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Clinical trial

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

ID
Name
MCC-20-GYN-06
Description
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.
Trial arms
Trial start
2021-03-17
Estimated PCD
2025-06-30
Trial end
2025-06-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Lapatinib and Paclitaxel
Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
Arms:
Lapatinib - Group 1, Lapatinib - Group 2, Lapatinib - Group 3, Lapatinib - Group 4
Size
15
Primary endpoint
Progression-free survival.
One year
Dose-limiting toxicity
4 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}
Updated at
2024-03-01

1 organization

1 product

1 indication

Organization
Frederick R. Ueland
Product
Lapatinib and Paclitaxel
Indication
Ovarian Cancer