Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Frederick R. Ueland, M.D.
Study ID
NCT04608409
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 17, 2021
Status verified
Jun 2025
Primary completion
May 17, 2024
Completion
May 17, 2024

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib - Group 1
    Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
  • Experimental: Lapatinib - Group 2
    Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
  • Experimental: Lapatinib - Group 3
    Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).

Primary Outcome Measure

Progression-free Survival. [ Time Frame: One year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Markey Cancer CenterLexingtonKentucky40536-

Find similar trials in Lexington, KY

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Markey Cancer Center· Lexington, KY

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