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

Sponsor
NCIC Clinical Trials Group
Study ID
NCT01138384
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Foretinib — DRUG
    Daily oral dosing at assigned dose beginning day 3 of cycle 1
  • Lapatinib — DRUG
    Daily oral dosing at assigned dose beginning day 1 cycle 1.

Study Details

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.

Key Dates

Start date
Oct 27, 2010
Status verified
Apr 2020
Primary completion
May 14, 2014
Completion
Feb 13, 2015

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Toxicity, maximum administered dose and the recommended phase II dose [ Time Frame: every 4 weeks ]

Related Studies