To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Midazolam — DRUG
  Subjects will receive midazolam by oral or IV route on Days 1, 3, 9 and 11. Oral midazolam was supplied as 3 mg tablets; IV midazolam was supplied as 1 milligram per milliliter (mg/L) sterile solution.
• Lapatinib — DRUG
  Subjects will receive 1500 mg lapatinib by oral route once daily from Day 4.

Study Details

To characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics of a single oral and single intravenous dose of midazolam in adult cancer patients. Also to assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients.

Key Dates

Start date

Nov 21, 2005

Status verified

Dec 2017

Primary completion

Feb 8, 2007

Completion

Feb 8, 2007

Study Design

Enrollment

24 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Subjects with cancer
  In Part 1 of the study, subjects will be randomized to one of four sequences. All subjects will receive oral or intravenous (IV) midazolam on Days 1, 3, 9 and 11 as per assigned randomization scheme. Starting on Day 4 through Day 11, subjects will receive a daily dose of 1500 milligrams (mg) of oral lapatinib. In Part 2, which will begin on Day 12, the subjects will be required to take 1500 mg of lapatinib daily until removed from the study for disease progression, adverse events, withdrawal of consent, or transfer to another lapatinib study.

Primary Outcome Measure

Area under the concentration versus time curve (AUC) of midazolam [ Time Frame: Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11 ]

Locations (2)

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