- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00313794
Study of Ticilimumab in Patients With Metastatic Colorectal Cancer Whose Disease Had Progressed After Treatment
June 5, 2012 updated by: AstraZeneca
Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Quebec, Canada, G1R 2J6
- Research Site
-
-
Quebec
-
Levis, Quebec, Canada, G6V 3Z1
- Research Site
-
-
-
-
Alabama
-
Bessemer, Alabama, United States, 35022
- Research Site
-
Birmingham, Alabama, United States, 35209
- Research Site
-
Birmingham, Alabama, United States, 35205
- Research Site
-
Birmingham, Alabama, United States, 35235
- Research Site
-
Birmingham, Alabama, United States, 35211
- Research Site
-
Birmingham, Alabama, United States, 35213
- Research Site
-
-
California
-
San Francisco, California, United States, 94115
- Research Site
-
San Francisco, California, United States, 94143
- Research Site
-
-
New York
-
New York, New York, United States, 10022
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
single arm
|
15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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 .
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the safety and tolerability of CP-675,206 in this population.
Time Frame: 18 mos
|
18 mos
|
To identify any human anti human antibody (HAHA) response to CP-675,206 .
Time Frame: 3 yrs
|
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.
Time Frame: 3 yrs
|
3 yrs
|
To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival.
Time Frame: 2 yrs
|
2 yrs
|
To obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics.
Time Frame: 3 yrs
|
3 yrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
April 10, 2006
First Submitted That Met QC Criteria
April 10, 2006
First Posted (Estimate)
April 12, 2006
Study Record Updates
Last Update Posted (Estimate)
June 7, 2012
Last Update Submitted That Met QC Criteria
June 5, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A3671014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Neoplasms
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
NuCana plcCompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States, France, United Kingdom
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Active, not recruitingColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
-
Pawel KalinskiNational Cancer Institute (NCI)CompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States
-
The Queen Elizabeth HospitalNovartis; AmgenCompletedColorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalAustralia
-
Novartis PharmaceuticalsCompletedColorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States
-
Jeremy MeyerUniversity Hospital, Geneva; Hôpital Fribourgeois; Spital Biel, SwitzerlandNot yet recruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenoma | Colorectal Adenocarcinoma | Colorectal Polyp | Colorectal Neoplasms Malignant | Colorectal Neoplasms, Benign
-
ProgenaBiomeRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Cancer Metastatic | Colorectal Carcinoma | Colorectal Adenocarcinoma | Colorectal SarcomaUnited States
-
Bristol-Myers SquibbNovartisActive, not recruitingColorectal Cancer | Colorectal Neoplasm | Colorectal Tumors | Colorectal CarcinomaItaly, United States, Canada, Spain, Argentina, Australia, Belgium, Chile, Czechia, Germany
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Disorders | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Polyp | Colorectal Neoplasms Malignant | Colorectal Adenomatous Polyp | Colorectal Cancer Stage I | Colorectal Adenoma... and other conditionsUnited States, Italy, China, Spain, Japan
Clinical Trials on CP-675,206
-
Azienda Ospedaliera Universitaria SeneseMedImmune LLCUnknownMalignant MesotheliomaItaly
-
Jonsson Comprehensive Cancer CenterPfizerCompletedMelanoma (Skin)United States
-
Azienda Ospedaliera Universitaria SeneseUnknownMalignant MesotheliomaItaly
-
Clinica Universidad de Navarra, Universidad de...PfizerCompletedHepatocellular Carcinoma | Hepatitis C Virus Chronic InfectionSpain
-
University of Wisconsin, MadisonPfizerTerminatedProstate CancerUnited States
-
PfizerWithdrawnHuman Immunodeficiency Virus
-
AstraZenecaCompletedRefractory MelanomaUnited States, Spain, Canada, France, Italy, United Kingdom, Argentina, Australia, Germany
-
AstraZenecaTerminated
-
PfizerNo longer availableAdvanced Unresectable Melanoma
-
AstraZenecaCompletedCarcinoma, Non-small-cell LungUnited States, Canada, Korea, Republic of, United Kingdom, Czech Republic