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A Phase I/II Trial of TKI258 (Dovitinib) in Combination With an Aromatase Inhibitor in Patients With Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Phase I/II Trial of TKI258 (Dovitinib) in Combination With an Aromatase Inhibitor in Patients With Metastatic Breast Cancer


This is a Phase I/Phase II open-label single arm trial of dovitinib in combination with
anastrozole 1 mg daily, exemestane 25 mg daily, or letrozole 2.5 mg daily. Study subjects
will receive the aromatase inhibitor on which they had previously derived clinical benefit.


Inclusion Criteria:



- Female patients with breast cancer either in the primary or metastatic setting

- Tumor must be estrogen receptor and/or progesterone receptor positive and Her-2
negative

- Evidence of disease resistance to an aromatase inhibitor

- ECOG performance status 0 or 1

- Age 18 years or older

- Adequate laboratory values

- Able to give written informed consent

- Measurable disease

- No more than 2 prior chemotherapy regimens in the metastatic setting

- Unlimited prior hormonal therapy in the metastatic setting

- Life expectancy of greater than 3 months

- Post-menopausal

- Tumor must be available for central testing for FGFR1 amplification by FISH/CISH

Exclusion Criteria:

- Brain metastases

- Another primary malignancy within 3 years prior to starting drug therapy with the
exception of adequately treated in-site carcinoma of the uterine cervix or skin
cancer

- Chemotherapy within 3 weeks prior to starting study drug or not recovered from side
effects of previous therapy

- Administration of nitrosurea or mitomycin-C within 6 weeks prior to starting study
drug or not recovered from side effects of such therapy

- Administration of biologic therapy within 6 weeks prior to starting study drug or not
recovered from side effects of such therapy

- Radiotherapy within 4 weeks prior to starting study drug or 2 weeks in the case of
localized radiotherapy or not recovered from radiotherapy toxicities

- major surgery, open biopsy or significant traumatic injury within 4 weeks prior to
starting study drug or a minor procedure, percutaneous biopsy or placement of a
vascular access device within 1 week prior to starting study drug or not recovered
from side effects of such procedure or injury

- Chronic concomitant bisphosphonate therapy for the prevention of bone metastases.
Bisphosphonate/ denosumab therapy for the management of bone metastases or for the
treatment of osteoporosis s allowed.

- Impaired cardiac function or clinically significant cardiac disease

- Impairment of GI function or GI disease that may significantly alter the absorption
of dovitinib

- Cirrhosis, chronic active hepatitis, or chronic persistent hepatitis

- Known diagnosis of HIV infection

- Anticoagulation treatment with therapeutic doses of warfarin

- Any concurrent severe and/or uncontrolled concomitant medical condition that could
cause unacceptable safety risks or compromise compliance with the protocol

- Pregnant or breast-feeding

- Unwilling or unable to comply with the protocol

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Benefit Rate

Outcome Description:

Complete response, partial response, or stable disease at 24 weeks from trial entry as defined by RECIST 1.1 criteria

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Claudine Isaacs, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University

Authority:

United States: Food and Drug Administration

Study ID:

LCCC 2010-535

NCT ID:

NCT01484041

Start Date:

April 2012

Completion Date:

December 2016

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • postmenopausal
  • Breast Neoplasms

Name

Location

Georgetown Lombardi Comprehensive Cancer Center Washington, District of Columbia  20007