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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-675,206 | Drug | 15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity. |
|
| Measure | Description | 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 . | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bessemer | Alabama | 35022 | United States | ||
| Research Site |
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C520704 | tremelimumab |
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