NCT04608409

Brief Summary

This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 ovarian-cancer

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 17, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 29, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

3.2 years

First QC Date

October 22, 2020

Results QC Date

May 28, 2025

Last Update Submit

June 17, 2025

Conditions

Ovarian Cancer

Keywords

platinum-resistant

Outcome Measures

Primary Outcomes (2)

  • Progression-free Survival.

    Number of patients with progression-free survival at one year.

    One year

  • Number of Participants With Dose-limiting Toxicity

    Dose limiting toxicity (DLT) is calculated as the total number of patients experiencing DLTs divided by the total number treated.

    4 weeks

Secondary Outcomes (3)

  • Change in Plasma Concentration of Lapatinib Cycle 1

    15 days (on day 8 and 15)

  • Change in Plasma Concentration of Lapatinib Cycle 2

    15 days (on day 8 and 15)

  • Change in Plasma Concentration of Lapatinib Cycle 3

    15 days (on day 8 and 15)

Other Outcomes (1)

  • ABCB1 Expression

    15 days (on day 1, 8 and 15)

Study Arms (3)

Lapatinib - Group 1

EXPERIMENTAL

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

Drug: Lapatinib and Paclitaxel

Lapatinib - Group 2

EXPERIMENTAL

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

Drug: Lapatinib and Paclitaxel

Lapatinib - Group 3

EXPERIMENTAL

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

Drug: Lapatinib and Paclitaxel

Interventions

Lapatinib and PaclitaxelDRUG

Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.

Lapatinib - Group 1Lapatinib - Group 2Lapatinib - Group 3

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically or cytologically confirmed ovarian cancer who recur within 12 months of platinum-based chemotherapy
  • ECOG performance status less than or equal to 2
  • Adequate organ and marrow function at baseline
  • ability to sign a written informed consent document

You may not qualify if:

  • hypersensitivity to lapatinib or paclitaxel
  • uncontrolled intercurrent illness
  • receiving medications that inhibit or induce CYP3A4
  • malabsorption syndrome
  • congestive heart failure
  • receiving any other anti-cancer investigational agents
  • baseline neuropathy greater than Grade 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

LapatinibPaclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Dr. Frederick Ueland
Organization
University of Kentucky
frederick.ueland@uky.edu
859-257-1613

Study Officials

  • Frederick Ueland, MD

    Markey Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 29, 2020

Study Start

March 17, 2021

Primary Completion

May 17, 2024

Study Completion

May 17, 2024

Last Updated

June 29, 2025

Results First Posted

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)