A Multicenter, Randomized, Double-Blind Phase 3 Study of Ramucirumab and Best Supportive Care Versus Placebo and BSC as Second-Line Treatment in Patients with Hepatocellular Carcinoma

What is the purpose of this trial?

You may change your mind and decide to withdraw your permission for the sponsor to use health information from your medical records at any time by sending a written request to, Stacey Stein, MD, Yale Cancer Center, 333 Cedar St. FMP 116, New Haven, CT, 06520. If you withdraw your permission, your participation in the study will end. However, this withdrawal will not affect your future treatment or medical management in any way, and you will not lose any benefits to which you are otherwise entitled. The study staff will stop using your information for the trial, but information or blood samples already collected up to the time you withdrew your permission will still be used for the study to maintain its scientific integrity. Keeping your health information may be necessary to analyze the study results properly. Before you make your decision, a member of the research team will be available so that you can ask any questions you have about the research project. You can ask for any information you want. Sign the consent form only after you have had a chance to ask your questions and have received satisfactory answers. The researchers may withdraw you from participating in the research if necessary for example due to safety concerns with the treatment, non-compliance, or the sponsor terminating the study. If you decide to withdraw from this project, please notify a member of the research team before you withdraw. This notice will allow that person or the research supervisor to inform you if there are any health risks or special requirements linked to withdrawing. The researchers may withdraw you from participating in the research if necessary. You are free to choose not to participate and if you do become a subject you are free to withdraw from this study at any time during its course. If you choose not to participate or if you withdraw it will not harm your relationship with your own doctors or with Yale-New Haven hospital. The researchers may withdraw you from participating in the research if necessary.

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Participation Guidelines

Click here for detailed information about who can participate in this trial.

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Sponsor:

Eli Lilly and Company
Imclone Systems, Inc

Dates:

November 2011

Last Updated:

Study HIC#:

1108008910

Clinicaltrials.gov ID: Yale9507671