Ignite Creation Date:
2024-05-05 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00734305
Status:
COMPLETED
Last Update Posted:
2016-09-01
First Post:
2008-08-12
Brief Title:
Phase I Safety Study of the Drug MM-121 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment
Sponsor:
Merrimack Pharmaceuticals
Organization:
Merrimack Pharmaceuticals
Study Overview
Official Title:
A Phase I and Pharmocologic Study of MM-121 in Patients With Refractory Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2016-08
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 was a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 33 design to determine maximum tolerated doserecommended Phase 2 dose
Detailed Description:
Successive cohorts of three or more patients were treated at escalating doses until a maximum tolerated doserecommended phase 2 dose was identified The study initially explored a dosing schedule every 7-days which may have been modified to longer intervals under certain circumstances but did not expand to more than weekly When the maximum tolerated doserecommended Phase 2 dose was identified an Expansion Cohort was enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints There were 3 sites that participated
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MM-121 | None | None | None |