Study of Ticilimumab in Patients With Metastatic Colorectal Cancer Whose Disease Had Progressed After Treatment
Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
1 other identifier
interventional
49
2 countries
11
Brief Summary
This study is for patients with metastatic adenocarcinoma arising from the colon or rectum who have received treatment(s) for metastatic disease with subsequent disease progression. Patients who are intolerant to treatment(s) are also included. This is a study for good performance status colorectal cancer patients who have exhausted standard therapy options.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2006
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2006
CompletedFirst Posted
Study publicly available on registry
April 12, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJune 7, 2012
June 1, 2012
2.1 years
April 10, 2006
June 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 .
18 months
Secondary Outcomes (5)
To evaluate the safety and tolerability of CP-675,206 in this population.
18 mos
To identify any human anti human antibody (HAHA) response to CP-675,206 .
3 yrs
To identify potential relationships between polymorphisms in the Cytotoxic T lymphocyte-associated antigen 4 (CTLA4), Fcgamma receptor IIa (FcgRIIa), IgG2a genes with safety and/or immune response of patients treated with CP-675,206.
3 yrs
To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival.
2 yrs
To obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics.
3 yrs
Study Arms (1)
1
EXPERIMENTALsingle arm
Interventions
15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity.
Eligibility Criteria
You may qualify if:
- Radiographic evidence of metastatic, progressive disease following standard therapies.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
You may not qualify if:
- Known brain metastases or uncontrolled pleural effusions.
- History of chronic inflammatory or autoimmune disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (11)
Research Site
Bessemer, Alabama, 35022, United States
Research Site
Birmingham, Alabama, 35205, United States
Research Site
Birmingham, Alabama, 35209, United States
Research Site
Birmingham, Alabama, 35211, United States
Research Site
Birmingham, Alabama, 35213, United States
Research Site
Birmingham, Alabama, 35235, United States
Research Site
San Francisco, California, 94115, United States
Research Site
San Francisco, California, 94143, United States
Research Site
New York, New York, 10022, United States
Research Site
Lévis, Quebec, G6V 3Z1, Canada
Research Site
Québec, Quebec, G1R 2J6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2006
First Posted
April 12, 2006
Study Start
May 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
June 7, 2012
Record last verified: 2012-06