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A Phase I Study Of Oral Topotecan And Lapatinib In Subjects With Advanced Solid Tumors

NCT00682279 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-04-17

No results posted yet for this study

Summary

This is an open-label, Phase I study of oral topotecan administered in combination with lapatinib in subjects with advanced solid tumors. This Phase I study will evaluate the safety, tolerability, and pharmacokinetics of oral topotecan administered in combination with lapatinib. This study will be conducted in two parts. Part 1 of the study will investigate the impact of lapatinib on the bioavailability of oral topotecan (bioavailability phase) and Part 2 of the study will consist of dose finding to determine the maximum-tolerated dose (MTD) regimen of the combination (dose escalation phase). In Part 2 of the study, the dose of oral topotecan will be escalated while lapatinib will be given initially as fixed doses. The primary objective of the study is to determine the MTD regimen of oral topotecan administered for five-consecutive days every 21 days in combination with daily lapatinib in subjects with advanced solid tumors.

Conditions

Interventions

DRUG

oral topotecan (SK&F-104864); lapatinib (GW572016)

This is a single-arm, dose escalation, Phase I study in which doses of oral topotecan will be escalated and lapatinib will be given initially as a fixed dose. This study will examine oral topotecan administered on a five-consecutive day schedule in combination with daily lapatinib. This study will be conducted in two parts. Part 1 of the study will investigate the impact of lapatinib on the bioavailability of oral topotecan (bioavailability phase) and Part 2 of the study will consist of dose finding to determine the MTD regimen of the combination (dose escalation phase).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00682279 on ClinicalTrials.gov