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Pasireotide LAR followed by Pasireotide LAR+ Everolimus

Phase 1

Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System | Small molecule | Oncology |Novartis AG|Last Updated: Dec 21, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Pasireotide LAR followed by Pasireotide LAR+ Everolimus · 1 trial · 1 indication

Phase 1 1
NCT01263353Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETsGastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
COMPLETED36 Analytics
PHASE1COMPLETED
Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
NCT0126335336
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Study Endpoints

Primary Endpoints

Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET
3 months

Secondary Endpoints

Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET
15 months
To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy
15 months
To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy
12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Functional tumors, pre-treatedEXPERIMENTAL -
Functional tumors, treatment naïveEXPERIMENTAL -
Nonfunctional tumors, pretreated 1EXPERIMENTAL -
Nonfunctional tumors, pretreated 2EXPERIMENTAL -
Nonfunctional tumors, treatment-naïve 1EXPERIMENTAL -
Nonfunctional tumors, treatment-naïve 2EXPERIMENTAL -

Interventions

NameTypeDescription
Pasireotide LAR followed by Pasireotide LAR + EverolimusDRUG -
Everolimus followed by Pasireotide LAR + EverolimusDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor * Progressive disease within last 12 months (only patients with nonfunctional tumors) * Documented liver metastasis * Measurable disease per RECIST determined by multiphase MRI o...

Countries:Germany
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