Study of Ticilimumab in Patients With Metastatic Colorectal Cancer Whose Disease Had Progressed After Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

single arm

Group Type EXPERIMENTAL

CP-675,206

Intervention Type DRUG

15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity.

Interventions

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CP-675,206

15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity.

Intervention Type DRUG

Other Intervention Names

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ticilimumab, tremelimumab

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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