Trials / Completed
CompletedNCT00650910
Study To Examine The Effects Of Lapatinib On The Pharmacokinetics Of Digoxin In Subjects w/ ErbB2 Positive Breast Cancer
An Open-Label, Two-Part, Single Sequence Study to Examine the Effects of Lapatinib on the Pharmacokinetics of Orally Administered Digoxin in Subjects With Metastatic ErbB2 Positive Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a two part study looking at the effect of lapatinib on concentrations of digoxin in the blood when both drugs are dosed together in Part 1; and looking at the safety and antitumor effect of lapatinib when used together with possible additional anticancer therapy as chosen at the doctor's discretion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lapatinib | 1500 mg oral lapatinib starting Day 2 continuing through Day 9. Part 2 subjects received 1500mg daily through week 10. |
| DRUG | Digoxin | 0.5mg on Days 1 and 9 |
Timeline
- Start date
- 2008-04-23
- Primary completion
- 2009-07-10
- Completion
- 2009-07-10
- First posted
- 2008-04-02
- Last updated
- 2017-11-17
Locations
4 sites across 3 countries: United States, Canada, South Korea
Source: ClinicalTrials.gov record NCT00650910. Inclusion in this directory is not an endorsement.