GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Neoplasms, Breast

Treatments: Drug: GW572016 oral tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00371488

EGF105635

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

GW572016 in combination with trastuzumab

Experimental group

Description:

Lapatinib: 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: 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.

Treatment:

Drug: GW572016 oral tablets