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

Phase 2

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: CP-675,206

• Registration Number: NCT00313794
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-04-10
• Study First Submitted QC: 2006-04-10
• Study First Posted: 2006-04-12
• Study Start: 2006-05
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Disposition First Submitted: 2009-03-20
• Disposition First Submitted QC: 2009-09-24
• Disposition First Posted: 2009-09-28
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Radiographic evidence of metastatic, progressive disease following standard therapies.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

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Exclusion Criteria

• Known brain metastases or uncontrolled pleural effusions.
• History of chronic inflammatory or autoimmune disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CP-675,206	single arm

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics.	3 yrs
To evaluate the safety and tolerability of CP-675,206 in this population.	18 mos
To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival.	2 yrs
To identify any human anti human antibody (HAHA) response to CP-675,206 .	3 yrs

Trial Locations

Locations (1)

Research Site; 🇨🇦 Quebec, Canada