Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms
Both
Colorectal Neoplasms
Trial Information
Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
Inclusion Criteria:
- Radiographic evidence of metastatic, progressive disease following standard
therapies.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Exclusion Criteria:
- Known brain metastases or uncontrolled pleural effusions.
- History of chronic inflammatory or autoimmune disease.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the best overall response rate per RECIST (BRR) in patients with metastatic adenocarcinoma of the colon or rectum treated with CP-675,206 .
Outcome Time Frame:
18 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
A3671014
NCT ID:
NCT00313794
Start Date:
May 2006
Completion Date:
June 2008
Related Keywords:
- Colorectal Neoplasms
- Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| Research Site | Alabaster, Alabama |
| Research Site | Anaheim, California |
| Research Site | Albany, New York |
