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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
GlaxoSmithKline
Study ID
NCT00682279
Phase
PHASE1
Status
Withdrawn

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • oral topotecan (SK&F-104864); lapatinib (GW572016) — DRUG
    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).

Study Details

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.

Key Dates

Start date
Sep 30, 2008
Status verified
Apr 2015
Primary completion
Mar 31, 2011
Completion
Mar 31, 2011

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • No Intervention: This is a single-arm, dose escalation
    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).

Primary Outcome Measure

The maximum-tolerated dose (MTD) regimen of the combination will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) after completing one treatment cycle. [ Time Frame: Study cancelled prior to FCI. ]

Locations (2)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteRochesterMinnesota55905-
GSK Investigational SitePhiladelphiaPennsylvania19104-

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By research site
GSK Investigational Site· Rochester, MNGSK Investigational Site· Philadelphia, PA

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