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An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer

NCT03077698 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-06-07

Study results available
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Summary

This is an open-label, multi-center, single-arm, two-period Phase 2 study. The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with recurrent or persistent endometrial cancer, who have failed progestin monotherapy or who have been identified as Progesterone Receptor (PrR) negative. All patients must have endometrial cancer PrR status determined from an archival sample at Screening. The PrR status (positive or negative) will be determined by central laboratory by ImmunoHistoChemistry (IHC) testing.

There are two treatment periods and a follow-up period within the study.

Conditions

Interventions

DRUG

Sodium Cridanimod

The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with endometrial cancer, who have failed progestin monotherapy or who have been identified as PrR negative.

DRUG

progestin therapy

The study will investigator the use of progestin therapy in conjunction with Sodium Cridanimod

Sponsors & Collaborators

  • Xenetic Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Curtis Lockshin, PhD · Xenetic Biosciences, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2020-07-17
Completion
2020-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03077698 on ClinicalTrials.gov