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NCT04608409CompletedPhase 1

Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer

A Phase I Dose-Escalation Study on the Safety of Lapatinib With Dose-Dense Paclitaxel in Patients With Platinum-Resistant Ovarian Cancer

Source: ClinicalTrials.gov · Last updated 29 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
16 (actual)
First submitted
22 Oct 2020
Start date
17 Mar 2021
Primary completion date
17 May 2024
Lead sponsor
Frederick R. Ueland, M.D.
NCT number
NCT04608409

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 16
  • From 17 Mar 2021 to the primary completion date, 17 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • receiving medications that inhibit or induce CYP3A4
  • receiving any other anti-cancer investigational agents

Other illness

  • hypersensitivity to lapatinib or paclitaxel
  • uncontrolled intercurrent illness
  • malabsorption syndrome
  • congestive heart failure

Other

  • baseline neuropathy greater than Grade 1

Who the study is looking for

  • 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

Age in the registry: 18 years to 100 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Markey Cancer Center
Coordinator of this site? Confirm its status
LexingtonUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.