Last updated: 11/04/2018 06:27:22
GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Phase I study of lapatinib in combination with trastuzumab
Trial description: This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly
Timeframe: 6 Months
Secondary outcomes:
Clinical benefit Time to tumor response Length of response Time to progression of cancer 6 month progression free survival Overall survival as well as specific biomarkers in tumor tissue
Timeframe: 6 Months
Interventions:
Drug: GW572016 oral tablets
Enrollment:
11
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
April 2006 to December 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
20 - 74 years
Accepts healthy volunteers
No
- Patients with confirmed breast cancer who have received prior trastuzumab.
- Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
- Patients with certain heart problems.
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with confirmed breast cancer who have received prior trastuzumab.
- Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
- Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
Exclusion criteria:
- Patients with certain heart problems.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-10-12
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
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Additional information
Results for study EGF105635 can be found on the GSK Clinical Study Register.
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