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Tyrosine Kinase Inhibitor

Erlotinib + Tyrosine Kinase Inhibitors for Cancer

Phase 1

Waitlist Available

Led By Alice P Chen, M.D.

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

Patients must have histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist.

Age >=18 years.

Must not have

Pregnant and breastfeeding women are excluded from this study because all 3 study drugs can cause fetal harm, based on preclinical safety data and the respective drug mechanisms of action. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued prior to the first dose of study drug, and women should refrain from nursing throughout the treatment period and for 1 month following the last dose of study drug.

For the erlotinib-lenvatinib arm only: patients with a QTcF interval of >=480 msec at study entry or with congenital long QT syndrome are excluded.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test new combos of drugs to stop/shrink solid tumors returned after treatment. Eligible people aged 18+ with solid tumors can take capsules at home & have clinic visits for tests & scans.

Who is the study for?

Adults over 18 with advanced solid tumors that have worsened after treatment or for which no standard treatment exists. They must be able to swallow pills, not have severe infections like AIDS, and should have stable vital organ functions. People with certain heart conditions, those on specific drugs that affect the trial medications, smokers, pregnant or breastfeeding women are excluded.

What is being tested?

The study is testing combinations of oral capsules: Erlotinib with either Lenvatinib or Axitinib in adults to see if these can stop tumor growth or shrink them. Participants will take these medications daily at home and attend clinic visits for monitoring through various tests including imaging scans.

What are the potential side effects?

Potential side effects may include diarrhea, rash, high blood pressure due to the tyrosine kinase inhibitors (Lenvatinib and Axitinib), as well as liver function abnormalities and reactions related to lung health from Erlotinib.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has worsened despite treatment or there are no standard treatments for it.

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I am 18 years old or older.

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

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I can swallow.

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I have never had an infection that indicates I have AIDS.

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

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I do not have a long QT interval (>=480 msec) or congenital long QT syndrome.

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I am not taking more than two medications for high blood pressure.

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I am not on strong medications that affect liver enzymes and can't be stopped.

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I am not taking medication that increases stomach acidity and can't be stopped.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To establish the safety, tolerability, and maximum tolerated dose (MTD) of the erlotinib-lenvatinib and erlotinib-axitinib combinations in adult patients with advanced solid tumors

Secondary study objectives

To evaluate the plasma pharmacokinetic profiles of erlotinib and either lenvatinib or axitinib when used in combination