NCT01138384

Study of Foretinib in Combination With Lapatinib in Patients With Metastatic Breast Cancer

A Phase I/II Study of Foretinib in Combination With Lapatinib in Patients With Human Epidermal Growth Factor Receptor 2(HER2)Over-Expressing Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done because it is not yet known what dose of foretinib in combination with lapatinib can be given safely to patients with breast cancer, nor what type and severity of side effects will result from the combination of the two treatments. This research is also being done because it is not clear if the addition of the new drug foretinib to treatment with lapatinib can offer better results and longer survival than treatment with lapatinib alone.

Detailed description

The purpose of this study is to find the dose of foretinib that can safely be given in combination with lapatinib. This is done by starting at doses of both drugs lower than the usual doses of each when given on their own. Patients are given foretinib and lapatinib and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more patients are asked to join the study and are given higher does of foretinib and lapatinib. Patients joining the study later on will get higher doses of foretinib and lapatinib than patients who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Foretinib	Daily oral dosing at assigned dose beginning day 3 of cycle 1
DRUG	Lapatinib	Daily oral dosing at assigned dose beginning day 1 cycle 1.

Timeline

• Start date: 2010-10-27
• Primary completion: 2014-05-14
• Completion: 2015-02-13
• First posted: 2010-06-07
• Last updated: 2023-08-04

Locations

5 sites across 1 country: Canada