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Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

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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 SiteAlabaster, Alabama  
Research SiteAnaheim, California  
Research SiteAlbany, New York