Status:
APPROVED_FOR_MARKETING
EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer
Lead Sponsor:
Novartis
Conditions:
Neoplasms, Breast
Eligibility:
All Genders
18+ years
Brief Summary
This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
EXPANDED_ACCESS
End Date :
March 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00338247
Start Date
July 1 2006
End Date
March 1 2015
Last Update
April 6 2016
Active Locations (453)
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1
Novartis Investigative Site
Huntsville, Alabama, United States, 35805
2
Novartis Investigative Site
Anchorage, Alaska, United States, 99508
3
Novartis Investigative Site
Glendale, Arizona, United States, 85304
4
Novartis Investigative Site
Fayetteville, Arkansas, United States, 72703