drugset / Trial / NCT00982657

A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma

NCT00982657

Phase 2 Terminated 34 enrolled Pfizer
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The safety and tolerability of CVX-060 have been established in the first-in-human clinical trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and pharmacokinetics (PK) profiles of combining CVX-060 with sunitinib in patients with advanced solid tumors, and to subsequently assess the treatment efficacy of the combination treatment, as well as that of sunitinib alone in patients with advanced renal cell carcinoma (mRCC).

Timeline

Start
2009-09
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject CVX-060 Protein / enzyme biologic 6 mg/kg
Subject CVX-060 Protein / enzyme biologic 12 mg/kg
Subject CVX-060 Protein / enzyme biologic 15 mg/kg
Comparator Sunitinib Small molecule 50 mg

Indications