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Tyrosine Kinase Inhibitor

Lapatinib Before Surgery for Brain Tumor

Phase 1
Waitlist Available
Led By Timothy F Cloughesy
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 proven World Health Organization (WHO) grade IV glioblastoma/gliosarcoma or WHO grade III glioma which is progressive or recurrent following radiation therapy +/- chemotherapy
Patients must have a Karnofsky performance status >= 60%
Must not have
Patients with prior therapy with EGFR inhibitors are ineligible
Patients receiving P-glycoprotein (P-gp) inhibitors are ineligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is testing how well lapatinib ditosylate works in treating patients with high-grade glioma that has come back. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?
This trial is for adults with high-grade glioma brain tumors that have returned after treatment. Eligible patients must have had prior therapy, be able to undergo MRI and surgery, and have a certain level of physical function. They should not be on specific drugs or have other serious health issues, and women must agree to use contraception.
What is being tested?
The study tests how well lapatinib ditosylate works when given before surgery in patients with recurrent high-grade gliomas. The drug aims to block enzymes needed for tumor cell growth, potentially slowing the disease's progression.
What are the potential side effects?
Potential side effects of lapatinib ditosylate may include diarrhea, skin rashes, fatigue, nausea, liver problems like hepatitis or abnormal liver function tests; heart issues such as decreased heart function; and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor is aggressive and has returned or worsened after treatment.
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I can care for myself but may need occasional help.
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I have no other cancers except possibly treated skin, cervical, breast, or bladder cancer.
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I can take medication by mouth, including tablets.
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My brain tumor is growing or has returned, and it can be seen on an MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never been treated with EGFR inhibitors.
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I am not taking P-glycoprotein inhibitors.
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My heart's electrical cycle is normal and I'm not on QT-prolonging drugs.
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I am HIV-positive and not on strong CYP3A4 medicines.
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I do not have an active liver or bile duct disease needing antiviral treatment.
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My blood, kidney, and liver functions are normal.
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I am not taking any medication for epilepsy that increases enzyme activity.

Timeline

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
To Determine the Lapatinib Ditosylate Intratumoral Concentration (Pharmacokinetics)
To Determine the Ratio of Phosphorylated (p)EGFR/Total EGFR (PD) in Tumor Tissue
Secondary study objectives
Ex-vivo Sensitivity of Tumor Sphere Cultures to Lapatinib Ditosylate
Incidence of Adverse Events (AEs)
Inhibition of tumor cell proliferation (KI-67)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group A (lapatinib ditosylate, surgery)Experimental Treatment5 Interventions
Patients receive lapatinib ditosylate PO BID on days -2 to 0. Within 3-5 hours after last dose of lapatinib ditosylate, patients undergo surgical resection of tumor on day 0. Within 30 days of surgical resection of tumor, patients receive lapatinib ditosylate BID for 2 days every 7 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Reference Group (surgery, lapatinib ditosylate)Active Control5 Interventions
Patients undergo surgery on day 0. Within 30 days of surgical resection of tumor, patients receive lapatinib ditosylate BID for 2 days every 7 days. 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
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Lapatinib
2006
Completed Phase 3
~3530
Lapatinib Ditosylate
2006
Completed Phase 3
~580

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,868 Previous Clinical Trials
41,010,808 Total Patients Enrolled
Timothy F CloughesyPrincipal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Lapatinib Ditosylate (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02101905 — Phase 1
Anaplastic Ependymoma Research Study Groups: Group A (lapatinib ditosylate, surgery), Reference Group (surgery, lapatinib ditosylate)
Anaplastic Ependymoma Clinical Trial 2023: Lapatinib Ditosylate Highlights & Side Effects. Trial Name: NCT02101905 — Phase 1
Lapatinib Ditosylate (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02101905 — Phase 1
~3 spots leftby Oct 2025
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