EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer



Status:Approved for marketing
Conditions:Breast Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2006
End Date:March 2015

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An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects With ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer

This study will provide pre-approval drug access to lapatinib, in combination with
capecitabine, to patients whose breast cancer had progressed on other therapies


Inclusion criteria:

- May have received prior lapatinib in another trial. Previous capecitabine (as
previous agent or non-lapatinib containing regimen) is also permitted.

- Prior treatment with hormonal therapy is allowed.

- Must have advanced or metastatic breast cancer with progression (as assessed by
modified RECIST) after prior therapy, which must include all of the following: prior
treatment with an anthracycline, a taxane, and trastuzumab alone or in combination
with other therapy. Trastuzumab must have been administered in the adjuvant, or
locally advanced or metastatic setting.

- Must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for
ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to
study entry.

- Must be >/= 18 years of age

- Life expectancy of > 8 weeks

- Must have recovered from side effects of previous treatment

- Patients with CNS mets are eligible provided treatment with prohibited medications as
listed in the protocol are not required

- Cardiac ejection fraction must be within the institutional range of normal as
measured by ECHO. MUGA scans are allowed if ECHOs cannot be performed

- Able to swallow and retain oral medications

- Must have adequate hematologic, hepatic and renal function

Exclusion criteria:

- Pregnant or lactating females

- Malabsorption syndrome, disease significantly affecting GI function, or resection of
the stomach or bowel, or ulcerative colitis

- Concurrent disease or condition that would make the patient inappropriate for study
participation

- Unresolved or unstable toxicity from prior administration of another investigational
drug and/or prior cancer treatment

- Uncontrolled infection

- Active cardiac disease defined as history of uncontrolled or symptomatic angina;
history of arrhythmias requiring medication, or clinically significant, with the
exception of asymptomatic atrial fibrillation requiring anticoagulation; MI < 6
months from study entry; uncontrolled or symptomatic CHF; ejection fraction below the
institutional normal limit; any other cardiac condition that would make this protocol
unreasonably hazardous for the patient

- Receiving concurrent chemotherapy (other than capecitabine), radiation therapy,
immunotherapy, biologic therapy or hormonal therapy for cancer. Concurrent therapy
with bisphosphonates is allowed

- History of allergic reaction attributed to compounds of similar composition to
lapatinib or any excipients

- History of allergic reactions attributed to compounds of similar chemical composition
to capecitabine, fluorouracil or excipients

- Known DPD deficiency
We found this trial at
139
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Newport Beach, California 92663
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Anchorage, Alaska 99508
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Ann Arbor, Michigan 48109
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Arlington, Texas 76012
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Augusta, Georgia 30904
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Austin, Texas 78759
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Baltimore, Maryland 21287
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Baton Rouge, Louisiana 70808
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Bellflower, California 90706
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Bettendorf, Iowa 52722
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Billings, Montana 59102
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Bismarck, North Dakota 58501
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Boise, Idaho 83712
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Boston, Massachusetts 02118
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Boulder, Colorado 80304
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Brunswick, Georgia 31525
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Buffalo, New York 14215
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Burbank, California 91505
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Cedar Rapids, Iowa 52401
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Charleston, South Carolina 29407
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Charlotte, North Carolina 28277
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Chevy Chase, Maryland 20815
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Chicago, Illinois 60612
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Cincinnati, Ohio 45229
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Cleveland, Ohio 44109
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Columbia, Missouri 65212
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Columbia, South Carolina 29201
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Columbus, Ohio 43205
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Council Bluffs, Iowa 51503
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Dallas, Texas 75216
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Decatur, Illinois 62526
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Detroit, Michigan 48202
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Drexel Hill, Pennsylvania 19026
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Duluth, Minnesota 55805
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East Setauket, New York 11733
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El Paso, Texas 79902
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Exeter, New Hampshire 03833
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Fairfax, Virginia 22031
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Fort Lauderdale, Florida 33313
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Frederick, Maryland 21702
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Freehold, New Jersey 07728
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Fresh Meadows, New York 11366
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Galesburg, Illinois 61401
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Greensboro, North Carolina 27401
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Joliet, Illinois 60435
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Kennewick, Washington 99336
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Klamath Falls, Oregon 97601
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Knoxville, Tennessee 37934
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Kogarah, New South Wales 2217
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Mt. Pleasant, South Carolina 29464
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New Havey, Connecticut 06511
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230 Park Avenue, 21st Floor
New York, New York 10169
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Newark, New Jersey 07103
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