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Kinase Inhibitor

Neratinib or Neratinib + Palbociclib for 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

No Placebo-Only Group

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.

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.

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

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

Primary study objectives

Progression free survival

Secondary study objectives

Overall survival

Awards & Highlights

No Placebo-Only Group

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

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

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Multigated Acquisition Scan

2015

Completed Phase 3

~270