Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer

StatusCompleted
PhasePhase 1/2
Started

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Record History

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  1. Results first posted: May 28, 2026v14 Show 8 more changesShow less
    • Primary completion date: Dec 2016 to Jan 13, 2015
    • Study completion date changed from estimate of Dec 2017 to Mar 23, 2023
    • Primary endpoints revised (2)
    • Trial status: Active, Not Recruiting to Completed
    • Start date: Oct 2004 to Oct 12, 2004
    • Interventions: EPO906, celecoxib (Drug) to Celecoxib (Drug), EPO906 (Drug)
    • Secondary endpoints: 3 to 5
    • Study arms: 1 to 11
  2. Primary completion date changed from estimate of Dec 2015 to Dec 2016
    • Enrollment target: estimated 80 to confirmed 75
    • Study completion date: Jan 2017 to Dec 2017
    v13
  3. Primary completion date: Dec 2014 to Dec 2015
    • Study completion date: Jan 2016 to Jan 2017
    v12
  4. Primary completion date: Dec 2013 to Dec 2014
    • Study completion date: Jan 2014 to Jan 2016
    v11
  5. Primary completion date: Jun 2012 to Dec 2013
    • Study completion date: Jan 2013 to Jan 2014
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Trial status: Suspended to Active, Not Recruiting
    • Primary completion date: Jan 2012 to Jun 2012
    v9
  2. Trial status: Recruiting to Suspended Sponsor's reason: Pending response in first stage/cohort of patients
    • Site details revised
    v8
  3. Primary completion date: Jan 2010 to Jan 2012
    • Study completion date: Jan 2013
    v7
  4. 3 versions Re-verified since Jul 3, 2008, no change to tracked fieldsv4-v6
  5. Primary completion date: Jan 2010
    • Secondary endpoints: 4 to 3
    • Study arms: 0 to 1
    v3
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is for people with advanced colorectal cancer. This study uses the drugs Celebrex and EPO906. EPO906 is an experimental drug that has not been approved by the FDA. EPO906 is a drug that has been shown in the laboratory to cause cancer cells to die and prevents them from growing and reproducing. Celebrex is a drug that is approved by the FDA for the treatment of arthritis and prevention of colon polyps. Colon polyps are small growths in the colon. If not surgically removed, some colon polyps can become cancerous. Some studies have shown that Celebrex may reduce the side effects of chemotherapy. Other studies have shown that it may increase the effectiveness of some chemotherapy. Celebrex is not approved by the FDA for reducing the side effects of chemotherapy or improving the effectiveness of chemotherapy. The combination of EPO906 and Celebrex in this study is experimental. The main goal of this study is to see if adding the drug Celebrex to the drug EPO906 will decrease the amount of diarrhea seen in patients that receive EPO906. The goal of the first phase of this study is to find the highest dose of EPO906 that can be given safely with Celebrex. The dose of Celebrex will remain the same for the whole study. Higher doses of EPO906 will be given to each group of patients. The increase of EPO906 will stop once more than one patient has serious side effects. The highest dose of EPO906 that can be given with Celebrex (without serious side effects) will be called the pilot dose. The goal of the second phase of this study is to find out how tumors respond to these doses of the drugs. Another purpose of this study is to see how the body processes the EPO906 and Celebrex. This study will also look at the side effects of these drugs. In this study, we will measure how long subjects live, how often tumors shrink after receiving the study drugs, and how long it takes for tumors to increase in size after receiving the study drugs. This study will also measure the levels of genes, which are the cell's blueprint, in participant's tumors. Several genes can affect how people's bodies react to the cancer drugs. Genes will also be measured in participant's blood. We want to see if these predict response to the study drugs.
Trial Details
NCT Number NCT00159484
Lead Sponsor University of Southern California
Collaborators: Novartis
Conditions
(from sponsor)		 Colon Cancer, Colorectal Cancer
Related terms Colonic Neoplasms, Colorectal Neoplasms
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov