Phase 1
Completed N=16
Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer
Ovarian Cancer
Source: ClinicalTrials.gov NCT04608409 ↗
Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Jun 2025
Primary outcomePrimary: Progression-free Survival. — 0; 0; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival. |
0; 0; 1 | — |
| PRIMARY Number of Participants With Dose-limiting Toxicity |
0; 1; 1 | — |
| SECONDARY Change in Plasma Concentration of Lapatinib Cycle 1 |
2579; 1593; 2490; 1630; 2370; 2851 | — |
| SECONDARY Change in Plasma Concentration of Lapatinib Cycle 2 |
2002; 2987; 2951; 2002; 3393; 2312 | — |
| SECONDARY Change in Plasma Concentration of Lapatinib Cycle 3 |
1439; 1499; 2175; 2242; 1031; 1824 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04608409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.