Ignite Creation Date:
2024-05-06 @ 12:13 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01520389
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2012-01-13
Brief Title:
Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment
Sponsor:
Merrimack Pharmaceuticals
Organization:
Merrimack Pharmaceuticals
Study Overview
Official Title:
A Phase 1 and Pharmacologic Study of MM-151 in Patients With Refractory Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 33 design evaluating MM-151 at varying dose levels and frequencies and subsequently in combination with irinotecan
Detailed Description:
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 33 design exploring weekly bi-weekly and tri-weekly dosing schedules Successive MM-151 monotherapy cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified and subsequently in combination with irinotecan The study consists of three parts as follows MM-151 monotherapy dose escalation Part 1 MM-151 monotherapy expansion cohort in cetuximab-refractory colorectal cancer Part 2 MM-151 irinotecan dose escalation Part 3 It is expected that approximately 4 study sites will participate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None