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Chemotherapy

Neratinib + Chemotherapy for Stomach Cancer

Phase 2
Recruiting
Led By Rutika Mehta, MD, MPH
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

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 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)

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
Oxaliplatin
2011
Completed Phase 4
~2890
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,504 Total Patients Enrolled
Puma Biotechnology, Inc.Industry Sponsor
57 Previous Clinical Trials
10,123 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
118 Previous Clinical Trials
7,854 Total Patients Enrolled
~24 spots leftby Apr 2028
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