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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

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

Oxaliplatin

2011

Completed Phase 4

~2560

Pembrolizumab

2017

Completed Phase 2

~2010

Trastuzumab

2014

Completed Phase 4

~5190

Neratinib

2014

Completed Phase 2

~1970

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,446 Total Patients Enrolled

Puma Biotechnology, Inc.Industry Sponsor

57 Previous Clinical Trials

9,906 Total Patients Enrolled

National Comprehensive Cancer NetworkNETWORK

115 Previous Clinical Trials

7,599 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have regulatory agencies determined about the efficacy of Neratinib with Trastuzumab, Pembrolizumb and mFOLFOX in treating patients?

"Based on their assessment, Power has given the safety of Treatment with Neratinib with Trastuzumab, Pembrolizumb and mFOLFOX a rating of 2. This is because Phase 2 trials have demonstrated some level of risk mitigation but no data supporting effectiveness yet."

Answered by AI

Are there any available slots in this experiment for participants?

"Affirmative, clinicaltrials.gov's reports demonstrate that this trial is presently enlisting volunteers. It was initially posted on October 24th 2023 and the most recent update to its details occurred on October 25th 2023. This research requires 36 patients from one medical site."

Answered by AI

What is the overall enrollment size for this experiment?

"Affirmative, according to the information provided on clinicaltrials.gov this research is still recruiting participants. It was initially posted online on October 24th 2023 and last revised a day later; with 36 subjects being sought from one medical institution."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer

2024. "Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06109467.