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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00650910 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic ErbB2 Neoplasms, Breast Breast Cancer |
Drug: lapatinib Drug: Digoxin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 17 |
| Study Start Date: | April 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: lapatinib + digoxin
All subjects received 0.5mg digoxin on Days 1 and 9 with daily dosing of 1500mg oral lapatinib starting on Day 2 and continuing through Day 9. Subjects could continue past Day 9 on daily oral lapatinib until Week 10 when they could transfer into a rollover study (EGF19060 or EGF111767).
|
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
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A female is eligible to enter and participate in the study if she is of:
- Non-childbearing potential (i.e. physiologically incapable of becoming pregnant), including any female who:
Is post-menopausal (a demonstration of total cessation of menses for ≥ 1 year) or
- Childbearing potential, has a negative serum pregnancy test at Screening and agrees to one of the following:
Exclusion Criteria:
Contacts and Locations| United States, New Mexico | |
| GSK Investigational Site | |
| Albuquerque, New Mexico, United States, 87131 | |
| Canada, Alberta | |
| GSK Investigational Site | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Korea, Republic of | |
| GSK Investigational Site | |
| seodaemun-gu, Seoul, Korea, Republic of, 120-752 | |
| GSK Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00650910 History of Changes |
| Other Study ID Numbers: | EGF110557 |
| Study First Received: | March 28, 2008 |
| Last Updated: | August 18, 2011 |
| Health Authority: | United States: Food and Drug Administration; Korea: Food and Drug Administration; Canada: Health Canada |
|
lapatinib Metastatic ErbB2 positive breast cancer digoxin |
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Digoxin Lapatinib Cardiotonic Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Protective Agents Physiological Effects of Drugs Protein Kinase Inhibitors Antineoplastic Agents |