UI Hospitals and Clinics

Clinical Trial Details

Short Title
Official 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
Description

Participants in this research study have ovarian, fallopian tube, or primary peritoneal cancer that has failed to respond to the initial chemotherapies and has re-grown after surgery, radiation therapy, or other forms of treatment. The purpose of this study is to determine the effectiveness of the drug dalantercept (also known as ACE 041) in treating cancer and to determine the types and severity of side effects caused by treatment with this drug. Dalantercept is an experimental drug. For cancer cells to grow they need to have nutrients supplied to them through blood vessels. Dalantercept is designed to work by blocking the growth of those blood vessels by inhibiting a pathway called ALK-1. By doing so, it is thought to prevent cancer cells from growing. Drugs that target the cancer's blood supply are known as anti-angiogenesis agents.

In addition to the treatment part of this study, the researchers plan to test tumors (if collected during a previous surgery) and some of blood. The purpose of this research is to determine if this testing can be used in the future to determine ahead of time which patients may respond to treatment or have better outcomes.

Approximately 10 people will take part in this study conducted by investigators at the University of Iowa. Up to 53 people may participate among all GOG institutions. Approximately 26 patients will be treated during the first stage of this study. After approximately 26 patients have entered the study, the study will be temporarily closed and an analysis of these patients will be done. Depending on the results of that analysis, the study may or may not reopen. If the study reopens, approximately 27 more patients may be treated during the second stage of the study.

Start Date
August 22, 2013
End Date
July 1, 2022
Gender Preference
Female
Age Group
18 - 99 years
Principal Investigator
David Bender, MD
Contact Info

Sharon Stockman, (319) 356-2015

Department
Department of Obstetrics and Gynecology
Keywords
201306790 ; Bender ; cancer ; Carcinoma ; Epithelial Ovarian Carcinoma ; Fallopian Tube Carcinoma ; Phase two ; Primary Peritoneal Carcinoma ;

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