Study To Examine The Effects Of Lapatinib On The Pharmacokinetics Of Digoxin In Subjects w/ ErbB2 Positive Breast Cancer

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• lapatinib — DRUG
  1500 mg oral lapatinib starting Day 2 continuing through Day 9. Part 2 subjects received 1500mg daily through week 10.
• Digoxin — DRUG
  0.5mg on Days 1 and 9

Study Details

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.

Key Dates

Start date

Apr 23, 2008

Status verified

Nov 2017

Primary completion

Jul 10, 2009

Completion

Jul 10, 2009

Study Design

Enrollment

17 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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).

Primary Outcome Measure

To characterize the effect of repeat oral dose lapatinib treatment on the pharmacokinetics of a single oral dose of digoxin in adult subjects with metastatic ErbB2 positive breast cancer. [ Time Frame: 10 days ]

Locations (1)

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