Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumours
• Interventions: Drug: topotecan; Drug: pazopanib

• Registration Number: NCT00732420
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To determined what dose of topotecan can be safely given with daily pazopanib.

Detailed Description

A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in combination with Pazopanib in Subjects with Advanced Solid Tumors

Study Timeline

• Study First Submitted: 2008-08-11
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-12
• Study Start: 2008-09-24
• Primary Completion: 2013-06-12
• Study Completion: 2013-06-12
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm A	pazopanib	Daily oral pazopanib in combination with weekly oral topotecan. Initially rising dose to determine the maximum tolerated dose: finally an expanded cohort treated at the maximum tolerated dose.
Treatment Arm B	pazopanib	Daily oral pazopanib in combination with oral topotecan given for 5 consecutive days every 21 days. Initially rising dose to determine the maximum tolerated dose; finally an additional cohort of patients treated at the maximum tolerated dose.
Treatment Arm B	topotecan	Daily oral pazopanib in combination with oral topotecan given for 5 consecutive days every 21 days. Initially rising dose to determine the maximum tolerated dose; finally an additional cohort of patients treated at the maximum tolerated dose.
Treatment Arm A	topotecan	Daily oral pazopanib in combination with weekly oral topotecan. Initially rising dose to determine the maximum tolerated dose: finally an expanded cohort treated at the maximum tolerated dose.

Primary Outcome Measures

Name	Time	Method
First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily.	5 weeks

Secondary Outcome Measures

Name	Time	Method
Indications of efficacy through tumour shrinkage. Specific biomarker analysis.	12 weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇳🇱 Utrecht, Netherlands