Journal
CANCER CHEMOTHERAPY AND PHARMACOLOGY
Volume 84, Issue 5, Pages 1145-1151Publisher
SPRINGER
DOI: 10.1007/s00280-019-03947-7
Keywords
Bortezomib; Lapatinib; Phase I; EGFR; HER2; Proteasome inhibitor
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Funding
- Ruesch Center for the Cure of Gastrointestinal Cancers
- National Cancer Institute [P30CA051008]
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PurposeThis phase I trial evaluated the maximum tolerated dose, safety and preliminary efficacy of lapatinib, a HER1, HER2 dual kinase inhibitor plus bortezomib, a proteasome inhibitor, in adult patients with advanced malignancies.MethodsPatients were enrolled in a standard 3+3 design with lapatinib (L) 750, 1000, 1250 or 1500 mg daily, and bortezomib (B) 0.7, 1.0, 1.3 or 1.6 mg/m(2) for 3 weeks with 1 week off. Dose-limiting toxicities (DLT) were assessed during the first 28 daysResultsFifteen patients received the combination of lapatinib and bortezomib in three different cohorts and ten were evaluable for DLT. There were no DLTs. Anorexia was the most common adverse event. Biomarker analysis showed upregulation of p27 expression with lapatinib and the combination. No tumor response was observed and thus the study was closed early.ConclusionThe combination of lapatinib and bortezomib was well tolerated but no complete or partial tumor responses were observed at the dose levels tested.ClinicalTrials.gov IdentifierNCT01497626.
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