A Phase II Study of Dalantercept for Treating Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Protocol
13-109
Full Title
A Phase II Evaluation of Dalantercept (NSC #757172, IND #116598), A Novel Soluble Recombinant Activin Receptor-Like Kinase 1 (ALK-1) Inhibitor Receptor-Fusion Protein, in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (GOG 170R)
Phase
II
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 ovarian, fallopian tube, or primary peritoneal 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 ovarian, fallopian tube, or primary peritoneal cancer that has returned or persists despite prior therapy.
  • Patients must have received one prior platinum-containing chemotherapy regimen and may have had up to one additional regimen of chemotherapy for recurrent disease.
  • 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.
  • This study is open to patients age 18 and older.

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

Disease(s)
Ovarian Cancer
Locations
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