Virexxa (Sodium Cridanimod) w/Progestin Therapy in Pts w/Progesterone Receptor Neg Recurrent/Persistent Endometrial CA
NCT02064725 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2017-01-24
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.
Conditions
- Recurrent or Persistent Endometrial Carcinoma
Interventions
- DRUG
-
Sodium cridanimod
Eligible patients will be enrolled into the study and administered sodium cridanimod (500 mg i.m./ twice a week) in combination with megestrol acetate (160 mg p.o./ day) or medroxyprogesterone acetate (200 mg p.o./ day).
Sponsors & Collaborators
-
Pharmasyntez
collaborator INDUSTRY -
Kevelt AS
lead INDUSTRY
Principal Investigators
-
Laura L. Douglass · Kevelt AS
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-30
- Primary Completion
- 2018-01-31
- Completion
- 2018-07-31
Countries
- United States
- Belarus
- Czechia
- Slovakia
- Ukraine
Study Locations
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