Study of Pazopanib, Irinotecan and Cetuximab in Combination to Treat 2nd Line Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00540943|
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : November 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms, Colorectal||Drug: Pazopanib Drug: Cetuximab Drug: Irinotecan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Safety and Pharmacokinetics of Pazopanib in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer|
|Actual Study Start Date :||July 13, 2007|
|Actual Primary Completion Date :||May 3, 2010|
|Actual Study Completion Date :||May 3, 2010|
Experimental: Single Arm
irinotecan and cetuximab in combination with pazopanib.
Pazopanib is a potent, multi-targeted tyrosine kinase inhibitor of VEGFR-1, -2, -3, PDGFR-alpha and -beta and c-kit.
Cetuximab will be supplied as a single-use 50 milliliter vial containing 100 micrograms of cetuximab as a sterile, preservative-free, injectable liquid at a concentration of 2 milligram per milliliter in phosphate.
Irinotecan hydrochloride trihydrate is an antineoplastic agent of the topoisomerase I inhibitor class.
- 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. [ Time Frame: End of 2009 ]
- pharmacokinetics disease assessment [ Time Frame: 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. [ Time Frame: 2010 ]
- AUC(0-24), Cmax, tmax, and t1/2 of pazopanib when administered with irinotecan and cetuximab [ Time Frame: 2010 ]
- AUC(0-24), Cmax, and tmax of cetuximab when administered with irinotecan alone [ Time Frame: 2010 ]
- AUC(0-24), Cmax, and tmax of cetuximab when administered with irinotecan plus pazopanib. [ Time Frame: 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. [ Time Frame: 2010 ]
- Objective response rate (complete response (CR) plus partial response (PR)) will be the primary measure of antitumor activity [ Time Frame: 2010 ]
- Stable disease (SD) at 4 months [ Time Frame: 4 months ]
- Time to progression [ Time Frame: 2010 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540943
|GSK Investigational Site|
|Saint Herblain, France, 44805|
|GSK Investigational Site|
|Toulouse, France, 31052|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|