A Phase II Study of Axitinib plus Dalantercept or Placebo for Patients with Metastatic Kidney Cancer

Protocol
12-255
Full Title
A Phase 2 Randomized, Double-Blind, Study of Dalantercept plus Axitinib Compared to Placebo Plus Axitinib in Patients with Advanced Renal Cell Carcinoma
Phase
I/II
Purpose

Axitinib is an approved therapy for advanced renal cell carcinoma (a form of kidney cancer). Dalantercept is an investigational drug that works by inhibiting the maturation of the blood vessels that tumors need to grow and spread.

In this study, researchers want to determine how effective and safe it is to add dalantercept to axitinib in patients with renal cell carcinoma that has spread (metastasized) and cannot be surgically removed. They hope that the combination of both drugs is more effective for treating kidney cancer than either medication alone. Axitinib is given orally (by mouth), while dalantercept is given via injection under the skin.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable metastatic renal cell carcinoma of clear-cell type that continued to grow despite one prior regimen of sunitinib or pazopanib.
  • Patients must have been previously treated with one and only one prior drug (either pazopanib or sunitinib).
  • At least 2 weeks must have passed since the last dose of sunitinib or pazopanib or any radiation therapy and entry into the study.
  • Patients may not have received prior treatment with axitinib or dalantercept.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Voss at 646-422-4631.

Disease(s)
Locations
Related Diseases