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Anti-mitotic Agent
Ramucirumab + Trifluridine/Tipiracil or Paclitaxel for Gastric Cancer
Phase 2
Recruiting
Led By Mohamad B Sonbol
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying two different combinations of drugs to see which is better at treating patients with advanced gastric or gastroesophageal junction cancer.
Who is the study for?
Adults with advanced gastric or gastroesophageal junction cancer that has worsened within 6 months after treatment can join. They must have had prior chemotherapy, be in good physical condition, and able to take oral meds. Pregnant women, nursing mothers, those with recent serious health issues like heart attacks or uncontrolled hypertension are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness of ramucirumab combined with either trifluridine/tipiracil or paclitaxel in patients who've already been treated for advanced stomach cancers. Ramucirumab targets blood vessel growth in tumors while the other drugs aim to damage tumor DNA or block cell growth.See study design
What are the potential side effects?
Possible side effects include high blood pressure from ramucirumab; fatigue, nausea, low white blood cell counts from trifluridine/tipiracil; and hair loss, numbness in fingers and toes from paclitaxel. Each patient's experience may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am 18 years old or older.
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I am receiving Trastuzumab for my HER2-positive condition.
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I need a second treatment because the first one didn't work or caused side effects.
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My cancer is confirmed as stomach or gastroesophageal junction adenocarcinoma.
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I have been treated with specific chemotherapy drugs for my condition.
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My kidney function, measured by creatinine levels, is within the required range.
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I can take pills by mouth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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
Secondary outcome measures
Incidence of adverse events
Overall survival (OS)
Quality of life (QOL)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (TAS-102, ramucirumab)Experimental Treatment3 Interventions
Patients receive TAS-102 PO BID on days 1-5 and 8-12, and ramucirumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (paclitaxel, ramucirumab)Active Control3 Interventions
Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15, and ramucirumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
2017
Completed Phase 3
~5050
Trifluridine and Tipiracil Hydrochloride
2019
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,020 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,252 Total Patients Enrolled
Mohamad B SonbolPrincipal InvestigatorAcademic and Community Cancer Research United
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study drug's effects on unborn babies are unknown.I have been treated with TAS-102 or ramucirumab before.I received taxane therapy less than 6 months ago.I have not had a serious blood clot in the last 3 months.My advanced cancer has worsened within 6 months after my last treatment.I am not taking any experimental drugs for my cancer.I haven't had any serious wounds, ulcers, or bone fractures in the last 28 days.I have not had a GI perforation or fistula in the last 6 months.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.I am not planning any major surgeries during the trial.I am fully active or can carry out light work.I am on warfarin with INR <= 3.0, or on heparin/LMWH without recent bleeding or high bleeding risk.I have not had a heart attack or stroke in the last 6 months.I have not had severe GI bleeding in the last 3 months.I have been on a stable dose of blood thinner for at least 14 days.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am HIV positive and currently on antiretroviral therapy.I am 18 years old or older.I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 3 years.I am receiving Trastuzumab for my HER2-positive condition.I switched from warfarin to low molecular weight heparin and my blood clotting levels are stable.My high blood pressure is not well controlled despite taking medication.I am set for a second treatment after my first one, which included specific drugs, didn't work or caused side effects.I have severe liver disease with complications like confusion or fluid in the abdomen.I need a second treatment because the first one didn't work or caused side effects.I am on a daily antiplatelet medication but not more than 325 mg of aspirin.My cancer is confirmed as stomach or gastroesophageal junction adenocarcinoma.I have been treated with specific chemotherapy drugs for my condition.I am either postmenopausal, surgically sterile, or using effective birth control.I am currently breastfeeding.My cancer returned within 6 months after finishing chemotherapy.My kidney function, measured by creatinine levels, is within the required range.I am a woman who can have children and do not plan to use birth control.I can take pills by mouth.I have signed the consent form for this trial within the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (TAS-102, ramucirumab)
- Group 2: Arm B (paclitaxel, ramucirumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 are some risks associated with Quality-of-Life Assessment?
"While there is some data supporting the safety of Quality-of-Life Assessment, it received a score of 2 because this is only a Phase 2 trial and thus there is no efficacy data."
Answered by AI
Could you please share some similar studies to the Quality-of-Life Assessment clinical trial?
"At this moment, 942 clinical trials regarding Quality-of-Life Assessment are ongoing with 242 in Phase 3. Even though a large quantity of the research for Quality-of-Life Assessment is based in Woolloongabba, Queensland, there are still 48357 other locations conducting these studies."
Answered by AI
How many different hospitals are running this clinical trial?
"This study is currently enrolling patients at 11 sites across the United States of America. If you are considering participating in this trial, it would be most convenient to select a site near your location to minimize travel requirements."
Answered by AI
What do doctors hope to learn from Quality-of-Life Assessments?
"Quality-of-Life Assessment can be used to treat patients with ras wild-type, who have a history of anti-egfr therapy, and are suffering from locally advanced non-small cell lung cancer or metastatic bladder cancer."
Answered by AI
Are there any current vacancies for this clinical trial?
"Yes, according to the information on clinicaltrials.gov, this study is looking for participants. The trial was first posted on 6/16/2021 and updated on 4/4/2022. There are 11 locations enrolling a total of 116 patients."
Answered by AI
How many test subjects are part of this experiment?
"The clinical trial is, as of now, recruiting patients from 11 different centres with the goal to enroll 116 individuals in total. The study was first posted on June 16th, 2021 and most recently updated on April 4th, 2022 according to data available on clinicaltrials.gov"
Answered by AI
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