical trials is SOM230C in?

SOM230C has been studied in one completed Phase 2 clinical trial with the identifier NCT00859040, titled 'Monthly SOM230C for Recurrent or Progressive Meningioma.' The trial enrolled 34 adult participants in the United States and was not randomized or blinded.

Is SOM230C the same as pasireotide?

SOM230C is an alternative name for pasireotide, a small molecule developed by Novartis AG. In clinical research, it has been investigated under the name SOM230C for the treatment of recurrent or progressive meningioma.