Active not recruiting

A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (REACH-2)

I4T-MC-JVDE - ClinicalTrials.gov - NCT02435433

The purpose of this study is to evaluate the safety and efficacy of ramucirumab in participants with hepatocellular carcinoma (HCC) (liver cancer) and elevated baseline alpha-fetoprotein.
How long will I be in the trial?
Your participation in this trial could last up to 3-5 months depending on on how you and your tumor respond
Email
Active not recruiting

A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (REACH-2)

I4T-MC-JVDE - ClinicalTrials.gov - NCT02435433

The purpose of this study is to evaluate the safety and efficacy of ramucirumab in participants with hepatocellular carcinoma (HCC) (liver cancer) and elevated baseline alpha-fetoprotein.
How long will I be in the trial?
Your participation in this trial could last up to 3-5 months depending on on how you and your tumor respond
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participant must have a confirmed diagnosis of liver cancer or a diagnosis of cirrhosis and a tumor with imaging characteristics of liver cancer

Participants in the United States, European Union, Taiwan and Hong Kong must have previously taken a therapy other than sorafenib for the treatment of liver cancer

Participants in China must have previously taken sorafenib for the treatment of liver cancer

Participant must be willing to provide blood for research

Female participant must not be pregnant or breastfeeding and must also use highly effective contraceptive method during study participation, if not surgically sterile or postmenopausal

Male participant must be surgically sterile or compliant with a highly effective contraceptive method

Participants must NOT

Participant must not have undergone a prior liver transplant

Participant must not have uncontrolled hypertension, HIV, AIDS, active or uncontrolled clinically serious infection, ongoing or recent drug abuse, uncontrolled thrombotic or bleeding disorder or a bowel obstruction

Trial Summary

Conditions the trial is for

Liver Cancer

What the trial is testing?

Ramucirumab, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

292

Trial Dates

July 2015 - December 2021

Trial Phase

3

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participant must have a confirmed diagnosis of liver cancer or a diagnosis of cirrhosis and a tumor with imaging characteristics of liver cancer

Participants in the United States, European Union, Taiwan and Hong Kong must have previously taken a therapy other than sorafenib for the treatment of liver cancer

Participants in China must have previously taken sorafenib for the treatment of liver cancer

Participant must be willing to provide blood for research

Female participant must not be pregnant or breastfeeding and must also use highly effective contraceptive method during study participation, if not surgically sterile or postmenopausal

Male participant must be surgically sterile or compliant with a highly effective contraceptive method

Participants must NOT

Participant must not have undergone a prior liver transplant

Participant must not have uncontrolled hypertension, HIV, AIDS, active or uncontrolled clinically serious infection, ongoing or recent drug abuse, uncontrolled thrombotic or bleeding disorder or a bowel obstruction

Trial Summary

Conditions the trial is for

Liver Cancer

What the trial is testing?

Ramucirumab, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

292

Trial Dates

July 2015 - December 2021

Trial Phase

3

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Trial Locations

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Liver Cancer Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?