A phase I study of high-dose rosuvastatin with standard dose erlotinib in patients with advanced solid malignancies.

ABSTRACT:

Background

Synergistic cytotoxicity with high-dose statins and erlotinib has been demonstrated in preclinical models across a number of tumour types. In this phase I study, we evaluated the safety and potential anti-tumour activity of escalating doses of rosuvastatin in combination with the standard clinical dose of erlotinib in heavily pretreated patients with advanced solid tumours.

Methods

This was a single-center, phase I open-label study to determine the safety and recommended phase two dose (RPTD) of rosuvastatin in combination with 150 mg/day standard dose of erlotinib. Using a 3 + 3 study design and 28-day cycle, escalating doses of rosuvastatin from 1 to 8 mg/kg/day × 2 weeks (cycle 1) and 3 weeks (subsequent cycles) given concurrently with erlotinib were evaluated.

SUBMITTER: Goss GD 

PROVIDER: S-EPMC4815068 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature