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Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel for Gastroesophageal Junction Adenocarcinoma
Phase 2
Recruiting
Research Sponsored by Toray Industries, Inc
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 of 0 or 1.
The patient is eligible to receive Ramucirumab + Paclitaxel as second-line therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment to date of documented disease progression, up to approximately 24 months
Awards & highlights
Study Summary
This trial will study the effects of a new drug used with two other drugs to treat stomach cancer.
Who is the study for?
This trial is for adults with advanced gastric or gastro-esophageal junction adenocarcinoma that has worsened after first-line therapy. They must be fit enough for second-line treatment, have a life expectancy of at least 3 months, and measurable disease on scans. Participants need to function well daily (ECOG 0-1) and have good organ function.Check my eligibility
What is being tested?
The study tests TRK-950 combined with Ramucirumab and Paclitaxel against just Ramucirumab and Paclitaxel in patients with stomach cancer. It aims to find the best dose of TRK-950, check its safety, effectiveness, and how the body reacts to it (antibody development).See study design
What are the potential side effects?
Possible side effects include those common to chemotherapy like fatigue, hair loss, nausea; specific ones related to Ramucirumab such as high blood pressure; and any unknown risks from the new drug TRK-950.
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 eligible for Ramucirumab + Paclitaxel as my second treatment option.
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My cancer can be measured on a CT scan.
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My cancer is advanced stomach or GEJ cancer that cannot be surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment to date of documented disease progression, up to approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment to date of documented disease progression, up to approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Adverse Events of Special Interest (AESI)
Best overall response (BOR)
Change from Baseline in Patient Reported Quality of Life assessed by Questionnaire - EuroQOL Five Dimensions questionnaire 3L (EQ-5D-3L) scores
+20 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: TRK-950(10 mg/kg)+Ramucirumab+PaclitaxelExperimental Treatment3 Interventions
Participants who will be randomized to receive a 10 mg/kg intravenous(IV) dose of TRK-950 on days 1, 8, 15 and 22 in combination with 8 mg/kg IV dose of ramucirumab on days 1 and 15 and 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.
Group II: Arm A: TRK-950(5 mg/kg)+Ramucirumab+PaclitaxelExperimental Treatment3 Interventions
Participants who will be randomized to receive a 5 mg/kg intravenous(IV) dose of TRK-950 on days 1, 8, 15 and 22 in combination with 8 mg/kg IV dose of ramucirumab on days 1 and 15 and 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.
Group III: Arm C: Ramucirumab+PaclitaxelActive Control2 Interventions
Participants who will be randomized to receive a 8 mg/kg IV dose of ramucirumab on Days 1 and 15 in combination with 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TRK-950
2017
Completed Phase 1
~40
Paclitaxel
2011
Completed Phase 4
~5380
Ramucirumab
2017
Completed Phase 3
~5050
Find a Location
Who is running the clinical trial?
Toray Industries, IncLead Sponsor
21 Previous Clinical Trials
2,254 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently included in this research project?
"Affirmative. According to the records hosted on clinicaltrials.gov, this medical experiment first posted on October 4th 2023 is presently recruiting participants with an aim of enlisting 146 individuals from 8 different sites."
Answered by AI
Is the research team currently seeking participants?
"The information displayed on clinicaltrials.gov indicates that this research study is currently processing patient applications. It was initially posted on October 4th 2023 and underwent its last revision on December 14th of the same year."
Answered by AI
How many Canadian sites are currently conducting this investigation?
"Eight medical sites across the globe are currently enrolling patients for this study. This includes Dallas, Irvine and Chuo Ku amongst other locations. To alleviate travel demands it is advisable to select the closest site available to you if participating in the trial."
Answered by AI
Has the combination of TRK-950(5 mg/kg), Ramucirumab, and Paclitaxel received approval from the FDA?
"According to our internal evaluation, the safety of Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel is rated as a 2. This score takes into consideration that Phase 2 trials have some evidence supporting their safety but not yet any proof for efficacy."
Answered by AI
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