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Tyrosine Kinase Inhibitor

Lapatinib + Paclitaxel for Ovarian Cancer

Phase 1

Waitlist Available

Led By Frederick Ueland, MD

Research Sponsored by Frederick R. Ueland, M.D.

Eligibility Criteria Checklist

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

Must have

ECOG performance status less than or equal to 2

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat ovarian cancer that has resisted other treatments.

Who is the study for?

This trial is for people with ovarian cancer that came back within a year after platinum-based chemo. They should be fairly active (ECOG ≤2), have good organ and bone marrow function, and able to consent. It's not for those allergic to the drugs being tested, with uncontrolled sickness, heart failure, trouble absorbing food, taking certain other meds or any experimental cancer treatments.Check my eligibility

What is being tested?

The study tests increasing doses of Lapatinib combined with Paclitaxel in patients whose ovarian cancer resisted platinum chemotherapy. The goal is to find the safest dose level that can be used in future phase II trials.See study design

What are the potential side effects?

Lapatinib may cause diarrhea, liver issues, rashes or fatigue; Paclitaxel might lead to nerve damage, joint pain or immune system effects. Side effects vary by individual and drug dosage.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

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

Treatment Details

Study Objectives

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

Primary outcome measures

Dose-limiting toxicity

Progression-free survival.

Secondary outcome measures

Change in plasma concentration of lapatinib.

Other outcome measures

ABCB1 Expression

Trial Design

4Treatment groups

Experimental Treatment

Group I: Lapatinib - Group 4Experimental Treatment1 Intervention

Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).

Group II: Lapatinib - Group 3Experimental Treatment1 Intervention

Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).

Group III: Lapatinib - Group 2Experimental Treatment1 Intervention

Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).

Group IV: Lapatinib - Group 1Experimental Treatment1 Intervention

Patients in this group will receive Lapatinib (500mg PO BID) and Paclitaxel (80mg/m2).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Frederick R. Ueland, M.D.Lead Sponsor

4 Previous Clinical Trials

818 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,138 Total Patients Enrolled

285 Trials studying Ovarian Cancer

73,751 Patients Enrolled for Ovarian Cancer

Frederick Ueland, MDPrincipal InvestigatorMarkey Cancer Center

1 Previous Clinical Trials

38 Total Patients Enrolled

Media Library

Lapatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04608409 — Phase 1

Ovarian Cancer Research Study Groups: Lapatinib - Group 1, Lapatinib - Group 2, Lapatinib - Group 3, Lapatinib - Group 4

Ovarian Cancer Clinical Trial 2023: Lapatinib Highlights & Side Effects. Trial Name: NCT04608409 — Phase 1

Lapatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04608409 — Phase 1

Frequently Asked Questions

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

Does this clinical research involve participants aged 45 or over?

"Eligible applicants for this medical trial must be aged 18 to 100 years old. Furthermore, there are 48 trials that cater specifically to those below the age of majority and 1498 studies designed for individuals over 65."

Answered by AI

What is the scope of participants in this research initiative?

"Affirmative, the details published on clinicaltrials.gov confirm that this medical research is presently recruiting participants. This trial was first made available to potential applicants in mid-November 2020 and has since been updated late December 2021. 15 individuals are needed from a single site for successful completion of the project."

Answered by AI

What information has been gathered from prior investigations of Lapatinib and Paclitaxel?

"Currently, 851 trials are in progress for Lapatinib and Paclitaxel. Of those studies, 235 are currently at the Phase 3 stage of development. The majority of these tests occur in Woolloongabba, Queensland though there is a total of 46277 sites conducting such research worldwide."

Answered by AI

To what extent has Lapatinib and Paclitaxel been sanctioned by the Federal Drug Administration?

"Due to the limited evidence in support of Lapatinib and Paclitaxel's efficacy, our experts at Power assign this drug combination a score of 1 on the safety scale."

Answered by AI

Are there any restrictions on who can enroll in this clinical investigation?

"This clinical trial seeks 15 subjects who are between 18 and 100 years old, with a diagnosis of ovarian cancer. Additionally, these applicants must have an ECOG performance status at or below 2 to be eligible."

Answered by AI

Are new patients being enrolled at this point in the trial?

"According to the information provided by clinicaltrials.gov, this study is actively seeking volunteers for their trials which initially commenced on November 16th 2020 and was most recently updated December 7 2021."

Answered by AI

What conditions are Lapatinib and Paclitaxel typically prescribed to treat?

"Lapatinib and Paclitaxel are conventional treatments for neoplasm metastasis, however they can also provide relief to those struggling with kaposi sarcoma, advanced directives, or fallopian tubes cancer."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer

Frederick R. Ueland, M.D. 2021. "Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04608409.

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