A Phase II Study of Dalantercept to Treat Recurrent or Persistent Endometrial Cancer

Protocol
12-180
Full Title
A Phase II Evaluation of Dalantercept, a Novel Soluble Recombinant Activin Receptor-Like Kinase 1 (ALK-1) Inhibitor Receptor-Fusion Protein, in the Treatment of Recurrent or Persistent Endometrial Carcinoma (GOG-0229N)
Purpose

The purpose of this Gynecologic Oncology Group study is to evaluate the safety and effectiveness of an investigational drug called dalantercept in patients with endometrial cancer that has returned or persists despite prior therapy. Dalantercept is designed to stop the development of the blood vessels tumors need to grow and spread. It works by targeting a protein called ALK-1. The drug is given using a subcutaneous (under the skin) injection.

Eligibility

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

  • Patients must have endometrial cancer that has returned or persists despite at least one but no more than two prior regimens of chemotherapy.
  • Patients must have recovered from the serious side effects of prior therapies before entering the study. At least 3 weeks must have passed since completion of chemotherapy and 4 weeks since radiation therapy or major surgery.
  • Patients who had one prior regimen of therapy must be able to be ambulatory for more than half of their normal waking hours.
  • Patients who had two prior regimens of therapy 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.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Vicky Makker at 646-888-4224.

Disease(s)
Endometrial and other Uterine Cancers: Endometrial Cancer
Locations