Clinical trial · Interventional
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
NCT04608409CI-TRIAL-00091539completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lapatinib and Paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Lapatinib - Group 1
- description
- Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
- interventionNames
- Drug: Lapatinib and Paclitaxel
- type
- EXPERIMENTAL
- label
- Lapatinib - Group 2
- description
- Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
- interventionNames
- Drug: Lapatinib and Paclitaxel
- type
- EXPERIMENTAL
- label
- Lapatinib - Group 3
- description
- Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCao CD, McCorkle JR, Yan D, Esfahani HS, Jayswal R, Piecoro D, Li N, Baldwin LA, Miller RW, Desimone CP, Dietrich CS, Ueland FR, Kolesar JM. A Phase 1 Dose Escalation of Lapatinib and Paclitaxel in Recurrent Ovarian Cancer. Cancers (Basel). 2026 Feb 14;18(4):626. doi: 10.3390/cancers18040626. PMID 41749879