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Kinase Inhibitor

Arm II (neratinib maleate, palbociclib) for Ovarian Cancer

Phase 2

Recruiting

Led By Haider S Mahdi

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

One prior line of anti-HER2 therapy is allowed except TKIs or ADCs

Age ≥ 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

"This trial is testing two different treatments for patients with HER2 positive solid tumors - one with neratinib alone and another with a combination of neratinib and palbociclib. These medications

Who is the study for?

This trial is for patients with HER2 positive solid tumors, excluding breast cancer. Participants can have up to five prior treatments and treated brain metastases if stable for 3+ months without steroids. They must not have leptomeningeal disease or RB1 loss/mutation, agree to a biopsy (or provide recent tissue), and show measurable disease.Check my eligibility

What is being tested?

The study compares the effectiveness of neratinib alone versus its combination with palbociclib in treating HER2 positive solid tumors. These kinase inhibitors block proteins that cause cancer cells to multiply, potentially shrinking or stabilizing the tumor.See study design

What are the potential side effects?

Neratinib and palbociclib may cause diarrhea, liver issues, rash, nausea, fatigue, low blood cell counts increasing infection risk; heart problems are possible due to their action on specific proteins involved in tumor growth.

Eligibility Criteria

Inclusion Criteria

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

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I have had one prior anti-HER2 treatment, but not TKIs or ADCs.

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I am 18 years old or older.

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My kidneys filter at least 30 mL of blood per minute.

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I am not currently on IV antibiotics for an infection.

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I can take care of myself but might not be able to do heavy physical work.

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My non-breast cancer tumor is HER2 amplified, confirmed by a specific test.

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My condition has come back or hasn't gone away despite treatment.

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My cancer does not have RB1 loss or deletion.

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I have at least two measurable tumors, one of which can be biopsied.

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I do not have cancer that has spread to the lining of my brain and spinal cord.

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I have never been treated with CDK4/6 inhibitors.

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I don't have any ongoing major stomach or intestine problems.

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I do not have chronic diarrhea, malabsorption, or serious stomach issues.

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I do not have lung problems that make me short of breath when resting.

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I do not have lung disease with current symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression free survival

Secondary outcome measures

Overall survival

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (neratinib maleate, palbociclib)Experimental Treatment8 Interventions

Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.

Group II: Arm I (neratinib maleate)Active Control7 Interventions

Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Biopsy

2014

Completed Phase 4

~1090

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Palbociclib

2017

Completed Phase 3

~3760

Biospecimen Collection

2004

Completed Phase 2

~1700

Echocardiography

2013

Completed Phase 4

~11670

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,371 Total Patients Enrolled

288 Trials studying Ovarian Cancer

73,832 Patients Enrolled for Ovarian Cancer

Haider S MahdiPrincipal InvestigatorNRG Oncology

3 Previous Clinical Trials

189 Total Patients Enrolled

Frequently Asked Questions

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

Are potential participants currently able to apply for enrollment in this ongoing clinical trial?

"As indicated on clinicaltrials.gov, this investigation is presently seeking individuals. The trial was first posted on November 8th, 2024 and last modified on February 27th, 2024."

Answered by AI

At how many distinct sites is this medical study currently being conducted?

"The trial is operational at a total of 12 sites, with bases in Ankeny, Des Moines, and Brighton among other cities. Opting for the nearest site can reduce travel requirements for potential participants."

Answered by AI

What is the safety profile of Arm II (neratinib maleate, palbociclib) for individuals undergoing treatment?

"In the analysis conducted by our team, Arm II (a combination of neratinib maleate and palbociclib) was rated a 2 on safety given its Phase 2 trial status, indicating existing data supporting safety but lacking evidence for efficacy."

Answered by AI

What is the current number of individuals being admitted into this research investigation?

"Indeed, the information on clinicaltrials.gov indicates that this trial is actively seeking volunteers. The initial posting date was 11/8/2024, with the most recent update made on 2/27/2024. This study aims to recruit 70 participants distributed among a dozen locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

2024. "Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06126276.

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