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Lapatinib in ERBB4-Mutated Stage IV Melanoma
NCT01264081Phase 2
Key facts
- Status
- Terminated
- Start
- May 2011
- Primary completion
- Nov 2013
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Small Molecules
- Drugs
- lapatinib
- Conditions
- melanoma
01
Overview
Phase 2, open-label, single-arm trial of lapatinib in melanoma, sponsored by National Cancer Institute. Primary endpoint: Partial Response (PR) and Complete Response (CR) Rate at 3 years. Started May 2011; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Lapatinib
Lapatinib 500 mg PO BID
03
Who it enrols
Adult patients with stage IV melanoma harboring <= 2 ERBB4 mutations who have failed standard therapy and have adequate organ function.
04
Endpoints
Primary
Partial Response (PR) and Complete Response (CR) Rate
Secondary
Progression Free Survival
Number of Participants With Serious and Non-Serious Adverse Events
Pharmacokinetics of Lapatinib
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