Last updated: 11/04/2018 06:24:52
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer
GSK study ID
EGF103659
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects with ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer
Trial description: This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
To offer pre-approval drug access to lapatinib, in combination with capecitabine, in order to provide potential clinical benefit to patients with ErbB2 overexpressing breast cancer.
Timeframe: 81 months
Secondary outcomes:
Overall survival
Timeframe: 81 months
Relationship between genetic variants in candidate genes and the safety and/or efficacy of lapatinib in combination with capecitabine
Timeframe: 281 months
progression-free survival
Timeframe: 81 months
serious adverse events (SAEs)
Timeframe: 81 months
Interventions:
Enrollment:
4732
Primary completion date:
2015-31-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
July 2006 to February 2016
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- 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.
- Pregnant or lactating females
- Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or bowel, or ulcerative colitis
Inclusion and exclusion criteria
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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
No longer a GSK study
Actual primary completion date
2015-31-03
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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