Study of Ticilimumab in Patients With Metastatic Colorectal Cancer Whose Disease Had Progressed After Treatment
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00313794
First received: April 10, 2006
Last updated: June 5, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms |
Drug: CP-675,206 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the safety and tolerability of CP-675,206 in this population. [ Time Frame: 18 mos ] [ Designated as safety issue: No ]
- To identify any human anti human antibody (HAHA) response to CP-675,206 . [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival. [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
- To obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics. [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
| Enrollment: | 49 |
| Study Start Date: | May 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
single arm
|
Drug: CP-675,206
15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity.
Other Name: ticilimumab, tremelimumab
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313794
Locations
| United States, Alabama | |
| Research Site | |
| Bessemer, Alabama, United States, 35022 | |
| Research Site | |
| Birmingham, Alabama, United States, 35205 | |
| Research Site | |
| Birmingham, Alabama, United States, 35209 | |
| Research Site | |
| Birmingham, Alabama, United States, 35211 | |
| Research Site | |
| Birmingham, Alabama, United States, 35213 | |
| Research Site | |
| Birmingham, Alabama, United States, 35235 | |
| United States, California | |
| Research Site | |
| San Francisco, California, United States, 94115 | |
| Research Site | |
| San Francisco, California, United States, 94143 | |
| United States, New York | |
| Research Site | |
| New York, New York, United States, 10022 | |
| Canada, Quebec | |
| Research Site | |
| Levis, Quebec, Canada, G6V 3Z1 | |
| Canada | |
| Research Site | |
| Quebec, Canada, G1R 2J6 | |
Sponsors and Collaborators
AstraZeneca
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00313794 History of Changes |
| Other Study ID Numbers: | A3671014 |
| Study First Received: | April 10, 2006 |
| Last Updated: | June 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013