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

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Results first posted: May 28, 2026

    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); and 5 more

    Show all 9 changes in this update
    • Notable Results first posted: May 28, 2026
    • Notable Primary completion date: Dec 2016 to Jan 13, 2015
    • Notable Study completion date changed from estimate of Dec 2017 to Mar 23, 2023
    • Notable Primary endpoints revised (2)
      Show what changed
      Once MTD is established we propose to expand the dose levelIncidence of the MTD to 62 new patients to evaluate whether the addition of Celebrex to EPO906 can reduce the incidence of gradeGrade 3-4 diarrheaDiarrhea Maximum toTolerated 6% or less. To determine the maximum tolerated doseDose (MTD) of Celebrex in combinationCombination withWith EPO906 in patients with metastatic colorectal cancer.
    • Minor Trial status: Active, Not Recruiting to Completed
    • Minor Start date: Oct 2004 to Oct 12, 2004
    • Minor Interventions: EPO906, celecoxib (Drug) to Celecoxib (Drug), EPO906 (Drug)
    • Minor Secondary endpoints: 3 to 5
      Show what changed
      ToOverall estimateSurvival theRate Toxicity time(DLTs) Molecular to progression, survival and response rateBiomarkers in patientsTumor withTissue metastaticAssociated colorectalWith cancerClinical who failed 5-FU/LV, CPT-11 and/or oxaliplatin based hemotherapy and receive Celebrex in combination with EPO906. To further assess toxicity of this regimen. To investigate whether the molecular biomarkers including protein expression changes from plasma, the expression levels of VEGF, E-cadherin, TP [...] Outcome for thisThis regimenRegimen. Progression-Free Survival Rate Overall Tumor Response Rate
    • Minor Study arms: 1 to 11

    Study Status, Study Design, Arms and Interventions, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv14

  2. Notable

    Primary completion date changed from estimate of Dec 2015 to Dec 2016

    Enrollment target: estimated 80 to confirmed 75; Completion date: Jan 2017 to Dec 2017

    Study Status, Study Designv13

  3. Notable

    Primary completion date: Dec 2014 to Dec 2015

    Completion date: Jan 2016 to Jan 2017

    Study Statusv12

  4. Notable

    Primary completion date: Dec 2013 to Dec 2014

    Completion date: Jan 2014 to Jan 2016

    Study Statusv11

  5. Notable

    Primary completion date: Jun 2012 to Dec 2013

    Completion date: Jan 2013 to Jan 2014

    Study Statusv10

Show 8 earlier versions

  1. Notable

    Trial status: Suspended to Active, Not Recruiting

    Primary completion date: Jan 2012 to Jun 2012

    Study Status, Sponsor/Collaboratorsv9

  2. Stopped

    Trial status: Recruiting to Suspended

    Sponsor's reason: Pending response in first stage/cohort of patients

    Site details revised

    Study Status, Contacts/Locationsv8

  3. Notable

    Primary completion date: Jan 2010 to Jan 2012

    Completion date: Jan 2013

    Study Identification, Study Status, Oversightv7

  4. Minor

    3 amendments

    3 re-verifications since 2008-07-03, no change to tracked fields

    v4-v6

  5. Minor

    Primary completion date: Jan 2010

    Secondary endpoints: 4 to 3; Study arms: 0 to 1

    Show what changed: Secondary endpoints
    To determine the pharmacokinetic data of EPO906 when given in combination with Celebrex.

    Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Outcome Measuresv3

  6. Minor

    Study Status

    Re-verified, no change to tracked fields

    v2

  1. Minor

    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 Colon Cancer, Colorectal Cancer
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov