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Protein Kinase Inhibitor
Ramucirumab/Merestinib + Chemotherapy for Biliary Tract Cancer
Phase 2
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a histologically or cytologically confirmed diagnosis of non-resectable, recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or Ampulla of Vater)
Have adequate organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, follow up (up to 48 months)
Awards & highlights
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.
Who is the study for?
This trial is for adults with advanced or metastatic biliary tract cancer who haven't had previous systemic therapy for their condition. They must be relatively healthy and active (with good performance status), have measurable disease, provide tissue samples, have proper organ function and biliary drainage, and use effective contraception if of childbearing potential.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of two drugs: Ramucirumab or Merestinib, each combined with Cisplatin and Gemcitabine chemotherapy. Participants will also receive either a placebo pill or IV to compare against these treatments.See study design
What are the potential side effects?
Potential side effects include high blood pressure, bleeding problems, fatigue, stomach issues like nausea or vomiting from chemo drugs; Ramucirumab may cause infusion reactions while Merestinib could affect liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of biliary tract cancer that cannot be surgically removed.
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My organs are functioning well.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My bile ducts are draining properly.
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I am either sterile, postmenopausal, or using effective birth control.
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I am a woman who can have children and I have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, follow up (up to 48 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, follow up (up to 48 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Change From Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep)
Change From Baseline in Participant-Reported EQ-5D-5L Visual Analog Scale (VAS) Score
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
+6 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² GemcitabineExperimental Treatment3 Interventions
Participants received 80 mg merestinib orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for merestinib therapy).
Group II: 8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² GemcitabineExperimental Treatment3 Interventions
Participants received 8 mg/kg ramucirumab plus 25 mg/square meter (mg/m²) cisplatin and 1000 mg/m² gemcitabine intravenously (IV) on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for ramucirumab therapy).
Group III: Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² GemcitabinePlacebo Group3 Interventions
Participants received placebo (indistinguishable to merestinib) orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days. Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
Group IV: Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² GemcitabinePlacebo Group3 Interventions
Participants received placebo (indistinguishable and equivalent volume to ramucirumab) plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
FDA approved
Merestinib
Not yet FDA approved
Cisplatin
FDA approved
Gemcitabine
FDA approved
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,620 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,943 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 1 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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