What side effects are associated with this type of intervention?

Common treatments for Gastroesophageal Junction Adenocarcinoma, such as ramucirumab and paclitaxel, often result in side effects including hypertension, fatigue, neutropenia, and gastrointestinal issues like nausea and diarrhea. Chemotherapy regimens involving fluorouracil, leucovorin, oxaliplatin, and docetaxel can also cause neuropathy, mucositis, and increased risk of infection due to bone marrow suppression. These side effects vary in severity and frequency, and patients should discuss them with their healthcare provider to manage and mitigate potential risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Gastroesophageal Junction (GEJ) Adenocarcinoma. Ramucirumab, an anti-angiogenic agent, has been approved in combination with paclitaxel for advanced or metastatic GEJ adenocarcinoma following prior chemotherapy, as demonstrated in the RAINBOW trial. Additionally, pembrolizumab, an anti-PD-1 monoclonal antibody, has been approved for patients with recurrent, locally advanced, or metastatic GEJ adenocarcinoma expressing high levels of PD-L1. Nivolumab, another anti-PD-1 therapy, has also been approved for similar indications. These treatments focus on targeting specific pathways involved in cancer progression and have shown efficacy in improving patient outcomes.

What other types of research exist?

Promising novel alternatives to TRK-950 for gastroesophageal junction adenocarcinoma patients include: 1) Ramucirumab combined with paclitaxel, which is already being compared with TRK-950 in clinical studies. 2) PI3K/PTEN/AKT/mTOR pathway inhibitors, such as temsirolimus, which have shown promise in other cancer types. 3) Antiangiogenic multikinase inhibitors like cabozantinib and vandetanib, which have demonstrated efficacy in other cancers and could be explored for GEJ adenocarcinoma. 4) RET-selective inhibitors such as selpercatinib and pralsetinib, which are effective in RET-mutated tumors and may offer benefits if applicable to GEJ adenocarcinoma.

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TRK-950 + Ramucirumab + Paclitaxel for Stomach Cancer

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

No Placebo-Only Group

Summary

This trial is testing a new drug, TRK-950, combined with two existing cancer drugs in patients with a specific type of stomach cancer. The goal is to see if this combination can better control cancer growth and improve survival compared to the existing treatments alone.

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.

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).

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to date of documented disease progression, up to approximately 24 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

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

+9 more

Awards & Highlights

No Placebo-Only Group

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

Trial 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

Ramucirumab

2017

Completed Phase 3

~5050

Paclitaxel

2011

Completed Phase 4

~5450

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Gastroesophageal Junction (GEJ) Adenocarcinoma include targeted therapies, chemotherapy, and immunotherapy. Ramucirumab is a monoclonal antibody that inhibits the vascular endothelial growth factor receptor 2 (VEGFR-2), thereby blocking angiogenesis, which is crucial for tumor growth and metastasis. Paclitaxel is a chemotherapeutic agent that stabilizes microtubules, preventing cell division and leading to cancer cell death. TRK-950, an investigational drug, is being studied for its potential anti-cancer properties, possibly through mechanisms such as immune modulation or direct cytotoxicity. These treatments are significant for GEJ adenocarcinoma patients as they target specific pathways involved in tumor growth and survival, potentially improving treatment efficacy and patient outcomes.