Clinical trial NCT00313794: Study of Ticilimumab in Patients With Metastatic Colorectal Cancer Whose Disease Had Progressed After Treatment
Official title: Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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 .
timeFrame: 18 months
Secondary outcomes:
measure: To evaluate the safety and tolerability of CP-675,206 in this population.
timeFrame: 18 mos
measure: To identify any human anti human antibody (HAHA) response to CP-675,206 .
timeFrame: 3 yrs
measure: 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.
timeFrame: 3 yrs
measure: To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival.
timeFrame: 2 yrs
measure: To obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics.
timeFrame: 3 yrs
Other outcomes:
Locations:
city: Bessemer
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: San Francisco
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: New York
country: United States
facility: Research Site
state: New York
city: Levis
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
Study officials:
References: