A Study of Foretinib in Patients With Recurrent/Metastatic Breast Cancer (IND197)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01147484
First received: May 27, 2010
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Recurrent Breast Cancer
Drug: Foretinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Foretinib in Patients With Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) Negative, Recurrent/Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Objective response and early progression rate [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adverse Events as a Measure of Safety and Tolerability [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
    All patients will be assessed for toxicity at the end of every cycle (every 4 weeks). Adverse events will be graded using CTCAE V4.0.

  • Relationship between response and biomarkers [ Time Frame: 2 years (end of study) ] [ Designated as safety issue: No ]
    Archival tissue will be collected on all patients. Pre-treatment fresh tissue biopsies CTC's will be collected on all patients entered in the second stage of accrual. Translational research studies will be done as described in protocol section 17.0.

  • Biomarkers in Tumour cells [ Time Frame: 2 years (end of study) ] [ Designated as safety issue: No ]
    Archival tissue will be collected on all patients. Pre-treatment fresh tissue biopsies CTC's will be collected on all patients entered in the second stage of accrual. Translational research studies will be done as described in protocol section 17.0.


Enrollment: 47
Study Start Date: May 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Foretinib Drug: Foretinib
foretinib, at a continuous oral daily dose of 60 mg

Detailed Description:

This research is being done because there is no treatment that will cure this type of cancer. Although some types of chemotherapy can cause this cancer to shrink for a time, better options are needed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements.
  • Protocol treatment must begin within 7 working days of patient registration.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147484

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
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
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Ottawa Health Research Institute - General Division
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Sasha Lupichuk Tom Baker Cancer Centre, Calgary AB
Study Chair: Daniel Rayson QEII HSC - Nova Scotia Cancer Centre
  More Information

Additional Information:
No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01147484     History of Changes
Other Study ID Numbers: I197
Study First Received: May 27, 2010
Last Updated: February 7, 2014
Health Authority: Canada: Health Canada

Keywords provided by NCIC Clinical Trials Group:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014