Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT05041127
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2021-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Trial of Cetuximab for Patients With Advanced or Metastatic Chordoma
Status:
RECRUITING
Status Verified Date:
2025-08
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 is a multicenter, single arm, phase 2 study designed to evaluate the efficacy and safety of cetuximab for the treatment of advanced (unresectable)/metastatic, chordoma. The target patient population will be any chordoma patient 18 years of age with locally unresectable disease or metastatic disease.
Detailed Description:
Primary Objective:
• To evaluate the efficacy of cetuximab in patients with advanced (unresectable) or metastatic, chordoma based on response rate according to RECIST1.1.
Secondary Objectives:
* To evaluate response rate according to Choi criteria
* To evaluate the safety and tolerability of cetuximab for chordoma patients
* To evaluate the progression-free survival (median, at 24 weeks, and 52 weeks) and to determine the overall survival (median).
* To evaluate the ratio of PFS on study compared to PFS from prior treatment
• To evaluate the efficacy of cetuximab in patients with advanced (unresectable) or metastatic, chordoma based on response rate according to RECIST1.1.
Secondary Objectives:
* To evaluate response rate according to Choi criteria
* To evaluate the safety and tolerability of cetuximab for chordoma patients
* To evaluate the progression-free survival (median, at 24 weeks, and 52 weeks) and to determine the overall survival (median).
* To evaluate the ratio of PFS on study compared to PFS from prior treatment
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: