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mTOR Inhibitor

Neratinib + Targeted Therapy for Advanced Cancer

Phase 1

Waitlist Available

Led By Sarina A Piha-Paul

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Subjects must have somatic mutation in KRAS (Patients will be enrolled only on neratinib and trametinib combination ARM)

Any prior neuropathy should be back to baseline or grade 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing neratinib in combination with everolimus, palbociclib, or trametinib to see if it is effective in treating solid tumors that have progressed despite prior treatment and have spread to other parts of the body.

Who is the study for?

Adults with advanced or metastatic solid tumors that are unresponsive to standard treatments and have specific genetic mutations (EGFR, HER2, HER3/4, KRAS) may join. They should be in good physical condition (ECOG 0-1), have adequate organ function, not be pregnant or breastfeeding, agree to use contraception, and not have certain health conditions like active infections or recent major surgery.Check my eligibility

What is being tested?

The trial is testing the effectiveness of neratinib combined with everolimus, palbociclib, or trametinib on patients whose tumors carry certain mutations. It aims to find the safest doses and observe how well these drug combinations can control tumor growth compared to neratinib alone.See study design

What are the potential side effects?

Potential side effects include diarrhea from neratinib; mouth sores and weakened immune system from everolimus; low white blood cell counts leading to increased infection risk from palbociclib; and skin rash as well as vision changes from trametinib. Each drug combination has its own set of possible side effects.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has a KRAS mutation.

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My previous nerve pain or damage has improved to mild or gone.

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My skin rash is mild before starting trametinib.

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My cancer does not respond to standard treatments anymore.

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I am fully active or can carry out light work.

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My cancer has mutations in the EGFR or HER family genes.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Maximum tolerated dose (MTD) of neratinib when given in combination with everolimus, palbociclib, or trametinib

Secondary outcome measures

Determination of pharmacodynamics markers in tissue, blood, and plasma

Incidence of adverse events of neratinib when given in combination with everolimus, palbociclib, or trametinib

Objective response

Side effects data

From 2022 Phase 2 trial • 11 Patients • NCT03094052

100%

Diarrhea

100%

Constipation

82%

Nausea

45%

Fatigue

45%

Abdominal distension

36%

Headache

36%

Dizziness

27%

Hot flashes

27%

Pruritus

27%

Dyspnea

27%

Weight loss

27%

Vomiting

27%

Anorexia

18%

Dysgeusia

18%

Alanine aminotransferase increased

18%

Aspartate aminotransferase increased

18%

Fever

18%

Gastrointestinal disorders - Other, specify

18%

Abdominal pain

18%

Bloating

18%

Sinus bradycardia

18%

Skin and subcutaneous tissue disorders - Other, specify

Anxiety

Cholecystitis

Mucositis oral

Paresthesia

Rash maculo-papular

Upper respiratory infection

Fracture

Back pain

Joint range of motion decreased

Vaginal dryness

Lymphedema

Anal hemorrhage

Muscle weakness upper limb

Musculoskeletal and connective tissue disorder - Other, specify

Vaginal hemorrhage

Chills

Vaginal discharge

Gastroesophageal reflux disease

Creatinine increased

Bruising

Vaginal infection

Arthralgia

Pain

Urinary tract pain

Wheezing

Ejection fraction decreased

Peripheral sensory neuropathy

Insomnia

Flatulence

Flu like symptoms

Rash acneiform

Oral dysesthesia

Stomach pain

General disorders and administration site conditions - Other, specify

Infections and infestations - Other, specify

Fall

Neck pain

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Neratinib)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm III (neratinib, trametinib)Experimental Treatment2 Interventions

Participants receive neratinib PO daily and trametinib PO daily as directed. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (neratinib, palbociclib)Experimental Treatment2 Interventions

Participants receive Neratinib PO daily for 28 days and Palbociclib PO daily for 21 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group III: Arm I (neratinib, everolimus)Experimental Treatment2 Interventions

Participants receive neratinib PO daily and everolimus PO daily. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Everolimus

FDA approved

Neratinib

FDA approved

Palbociclib

FDA approved

Trametinib

FDA approved

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,709 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,574 Total Patients Enrolled

Sarina A Piha-PaulPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

357 Total Patients Enrolled

Media Library

Everolimus (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03065387 — Phase 1

Solid Tumors Research Study Groups: Arm I (neratinib, everolimus), Arm II (neratinib, palbociclib), Arm III (neratinib, trametinib)

Solid Tumors Clinical Trial 2023: Everolimus Highlights & Side Effects. Trial Name: NCT03065387 — Phase 1

Everolimus (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03065387 — Phase 1

Frequently Asked Questions

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

Has Neratinib obtained the necessary clearances to be legally used in medical treatments?

"Neratinib has been deemed relatively safe, scoring a 1 on the risk scale due to pre-clinical data and limited evidence of efficacy."

Answered by AI

Have any other experiments been conducted using Neratinib as a treatment option?

"Presently, 318 Neratinib studies are underway with 37 of these trials in the late-phase 3 stage. Richmond, Virginia is a hub for this type of research and 14667 clinical trial sites around the world are running experiments on this medication."

Answered by AI

Are there any open slots available to enroll in this experiment?

"Clinicaltrials.gov documents that the recruitment of participants for this research endeavor is currently ongoing, with its initial posting occuring on October 31st 2017 and most recent alterations being madeOctober 25th 2022."

Answered by AI

How many participants are included in this research endeavor?

"Affirmative. The clinicaltrials.gov registry confirms that this research is actively searching for participants, with the first listing posted on October 31st 2017 and last updated on October 25th 2022. This trial requires 120 people to be recruited from a single site."

Answered by AI

What medical indications typically warrant Neratinib administration?

"Neratinib is the preferred treatment for unresectable melanoma and can also be used to address a wide range of other medical conditions such as liver transplant rejection, kidney transplant rejection, and Waldenström macroglobulinemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation

2017. "Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03065387.

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