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Monoclonal Antibodies
TAS 102 + Ramucirumab for Stomach Cancer
Phase 2
Waitlist Available
Led By Dae W Kim, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable or non-measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Stage IV or recurrent disease is required. An irradiated lesion is considered evaluable only if it has shown enlargement since the completion of last radiation
Participants must have received and progressed with prior therapy. Prior therapy with ramucirumab is not allowed. Participants must have recovered from the toxic effects of the previous anti-cancer chemotherapy (with the exception of alopecia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after end of study participation, an average of 6.5 months
Awards & highlights
Study Summary
This trial is testing a new combination therapy for stomach cancer that has progressed despite treatment. The goal is to see if it is safe and effective.
Who is the study for?
This trial is for adults with advanced, refractory gastric or gastroesophageal junction adenocarcinoma who've had prior therapy but not with ramucirumab. They must have a life expectancy over 3 months, good organ function, and no recent major surgeries or other cancer treatments. Women of childbearing age need a negative pregnancy test and all participants must agree to use contraception.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining TAS 102 with Ramucirumab (CYRAMZA) in treating stomach cancer that hasn't responded to previous therapies. It aims to find out if this drug combination can help patients with this specific type of cancer.See study design
What are the potential side effects?
Potential side effects may include typical reactions from chemotherapy such as nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems. Ramucirumab might cause high blood pressure, bleeding issues, or infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is at stage IV or has come back and can be measured by specific criteria.
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I have had cancer treatment before, but not with ramucirumab, and have recovered from side effects.
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I am fully active or can carry out light work.
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My diagnosis is stomach or GEJ cancer confirmed by tissue analysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks after end of study participation, an average of 6.5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after end of study participation, an average of 6.5 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
Number of Participants With at Least One Adverse Event
Objective Response Rate
Progression Free Survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: TAS 102 and RamucirumabExperimental Treatment2 Interventions
TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAS 102
2017
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,469 Total Patients Enrolled
Dae W Kim, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
52 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breast-feeding.I have not had severe bleeding in the last 4 weeks.My cancer has spread to my brain.I have been treated with specific medications before.My high blood pressure is not under control.My cancer is at stage IV or has come back and can be measured by specific criteria.I am fully active or can carry out light work.I have heart-related health issues.I cannot swallow pills or have certain stomach/intestine problems.I have not had a stroke or brain bleed in the last 6 months.I have severe, ongoing protein in my urine.I need specific treatments during the study.My blood, liver, and kidney tests meet the required health standards.My diagnosis is stomach or GEJ cancer confirmed by tissue analysis.I am not pregnant and have taken a test within the last week to confirm.I have had cancer treatment before, but not with ramucirumab, and have recovered from side effects.I have severe liver disease or have had swelling of the brain due to liver failure.I haven't had chemotherapy, major surgery, or certain therapies in the last 28 days.I have not had major surgery or any unhealed wounds in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: TAS 102 and 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.
When will TAS 102 be cleared for public use in the United States?
"TAS 102 is classified as a phase 2 medication, meaning that while there is some safety data, none of it supports efficacy."
Answered by AI
Is patient recruitment for this trial still open?
"Unfortunately, this cancer treatment clinical trial is not recruiting at the moment. Although, it is worth mentioning that the study was last active on 11/10/2022 and originally posted on 12/20/2018. There are presently 1151 trials for adenocarcinoma and 88 for TAS 102 actively enrolling patients."
Answered by AI
What maladies does TAS 102 typically help to alleviate?
"TAS 102 has been shown to be effective in treating patients that have adenocarcinoma, have received oxaliplatin chemotherapy in the past, and have been treated with anti-vegf."
Answered by AI
Is TAS 102 a new medication?
"TAS 102 is currently being trialled in 88 separate studies, 13 of which are Phase 3 trials. The majority of these studies take place in Saint Louis, but there are 4169 locations worldwide where TAS 102 is being studied as a potential treatment."
Answered by AI
How many individuals are receiving care through this research project?
"Currently, this study is not looking for new patients. The listing was first posted on December 20th, 2018 and last updated on November 10th, 2020. However, if you are seeking other trials, there are 1,251 studies actively admitting patients with adenocarcinoma and 88 TAS 102 studies that still need participants."
Answered by AI
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