Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03014297
Status:
TERMINATED
Last Update Posted:
2019-08-08
First Post:
2016-12-21
Brief Title:
Fosbretabulin With Everolimus in Neuroendocrine Tumors With Progression
Sponsor:
Lowell Anthony MD
Organization:
University of Kentucky
Study Overview
Official Title:
A Phase 1 Study of Fosbretabulin in Combination With Everolimus in Neuroendocrine Tumors Grades 1-3 That Have Progressed After at Least One Prior Regimen for Metastatic Disease
Status:
TERMINATED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Part I completed Part 2 will not be done due to sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single center open label phase I study involving grade I-III gastroenteropancreatic neuroendocrine tumors consisting of a dose escalation Part A followed by an expansion cohort Part B On Part A Patients will be treated with daily oral everolimus Fosbretabulin will be administered IV either q3 weekly or q weekly based on PO CRM cohort Part B Once the investigators have established an MTD in Part A the investigators will be treating 15 more patients at that dose combination The primary and secondary objectives of the expansion cohort will be similar to Part A of the study ie to establish a safety profile of the experimental drug combination and to collect and assess efficacy data Patients will be treated with concurrent everolimus and fosbretabulin for 12 weeks
Detailed Description:
A variety of treatment options are available for NETs with carcinoid syndrome including surgical and medical therapies Most subjects require somatostatin analogs to control the symptoms of carcinoid syndrome Subjects who no longer respond to somatostatin and other liver-directed therapies who experience progression of disease and increasing symptoms have limited options including participation in a clinical trial Recently everolimus and sunitinib have been approved for the treatment of subjects with progressive locally advanced or metastatic neuroendocrine tumors Based on the preclinical data in models of NETs and the clinical activity seen in NETS and other tumor types that have existing tumor vascculature this study will examine the effectiveness of fosbretabulin given in combination with everolimus in subjects with GI-NETs and PNETsThe vasoconstrictive effect of fosbretabulin is potent though short-lived 4-8 hours with no cumulative adverse effect Everolimus inhibits angiogenesis slows tumor growth and has a prolonged half-life 30 hours Combining these two agents with distinctly different mechanisms of action may improve tumor control without additional toxicities and has the potential of reducing drug resistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None