Study of Foretinib in Combination With Lapatinib in Patients With Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
NCIC Clinical Trials Group
First received: June 4, 2010
Last updated: August 8, 2013
Last verified: August 2013
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 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 1
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically confirmed diagnosis of invasive breast cancer, that is human epidermal growth factor receptor 2 (HER2) positive assessed by FISH or IHC 3+ staining (in accordance with ASCO guidelines) on the basis of the local evaluation of HER2 status.
- Formalin fixed paraffin embedded tissue available for translational studies. Patients entered on the expanded RP2D cohort must have an accessible tumour lesion for biopsy.
- Advanced or recurrent/ metastatic disease incurable with standard therapies.
- During the dose escalation phase patients are not required to have measurable disease, but if they do, it will be recorded and followed. Patients at the expanded RP2D must have measurable disease defined by the RECIST 1.1.
- ECOG performance status 0, 1 or 2.
- Age ≥ 18 years of age.
- Any treatment-related major organ toxicities must be recovered to ≤ grade 1.
- Patients may have had prior chemotherapy for adjuvant and/or for metastatic disease. There is no limit to the number of previous chemotherapy regimens allowed provided patients meet other eligibility criteria. A minimum of 21 days since the last dose of chemotherapy must have elapsed prior to registration.
- Patients may have had prior hormone therapy. There is no limit to the number of previous hormone regimens allowed provided patients meet other eligibility criteria. A minimum of 7 days since the last dose of hormone therapy must have elapsed prior to registration.
- Patients may have had prior therapy with trastuzumab or lapatinib. No prior therapy with a c-Met inhibitor or angiogenesis inhibitor. Other targeted agents permissible provided a minimum of 21 days has elapsed since last day of targeted therapy and registration.
- Patients may have had prior radiation therapy provided the patient has recovered from acute toxic effects of the radiation therapy prior to registration and at least 21 days have elapsed from the day of the last fraction of radiation to the date of registration.
- Previous surgery is permitted provided that wound healing has occurred and at least 14 days have elapsed prior to registration if surgery was major.
- Granulocytes (AGC) ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L
- Serum creatinine ≤ 1.2 x UNL; Total bilirubin ≤ 1.2 x UNL; AST and ALT ≤ 2 x UNL; Potassium within normal range; Magnesium within normal range
- Left ventricular ejection fraction ≥ 50% demonstrated by MUGA scan or echocardiogram within 28 days prior to registration.
- Women must be post menopausal, surgically sterile or use a reliable form of contraception while on study and for 90 days after discontinuing therapy. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to registration and must not be lactating.
- Patients who require oral anticoagulants (coumadin, warfarin) are eligible
- Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements.
- Protocol treatment must begin within 2 working days of patient registration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138384
|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 |
NCIC Clinical Trials Group
||British Columbia Cancer Agency
No publications provided
||NCIC Clinical Trials Group
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 4, 2010
||August 8, 2013
||Canada: Health Canada
Keywords provided by NCIC Clinical Trials Group:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2013
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Molecular Mechanisms of Pharmacological Action