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

AstraZeneca49 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Neoplasms

Interventions

CP-675,206DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Research Site

Bessemer, Alabama, United States

Research Site

Birmingham, Alabama, United States

Research Site

Birmingham, Alabama, United States

Research Site

Outcomes

Primary Outcomes

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

Secondary Outcomes

To evaluate the safety and tolerability of CP-675,206 in this population.

Time frame: 18 mos

To identify any human anti human antibody (HAHA) response to CP-675,206 .

Time frame: 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

To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival.

Time frame: 2 yrs

To obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics.

Time frame: 3 yrs

Data from ClinicalTrials.gov

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