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Ramucirumab/Merestinib + Chemotherapy for Biliary Tract Cancer
Study Summary
This trial is testing ramucirumab, merestinib, or placebo in combination with cisplatin and gemcitabine to see if it can help treat people with advanced or metastatic biliary tract cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My cancer is a type of biliary tract cancer that cannot be surgically removed.I have had cancer or have another cancer besides the one being studied.I expect to undergo a major surgery during the study.I do not have severe health issues unrelated to my cancer that could risk my life.My cancer is a mix of liver and bile duct types.I have or had brain issues due to liver disease, severe fluid buildup in my abdomen, or serious liver damage.My organs are functioning well.I have not had a heart attack, stroke, or similar event in the last 6 months.I have a history of uncontrollable blood clotting disorders.I am fully active or restricted in physically strenuous activity but can do light work.My bile ducts are draining properly.I am either sterile, postmenopausal, or using effective birth control.I have had liver and kidney issues in the last 6 months.I am a woman who can have children and I have a negative pregnancy test.You have had an allergic reaction or sensitivity to any part of the treatment.My blood pressure is high (≥150/90 mm Hg) despite taking medication.I have not had a gastrointestinal perforation or fistula in the last 6 months.I have cancer that has spread to my brain or spinal cord.I have not had systemic therapy for advanced or metastatic disease.I have not had major surgery or a serious injury in the last 28 days.
- Group 1: 8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
- Group 2: Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
- Group 3: Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
- Group 4: 80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What conditions does Ramucirumab commonly address?
"Ramucirumab is a medication used to treat conditions such as neoplasm metastasis, advanced directives, and urinary bladder cancer. It is also sometimes used as a last-resort treatment for advanced testicular cancer."
What have been the most reported side effects of Ramucirumab?
"While there is some data suggesting that Ramucirumab is safe, it only received a score of 2 because there is no data yet supporting that it is effective."
Are there vacancies in this clinical trial for new patients seeking treatment?
"This study is not admitting any more patients at the current time. This trial was initially posted on May 19th, 2016 and was most recently updated on October 18th, 2020. If you are interested in other trials, there are 400 clinical trials for patients with metastatic cancers and 1050 studies for Ramucirumab that are currently admitting patients."
Are there other ongoing research projects focused on Ramucirumab?
"There are a total of 1050 clinical trials underway that involve Ramucirumab, with 352 of those trials in Phase 3. Most of these medical studies are taking place in Shanghai, but there are 53831 total locations where Ramucirumab clinical trials are being conducted."
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