GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00371488|
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms, Breast||Drug: GW572016 oral tablets||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Lapatinib in Combination With Trastuzumab|
|Actual Study Start Date :||April 6, 2006|
|Actual Primary Completion Date :||December 10, 2007|
|Actual Study Completion Date :||December 10, 2007|
Experimental: GW572016 in combination with trastuzumab
A specified dose of lapatinib will be orally taken once daily, at least one hour before or one hour after the morning meal. Lapatinib should be taken at the same time of day wherever possible.
The starting dose of lapatinib should be 750 mg/day, which will be increased to 1000 mg/day (dose escalation group) according to the dose escalation criteria.
Trastuzumab (4 mg/kg/day in the first week and 2 mg/kg/day for the 2nd and subsequent weeks) will be administered by intravenous infusion over at least 90 minutes immediately after administration of lapatinib. The fifth (Day 36) and subsequent doses may be administered up to 3 days after the scheduled date. In this case, however, the all following doses should be administered at one-week intervals.
Drug: GW572016 oral tablets
Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets.
- Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly [ Time Frame: 6 Months ]To confirm the safety and tolerability of the recommended dose of lapatinib in combination with trastuzumab which was determined in a preceding overseas study, and to determine the recommended dose in Japan.
- 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 [ Time Frame: 6 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371488
|GSK Investigational Site|
|Saitama, Japan, 350-1298|
|GSK Investigational Site|
|Tokyo, Japan, 135-8550|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|