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Brief Title: Virexxa (Sodium Cridanimod) w/Progestin Therapy in Pts w/Progesterone Receptor Neg Recurrent/Persistent Endometrial CA
Official Title: A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma
Study ID: NCT02064725
Brief Summary: This is an open label, multi-center, single arm phase II study. The study will investigate the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of patients with recurrent or persistent PrR-negative endometrial cancer.
Detailed Description: This is an open label, multi-center, single arm phase II study. The study will investigate the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of patients with recurrent or persistent PrR-negative endometrial cancer. Eligible patients will be enrolled into the study and administered sodium cridanimod in combination progestin therapy. Objective responses will be assessed at 12 week intervals. Patients will be treated for a 12 month period, followed by an additional 12 month follow up period or to disease progression whichever occurs first. Important objectives of the study are to investigate the effect of sodium cridanimod in conjunction with progestin therapy on the level of PrR in tumor tissue and how this correlates to efficacy. To accomplish this objective, some of the patients enrolled in the study will undergo two tumor biopsies that will allow measurement of PrR levels in the tumor tissue before the treatment and after 4 weeks of therapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Physicians Research Group, San Jose, California, United States
St. Jude Hospital Yorba Linda, St. Joseph's Heritage Healthcare, Santa Rosa, California, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Montefiore Medical Center, Bronx, New York, United States
Brest Regional Clinical Hospital, Brest, , Belarus
Minsk City Clinical Oncology Dispensary, Minsk, , Belarus
N.N. Alexandrov National Cancer Centre of Belarus, Minsk, , Belarus
Vitebsk Regional Clinical Oncology Dispensary, Vitebsk, , Belarus
Masaryk Memorial Cancer Institute, Brno, , Czech Republic
University Hospital Hradec Kralove, Hradec Kralove, , Czech Republic
University Hospital Olomouc, Oncology, Olomouc, , Czech Republic
Oncology Institute of Saint Alzbeta, Bratislava, , Slovakia
Poko Poprad, s.r.o., Poprad, , Slovakia
University Hospital Trencin, Trencin, , Slovakia
Cherkasy Regional Oncology Dispensary, Cherkasy, , Ukraine
Municipal Institution of Dnipropetrovsk Regional Rada, Dnipropetrovsk, , Ukraine
Kharkiv Regional Clinical Oncology Center, Kharkiv, , Ukraine
S.P. Grigoryeva Institute of Medical Radiology, Kharkiv, , Ukraine
Kherson Regional Oncological Dispensary, Kherson, , Ukraine
Sumy State University, Sumy, , Ukraine
Vinnitsa Regional Clinical Oncology Center, Vinnitsa, , Ukraine
Name: Laura L. Douglass
Affiliation: Kevelt AS
Role: STUDY_DIRECTOR