Study of Foretinib in Combination With Lapatinib in Patients With Metastatic Breast Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Toxicity, maximum administered dose and the recommended phase II dose [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]Adverse events will be graded using CTCAE V4.0
- Pharmacokinetic evaluation of lapatinib [ Time Frame: cycle 1 only ] [ Designated as safety issue: No ]pharmacokinetic evaluation of lapatinib when administered in combination with foretinib
- Preliminary evidence of efficacy [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]All patients with measurable disease will be evaluated for response and progression using RECIST 1.1.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Foretinib and Lapatinib
Patients will receive foretinib as a continuous oral dose, and lapatinib as a continuous oral dose. Lapatinib will commence on Day1, Cycle 1 and foretinib will commence on Day 3, Cycle 1.
Daily oral dosing at assigned dose beginning day 3 of cycle 1Drug: Lapatinib
Daily oral dosing at assigned dose beginning day 1 cycle 1.
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.
|Canada, British Columbia|
|BCCA - Cancer Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Cancer Centre of Southeastern Ontario at Kingston|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|McGill University - Dept. Oncology|
|Montreal, Quebec, Canada, H2W 1S6|
|Study Chair:||Stephen Chia||British Columbia Cancer Agency|