A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib

ClinicalTrials.gov ID: NCT00996762

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Official title

An Open-label, Randomized, Adaptive Design, Two-period Crossover Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib Compared to the Commercial Tablet

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will assess alternative formulations of lapatinib for relative bioavailability and bioequivalence (BE) with the current commercial formulation (reference). Subjects will be dosed for at least one week (7 days) on each formulation and PK samples will be collected after each lapatinib formulation dosing Period on Period 1 Day 7 and Period 2 Day7 at pre-dose and up to 24 hrs post dose. The study may evaluate up to three alternative test formulations. After subjects complete the PK evaluation at the End of Study Visit, if they are eligible, they will have the option to enter EGF111767, an open-label, Phase Ib continuation study of lapatinib monotherapy or lapatinib in combination with other anti-cancer treatments.

Study identification

NCT ID: NCT00996762
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: GlaxoSmithKline; Industry
Enrollment: 158 participants

Conditions and interventions

Conditions

Neoplasms, Breast

Interventions

lapatinib Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 12, 2009 (Actual)
Primary completion: Sep 18, 2012 (Actual)
Completion: Sep 18, 2012 (Actual)
Last update posted: Nov 13, 2017

2009 – 2012

United States locations

U.S. sites: 8
U.S. states: 6
U.S. cities: 8

Facility	City	State	ZIP	Site status
GSK Investigational Site	Scottsdale	Arizona	85259	—
GSK Investigational Site	Tucson	Arizona	85724	—
GSK Investigational Site	Washington D.C.	District of Columbia	20007	—
GSK Investigational Site	Fort Myers	Florida	33905	—
GSK Investigational Site	Atlanta	Georgia	30341	—
GSK Investigational Site	Detroit	Michigan	48202	—
GSK Investigational Site	Memphis	Tennessee	38120	—
GSK Investigational Site	Nashville	Tennessee	37203	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00996762, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 13, 2017 · Synced Nov 12, 2026