Octreotide LAR in the Induction of Immunologic Response in NENs Patients (CSMS99)
|ClinicalTrials.gov Identifier: NCT04129255|
Recruitment Status : Active, not recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Octreotide Acetate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||IMMUNeOCT Study: Octreotide LAR in the Induction of Immunologic Response in Patient With Neuroendocrine Tumors: an Interventional Pharmacological Study|
|Actual Study Start Date :||June 28, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
OCTREOTIDE LONG-ACTING RELEASE (OCT LAR)
OCT LAR is already registered By FDA for USA, by EMA for Europe and , also, by AIFA for Italy.
Drug: Octreotide Acetate
administration every 28 days
Other Name: Somatostatin analog
- Exploring the changes in immune-regulatory cells induced by OCT LAR [ Time Frame: 6 months ]The primary objective of the project is to evaluate changes in immune-regulatory cells induced by OCT LAR from baseline to month 6. Therefore, we will observe the impact of OCTREOTIDE LAR on the immune response by studying T-Reg and MDSC and the immunoregulatory cell population in peripheral blood of patients with neuroendocrine tumors G1 / G2 treated with OCT LAR.
- Outcome [ Time Frame: 3 months (PFS - ORR) ]
Objective response rate according to RECIST.
Progression-free survival (PFS), defined as the time (days) from start date of octreotide to date of first documented disease progression or death due to any cause, if death occurs before progression is documented.
Progression-free survival as the time (days) from start date of OCT to date of first PD or death due to any cause; Safety :number of patients presenting AE during treatment and observation period (CTCAE v.4)
- safety assessment [ Time Frame: 1 month (safety) ]Safety profile according to CTCAE criteria
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129255
|Istitute Nazionale Tumori - Fondazione G. Pascale|
|Principal Investigator:||Salvatore Tafuto, MD||NCI Naples|