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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
Must not have
Hypersensitivity to lapatinib or paclitaxel
Receiving medications that inhibit or induce CYP3A4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not allergic to lapatinib or paclitaxel.
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I am taking medication that affects liver enzyme CYP3A4.
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I have been diagnosed with congestive heart failure.
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I do not have any unmanaged ongoing illnesses.
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I have a condition that prevents my body from absorbing nutrients properly.
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My nerve damage is mild or worse.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose-limiting toxicity
Progression-free survival.
Secondary study objectives
Change in plasma concentration of lapatinib.
Other study objectives
ABCB1 Expression

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

Find a Location

Who is running the clinical trial?

Frederick R. Ueland, M.D.Lead Sponsor
5 Previous Clinical Trials
831 Total Patients Enrolled
1 Trials studying Ovarian Cancer
13 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,986 Total Patients Enrolled
288 Trials studying Ovarian Cancer
76,468 Patients Enrolled for Ovarian Cancer
Frederick Ueland, MDPrincipal InvestigatorMarkey Cancer Center
2 Previous Clinical Trials
51 Total Patients Enrolled
1 Trials studying Ovarian Cancer
13 Patients Enrolled for Ovarian Cancer

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
~2 spots leftby Jun 2025
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