Neoplasms, Breast Clinical Trial
Official title:
Phase I Study of Lapatinib in Combination With Trastuzumab
Verified date | August 2018 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | December 10, 2007 |
Est. primary completion date | December 10, 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 74 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Japan | GSK Investigational Site | Saitama | |
Japan | GSK Investigational Site | Tokyo |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly | 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. | 6 Months | |
Secondary | 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 | 6 Months |
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