A Phase I Study Of Oral Topotecan And Lapatinib In Subjects With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT00682279. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I, Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Oral Topotecan in Combination With Lapatinib in Subjects With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00682279
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- Not listed
Conditions and interventions
Conditions
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
- Aug 31, 2008
- Primary completion
- Feb 28, 2011
- Completion
- Feb 28, 2011
- Last update posted
- Apr 16, 2015
2008 – 2011
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Rochester | Minnesota | 55905 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00682279, 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 Apr 16, 2015 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00682279 live on ClinicalTrials.gov.