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Tyrosine Kinase Inhibitor

Neratinib for Resistant or Recurrent Cancer

Phase 1 & 2

Waitlist Available

Led By Tanya Trippett, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Patient must be able to swallow tablet or have existing gastrostomy feeding tube to enable administration of tablet

Age: Phase 1 - ≥ 3 and ≤ 21 years of age at time of enrollment, Phase 2 - ≥ 3 and ≤ 21 years of age at diagnosis

Must not have

Patients with previous allogeneic stem cell transplant (SCT) meeting specific criteria

Inadequate marrow function in Cohort 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of neratinib, and its effects on patients and cancer.

Who is the study for?

This trial is for children and young adults aged 3 to 21 with recurrent or resistant cancers like brain tumors, lymphoma, leukemia, and solid tumors. They must have tried at least one treatment before, be able to swallow tablets or use a feeding tube, and have no severe heart issues. Females of childbearing age and males must agree to effective contraception.

What is being tested?

The study is testing the safety of different doses of Neratinib on young patients with cancer that has returned or didn't respond to previous treatments. It aims to discover both positive and negative effects this drug may have on their condition.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of Neratinib can include diarrhea, nausea, abdominal pain, fatigue, rash. Side effects vary by individual; some may experience more severe reactions.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow pills or have a feeding tube.

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I am between 3 and 21 years old.

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I have been diagnosed with a solid tumor or lymphoma.

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My condition has returned or hasn't responded to treatment, and no standard treatments are effective.

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I have tried at least one treatment that didn't work for me.

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I have tissue available for protein and genomic tests.

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I agree to use barrier contraception during and for 3 months after treatment.

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My heart's pumping ability is within a healthy range.

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I am mostly active and can do some activities or work.

Exclusion Criteria

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

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I had a stem cell transplant from a donor and meet specific criteria.

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My blood cell counts are too low.

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I have a heart condition with a long QT interval.

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I have been diagnosed with HIV/AIDS.

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I have a history of hepatitis C or currently have active hepatitis B.

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I do not have any uncontrolled illness or social situations that would stop me from following the study's requirements.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

the number of patients who have experienced Dose Limiting Toxicity

Side effects data

From 2022 Phase 2 trial • 11 Patients • NCT03094052

100%

Diarrhea

100%

Constipation

82%

Nausea

45%

Abdominal distension

45%

Fatigue

36%

Dizziness

36%

Headache

27%

Dyspnea

27%

Hot flashes

27%

Anorexia

27%

Vomiting

27%

Pruritus

27%

Weight loss

18%

Skin and subcutaneous tissue disorders - Other, specify

18%

Dysgeusia

18%

Bloating

18%

Fever

18%

Abdominal pain

18%

Gastrointestinal disorders - Other, specify

18%

Aspartate aminotransferase increased

18%

Alanine aminotransferase increased

18%

Sinus bradycardia

Back pain

Muscle weakness upper limb

Neck pain

Rash acneiform

Lymphedema

Rash maculo-papular

Vaginal dryness

Anal hemorrhage

Paresthesia

Gastroesophageal reflux disease

Pain

Infections and infestations - Other, specify

Urinary tract pain

Flu like symptoms

Fracture

Flatulence

Mucositis oral

Chills

General disorders and administration site conditions - Other, specify

Ejection fraction decreased

Oral dysesthesia

Peripheral sensory neuropathy

Creatinine increased

Upper respiratory infection

Vaginal infection

Stomach pain

Bruising

Fall

Joint range of motion decreased

Musculoskeletal and connective tissue disorder - Other, specify

Arthralgia

Vaginal discharge

Vaginal hemorrhage

Wheezing

Anxiety

Insomnia

Cholecystitis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Neratinib)

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: NeratinibExperimental Treatment1 Intervention

There are 2 parts to this study: a Phase I part and a Phase II part. The Phase I portion is known as the dose escalation phase where neratinib will be tested in groups of 3-6 patients to establish the maximum tolerated dose (MTD). The phase II portion will determine whether the MTD shows a response to the tumor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neratinib

2014

Completed Phase 2

~1970

0 / 16Eligibility criteria met