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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

Must not have

Previous treatment with TAS-102 or ramucirumab

Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with TAS-102 or ramucirumab before.

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I am not taking any experimental drugs for my cancer.

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I haven't had any serious wounds, ulcers, or bone fractures in the last 28 days.

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I have not had a GI perforation or fistula in the last 6 months.

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I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.

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I am not planning any major surgeries during the trial.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am HIV positive and currently on antiretroviral therapy.

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I have severe liver disease with complications like confusion or fluid in the abdomen.

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I am currently breastfeeding.

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I am a woman who can have children and do not plan to use birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival

Secondary study objectives

Incidence of adverse events

Overall survival (OS)

Quality of life (QOL)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~180