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Chemotherapy

Neratinib + Chemotherapy for Stomach Cancer

Phase 2

Recruiting

Led By Dae Won 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

Patients must have pathologically or cytologically confirmed esophageal, gastric or gastroesophageal junction (GEJ) adenocarcinoma by the enrolling institution.

Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 2 years.

Must not have

Has baseline neuropathy > grade 1.

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of Neratinib combined with Trastuzumab, Pembrolizumab and FOLFOX chemotherapy in HER2 overexpressing Gastroesophageal cancers. Safety will be monitored.

Who is the study for?

This trial is for adults with HER2-positive gastroesophageal cancer who haven't had chemotherapy for advanced stage IV disease or have been treatment-free for six months post-adjuvant therapy. They must be in good physical condition, not have severe heart issues, and women of childbearing age must use birth control.

What is being tested?

The study tests the combination of Neratinib with Trastuzumab, Pembrolizumab, and FOLFOX chemotherapy to assess its effectiveness and safety in treating HER2 overexpressing gastroesophageal cancers.

What are the potential side effects?

Potential side effects include diarrhea, liver issues, skin reactions from Neratinib; infusion reactions from Trastuzumab; immune-related effects like inflammation or thyroid problems from Pembrolizumab; and nerve damage or fatigue from FOLFOX.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed as esophageal, gastric, or GEJ adenocarcinoma.

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I am using two birth control methods or am not having sex to join this study.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I do not have severe nerve damage.

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I have cancer that has spread to my brain or spinal cord.

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I have an immune system disorder or take high doses of steroids.

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I have had lung inflammation treated with steroids or have it now.

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I am willing and able to follow the study rules and give consent.

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I do not have serious heart conditions or recent heart issues.

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I have a long-term stomach or bowel problem that causes severe diarrhea.

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Clinical Benefit Rate (CBR)

Duration of Response

Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment with Neratinib with Trastuzumab, Pembrolizumb and mFOLFOXExperimental Treatment5 Interventions

All patients will be treated with combination of neratinib with trastuzumab, pembrolizumab and mFOLFOX. All patients will receive standard dose 5FU/oxaliplatin/trastuzumab every 2 weeks. Pembrolizumab 400 mg intravenously will be administered once every 6 weeks. Neratinib will be dosed 240 mg orally daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neratinib

2014

Completed Phase 2

~1970

Trastuzumab

2014

Completed Phase 4

~5190