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Tyrosine Kinase Inhibitor

B for Tumors

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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 outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: BExperimental Treatment2 Interventions

Erlotinib with axitinib combination

Group II: AExperimental Treatment2 Interventions

Erlotinib with lenvatinib combination

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axitinib

2020

Completed Phase 2

~3050

Erlotinib

2011

Completed Phase 4

~2290

Lenvatinib

2005

Completed Phase 4

~2690

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,658 Previous Clinical Trials

40,924,419 Total Patients Enrolled

3 Trials studying Tumors

1,244 Patients Enrolled for Tumors

Alice P Chen, M.D.Principal InvestigatorNational Cancer Institute (NCI)

16 Previous Clinical Trials

3,598 Total Patients Enrolled

Sarah J Shin, M.D.Principal InvestigatorNational Cancer Institute (NCI)

Frequently Asked Questions

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

Do seniors aged eighty and above qualify for this research endeavor?

"The stipulations for participation in this medical experiment specify that all participants must between 18 and 120 years old. In contrast, there are 319 trials open to minors and 2346 studies available for those aged 65 or more."

Answered by AI

What criteria must a person meet to qualify for this clinical investigation?

"To join this clinical trial, individuals must possess the relevant neoplasms and fall between 18 to 120 years of age. This medical study is accepting a maximum of 70 participants."

Answered by AI

Has B attained the Food and Drug Administration's blessing?

"Limited clinical data exists on B's safety and efficacy, thus it received a score of 1."

Answered by AI

Are enrolments for this clinical trial still ongoing?

"The clinicaltrials.gov website displays that this medical trial is now closed to new participants, with its original posting on December 13th 2023 and latest edit occurring a week later on the 7th of December 2023. Despite the cessation of recruitment for this particular study, there are 2,541 additional studies actively looking for volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Erlotinib in Combination With Select Tyrosine Kinase Inhibitors in Adult Patients With Advanced Solid Tumors

2024. "Erlotinib in Combination With Select Tyrosine Kinase Inhibitors in Adult Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06161558.

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