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A Study to Assess the Effect of Food on the Bioavailability of the IGF-1R Inhibitor AXL1717 in Patients With Advanced Malignant Tumors

Solid Tumors Clinical Trial

Official title:
A Randomized, Open-label, Phase I, Crossover Study to Assess the Effect of Food on the Bioavailability of AXL1717, in Patients With Advanced Malignant Tumors

Clinical Trial Summary

This is a prospective, randomized, open-label, Phase I, crossover study to assess the effect of food on the bioavailability of AXL1717 including patients with advanced malignant tumors

Clinical Trial Description

This is a randomized, crossover, open label, phase I study to assess the effect of food on the bioavailability of AXL1717 in advanced cancer patients.

A single, oral dose of AXL1717 is to be administered to patients on each of two occasions that are 7-day apart, in random order: after an overnight fast (fasted treatment) and with a high-fat or moderate-fat breakfast (fed treatment). ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01725555
Study type Interventional
Source Axelar AB
Contact
Status Completed
Phase Phase 1
Start date October 2012
Completion date December 2013
View Details
See also
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