Study of Pazopanib, Irinotecan and Cetuximab in Combination to Treat 2nd Line Metastatic Colorectal Cancer

Phase 1

Completed

• Conditions: Neoplasms, Colorectal
• Interventions: Drug: Pazopanib; Drug: Cetuximab; Drug: Irinotecan

• Registration Number: NCT00540943
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Subjects will be entered into cohorts of 3 for the dose escalation phase so that the maximum tolerated dose can be determined. 18 additional patients will be recruited once the maximum tolerated dose (MTD) is determined for disease assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-13
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Primary Completion: 2010-05-03
• Study Completion: 2010-05-03
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Pazopanib	irinotecan and cetuximab in combination with pazopanib.
Single Arm	Cetuximab	irinotecan and cetuximab in combination with pazopanib.
Single Arm	Irinotecan	irinotecan and cetuximab in combination with pazopanib.

Primary Outcome Measures

Name	Time	Method
The safety and tolerability of the maximum tolerated dose defined as a dose regimen where no more than 1 of 6 subjects experiences a dose limiting toxicity.	End of 2009

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics disease assessment	2010
Clearance of irinotecan (if data permit) and AUC, Cmax, tmax, and t1/2 of irinotecan and SN-38 after administration of irinotecan plus cetuximab.	2010
AUC(0-24), Cmax, tmax, and t1/2 of pazopanib when administered with irinotecan and cetuximab	2010
AUC(0-24), Cmax, and tmax of cetuximab when administered with irinotecan alone	2010
AUC(0-24), Cmax, and tmax of cetuximab when administered with irinotecan plus pazopanib.	2010
The ratio of SN-38 AUC(0-24) and irinotecan AUC(0-24) on Cycle 1 Day 1 and on Cycle 2 Day 1.	2010
Objective response rate (complete response (CR) plus partial response (PR)) will be the primary measure of antitumor activity	2010
Time to progression	2010
Stable disease (SD) at 4 months	4 months

Trial Locations

Locations (1)

GSK Investigational Site; 🇫🇷 Toulouse, France