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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02064725 on ClinicalTrials.gov