Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer

Completed · Phase 1

Conditions studied: Ovarian Cancer

In brief

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 facts

Study ID

NCT04608409

Run by

Frederick R. Ueland, M.D.

People needed

16

Starts

2021-03-17

Expected to finish

2024-05-17

Last updated by the study team

2025-06-29

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Markey Cancer Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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