GOG-0170R

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

Principal Investigator

Robert A. Burger

Status

Disease Site

Gynecologic [GY] Ovarian

Phase

II

Developmental Therapeutics

No

Primary Objective

To estimate the proportion of patients who survive progression-free for at
least 6 months and the proportion of patients who have objective tumor
response (complete or partial) in patients with persistent or recurrent
epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, treated
with dalantercept.

To determine the frequency and severity of adverse events associated with
treatment with dalantercept as assessed by the Active Version of the
National Cancer Institute (NCI) Common Terminology Criteria for
Adverse Events (CTCAE).

Patient Population

Patients who survive progression-free for at least 6 months and patients who have objective tumor response (complete or partial) in patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, treated
with dalantercept.

Target Accrual

56