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Phase I/II Clinical Study of GW572016 (Lapatinib Ditosylate Monohydrate) in Combination With Trastuzumab in Patients With Breast Cancer Previously Treated With Trastuzumab


Phase 1
20 Years
74 Years
Not Enrolling
Both
Neoplasms, Breast

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Trial Information

Phase I/II Clinical Study of GW572016 (Lapatinib Ditosylate Monohydrate) in Combination With Trastuzumab in Patients With Breast Cancer Previously Treated With Trastuzumab

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly

Outcome Description:

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.

Outcome Time Frame:

6 Months

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

EGF105635

NCT ID:

NCT00371488

Start Date:

April 2006

Completion Date:

December 2007

Related Keywords:

  • Neoplasms, Breast
  • ErbB2
  • Stage IV breast cancer
  • ErbB1
  • breast cancer
  • lapatinib
  • Herceptin
  • trastuzumab
  • Breast Neoplasms
  • Neoplasms

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