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Octreotide Depot

Phase 2

Islet Cell Carcinoma | Small molecule | Oncology |Novartis AG|Last Updated: May 10, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

Octreotide Depot · 1 trial · 4 indications

Phase 2 1
NCT00363051Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to ChemotherapyIslet Cell Carcinoma
COMPLETED160 Analytics
PHASE2COMPLETED
Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
Islet Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)

Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.

Secondary Endpoints

Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
from date of first documented confirmed response to time to progression, at least 3 months
Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
from date of first documented confirmed response to time to progression, at least 3 months
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Everolimus 10 mgEXPERIMENTALStratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Stratum 2 patients who were to receive everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot therapy. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Interventions

NameTypeDescription
Everolimus 10 mgDRUGParticipants took two 5 mg tablets of Everolimus orally with a glass of water, once daily (preferably in the morning) in a fasting state or after no more than a light, fat-free meal. Dosing was to occur at the same time each day. If vomiting occurred, the vomited dose was not to be replaced.
Octreotide DepotDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion criteria for both strata: * Advanced (unresectable or metastatic) biopsy-proven pancreatic Neuroendocrine tumor (NET) * Confirmed low-grade or intermediate-grade neuroendocrine carcinoma * Objective disease progression by Response Evaluation Criteria in Solid tumors (RECIST) criteria whil...

Countries:United StatesArgentinaAustraliaBelgiumCanadaFranceGermanyItalyNetherlandsSpainSweden
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Frequently asked questions about Octreotide Depot

What is Octreotide Depot used for in Islet Cell Carcinoma?

Octreotide Depot is being studied for use in Islet Cell Carcinoma, a type of pancreatic neuroendocrine tumor. It is an investigational small molecule in Phase 2 clinical development for this indication. The drug is being evaluated in patients with advanced pancreatic neuroendocrine cancer that has not responded to chemotherapy.

What does Octreotide Depot target?

Octreotide Depot is a small molecule being developed for oncology. It is being investigated in Islet Cell Carcinoma, a form of pancreatic neuroendocrine cancer. The specific molecular target of Octreotide Depot has not been disclosed in the available clinical trial information.

Who makes Octreotide Depot?

Octreotide Depot is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. The company is conducting clinical research on this drug for the treatment of Islet Cell Carcinoma.

What phase is Octreotide Depot in?

Octreotide Depot is in Phase 2 clinical development. It is an investigational drug being studied for Islet Cell Carcinoma, a type of pancreatic neuroendocrine tumor. The drug is not yet approved and is still undergoing clinical trials to evaluate its safety and efficacy.

What clinical trials is Octreotide Depot in?

Octreotide Depot is associated with clinical trial NCT00363051, a Phase 2 study titled 'Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy.' This completed trial enrolled 160 participants across multiple countries, including the United States, Argentina, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, and Sweden.

Is Octreotide Depot the same as Everolimus?

Octreotide Depot is not the same as Everolimus. The clinical trial NCT00363051, which evaluates Everolimus, is the trial associated with Octreotide Depot's development program. However, Octreotide Depot is a distinct drug being developed by Novartis AG for Islet Cell Carcinoma.