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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00313794
First received: April 10, 2006
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Colorectal Neoplasms
Drug: CP-675,206
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of CP-675,206 in this population. [ Time Frame: 18 mos ] [ Designated as safety issue: No ]
  • To identify any human anti human antibody (HAHA) response to CP-675,206 . [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival. [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
  • To obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics. [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: May 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ticilimumab, tremelimumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313794

Locations
United States, Alabama
Research Site
Bessemer, Alabama, United States, 35022
Research Site
Birmingham, Alabama, United States, 35209
Research Site
Birmingham, Alabama, United States, 35213
Research Site
Birmingham, Alabama, United States, 35211
Research Site
Birmingham, Alabama, United States, 35235
Research Site
Birmingham, Alabama, United States, 35205
United States, California
Research Site
San Francisco, California, United States, 94115
Research Site
San Francisco, California, United States, 94143
United States, New York
Research Site
New York, New York, United States, 10022
Canada, Quebec
Research Site
Levis, Quebec, Canada, G6V 3Z1
Canada
Research Site
Quebec, Canada, G1R 2J6
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00313794     History of Changes
Other Study ID Numbers: A3671014
Study First Received: April 10, 2006
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Tremelimumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014