Skip to main content
OpenTrials
Completed

NCT Number: NCT00313794

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Lévis, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CP-675,206

Drug

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

Other names: ticilimumab, tremelimumab

Primary outcomes

  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 .

    Time frame: 18 months

Secondary outcomes

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

    Time frame: 18 mos

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

    Time frame: 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.

    Time frame: 3 yrs

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

    Time frame: 2 yrs

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

    Time frame: 3 yrs

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 12, 2006
Registry last updated
Jun 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.