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

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Angiogenesis Inhibitors; Sunitinib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed advanced/metastatic solid tumor

• Having received at least 1 prior systemic therapy for the treatment of advanced/metastatic solid tumors

• Histologically or cytologically confirmed renal cell carcinoma with clear cell histology and evidence of metastasis (No previous systemic therapy for the treatment of metastatic renal cell carcinoma)

• Adequate laboratory tests

• Eastern Cooperative Oncology Group (ECOG) 0-1, Life expectancy > or = 12 weeks and age > or = 18 years

Exclusion Criteria:

• Patients intolerant of prior anti-angiogenic agents

• Recent history of bleeding or bleeding disorders

• History of tumors in the brain

• History of heart problems

• History of severe allergic reaction to antibody therapy