A Study of Foretinib in Patients With Recurrent/Metastatic Breast Cancer

NCT01147484 | Completed Phase 2 DMC

• 1 other identifier: I197
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to find out what effects this new drug foretinib has on this type of breast cancer, called "triple negative" breast cancer because the cancer tissue is estrogen, progesterone and HER2 receptor negative.

Conditions

Recurrent Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response and early progression rate

  All patients will be assessed for response at the end of every second cycle (every 8 weeks). Response and progression will be evaluated using RECIST 1.1.

  Every 8 weeks

Secondary Outcomes (3)

• Adverse Events as a Measure of Safety and Tolerability

  every 4 weeks

• Relationship between response and biomarkers

  2 years (end of study)

• Biomarkers in Tumour cells

  2 years (end of study)

Study Arms (1)

Foretinib

EXPERIMENTAL

Drug: Foretinib

Interventions

Foretinib DRUG

foretinib, at a continuous oral daily dose of 60 mg

Foretinib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of invasive breast cancer, that is estrogen receptor (ER) negative, progesterone receptor (PR) negative and human epidermal growth factor receptor 2 (HER2) negative.
• Formalin fixed paraffin embedded tissue available for central pathology review and translational studies. Patients entered on the second stage of accrual must have an accessible tumour lesion for biopsy.
• Advanced or recurrent/ metastatic disease incurable with standard therapies.
• Clinically and/or radiologically documented measurable disease. At least one site of disease must be unidimensionally measurable.
• ECOG performance of 0, 1 or 2.
• Age ≥ 18 years of age.
• Previous Therapy: Any treatment-related major organ toxicities must be recovered to ≤ grade 1.
• Patients may have received adjuvant chemotherapy and/or one prior line of chemotherapy in the recurrent/metastatic setting. A minimum of 21 days since the last dose of chemotherapy must have elapsed prior to registration.
• No prior therapy with a c-Met inhibitor or angiogenesis inhibitor. Other targeted agents are permissible provided a minimum of 21 days has elapsed since last day of targeted therapy and registration.
• Prior radiation therapy permitted 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. Exceptions may be made for non-myelosuppressive radiation to peripheral areas.
• Previous surgery permitted provided wound healing has occurred and at least 14 days have elapsed 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; ALT and AST ≤ 2 x UNL
• 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

You may not qualify if:

• History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
• Resting BP consistently higher than systolic \> 150 mmHg and/or diastolic \> 100 mmHg (in the presence or absence of a stable dose of anti-hypertensive medication) or poorly controlled hypertension, history of labile hypertension or poor compliance with anti-hypertensive medication.
• Appreciable cavitating or actively bleeding lesions.
• Untreated brain or meningeal metastases. (Patients with neurologically stable and treated brain metastases who have discontinued corticosteroids at least two weeks prior to study registration and have no evidence of cavitation or hemorrhage are eligible).
• Untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction. Patients with a significant cardiac history (even if controlled) or prior anthracycline exposure are required to have an LVEF \> 50%.
• GI tract disease resulting in an inability to absorb oral medication.
• Active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
• Known hypersensitivity to the study drugs or their components.
• Potent CYP3A4 inhibitors/inducers (e.g. ketoconazole, carbamazepine) must be discontinued at least 7 days prior to Day 1, Cycle 1.
• Treatment, concurrent or within 3 weeks prior to registration, with other investigational drugs or anti-cancer therapy.
• Proliferative diabetic retinopathy, retinal arteritis or hemorrhage.
• History of pulmonary embolus or a deep vein thrombosis diagnosed and/or treated within 6 months prior to registration.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• GlaxoSmithKline: collaborator

Study Sites (9)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Hopital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

• Rayson D, Lupichuk S, Potvin K, Dent S, Shenkier T, Dhesy-Thind S, Ellard SL, Prady C, Salim M, Farmer P, Allo G, Tsao MS, Allan A, Ludkovski O, Bonomi M, Tu D, Hagerman L, Goodwin R, Eisenhauer E, Bradbury P. Canadian Cancer Trials Group IND197: a phase II study of foretinib in patients with estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2-negative recurrent or metastatic breast cancer. Breast Cancer Res Treat. 2016 May;157(1):109-16. doi: 10.1007/s10549-016-3812-1. Epub 2016 Apr 26.

  PMID: 27116183 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

GSK 1363089

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sasha Lupichuk

  Tom Baker Cancer Centre, Calgary AB

  STUDY CHAIR

• Daniel Rayson

  QEII HSC - Nova Scotia Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: June 22, 2010
• Study Start: September 2, 2010
• Primary Completion: December 14, 2014
• Study Completion: February 13, 2015
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9)