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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00313794
Collaborator
(none)
49
Enrollment
11
Locations
1
Arm
25
Duration (Months)
4.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

single arm

Drug: CP-675,206
15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity.
Other Names:
  • ticilimumab, tremelimumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. To evaluate the safety and tolerability of CP-675,206 in this population. [18 mos]

    2. To identify any human anti human antibody (HAHA) response to CP-675,206 . [3 yrs]

    3. 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]

    4. To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival. [2 yrs]

    5. To obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics. [3 yrs]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Bessemer Alabama United States 35022
    2 Research Site Birmingham Alabama United States 35205
    3 Research Site Birmingham Alabama United States 35209
    4 Research Site Birmingham Alabama United States 35211
    5 Research Site Birmingham Alabama United States 35213
    6 Research Site Birmingham Alabama United States 35235
    7 Research Site San Francisco California United States 94115
    8 Research Site San Francisco California United States 94143
    9 Research Site New York New York United States 10022
    10 Research Site Levis Quebec Canada G6V 3Z1
    11 Research Site Quebec Canada G1R 2J6

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00313794
    Other Study ID Numbers:
    • A3671014
    First Posted:
    Apr 12, 2006
    Last Update Posted:
    Jun 7, 2012
    Last Verified:
    Jun 1, 2012
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Tremelimumab

    Study Results

    No Results Posted as of Jun 7, 2012