Spots Global Cancer Trial Database for An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer
Official Title: A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Endometrial Carcinoma
Study ID: NCT03077698
Conditions
Study Description
Brief 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.
Detailed Description: Treatment Period 1 (Progestin Monotherapy): During Treatment Period 1, all subjects determined to be PrR positive will receive progestin monotherapy, megestrol acetate, for up to 24 weeks. Subjects will have an MRI or CT scan after 12 and 24 weeks of progestin monotherapy, with response to treatment being assessed according to RECIST 1.1 criteria. All subjects that achieve disease control confirmed by tumor assessment after Treatment Period 1, will be ineligible to enter Treatment Period 2. These subjects will be terminated from the trial and treated according to local standards of practice, which may include continued progestin therapy. Subjects determined to be PrR negative at Screening will not enroll into Treatment Period 1. These subjects will enroll directly into Treatment Period 2. Treatment Period 2 (Combination Treatment): All subjects determined to be PrR negative at Screening and those who received at least 4 weeks of progestin monotherapy and who experienced disease progression at the conclusion of Treatment Period 1 will enter Treatment Period 2 of the study. During Treatment Period 2, subjects will receive Sodium Cridanimod in combination with continued progestin treatment, megestrol acetate. Subjects will receive treatment until disease progression as defined according to RECIST 1.1 criteria, with response assessments performed at 12-week intervals. Follow-up Period: Once subjects progress during Treatment Period 2, they will return for a Safety Follow-up Visit 4 weeks following the last treatment, and then continue to be followed for an additional 12-month period for overall survival.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Providence St. Joseph Medical Center - Gynecology, Burbank, California, United States
University of California - Irvine Healthcare, Irvine, California, United States
UCLA, Los Angeles, California, United States
St. Josephs Heritage Healthcare, Santa Rosa, California, United States
University of Colorado School of Medicine, Division of Gynecologic Oncology, Aurora, Colorado, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Sarasota Memorial Health Care System, Sarasota, Florida, United States
Northside Hospital [University Gynecologic Oncology], Atlanta, Georgia, United States
MUMC - Curtis and Elizabeth Anderson Cancer Institute, Savannah, Georgia, United States
Saint Alphonsus Regional Medical Center, Boise, Idaho, United States
RUSH University Medical Center, Chicago, Illinois, United States
University of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States
Women's Cancer Care [Mary Bird Cancer Center at Tammany Parish Hospital], Covington, Louisiana, United States
St. Dominic-Jackson Memorial Hospital, Jackson, Mississippi, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
Columbia University Medical Center, New York, New York, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
University of Cincinnati Cancer Institute-UC Health Barrett Center, Cincinnati, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC, Tulsa, Oklahoma, United States
Magee Women's Hospital (UPMC), Pittsburgh, Pennsylvania, United States
Rapid City Regional Cancer Care, Rapid City, South Dakota, United States
UT Southwestern, Dallas, Texas, United States
UT Galveston; University of Texas Medical Branch (UTMB), Galveston, Texas, United States
Seattle Cancer Care Alliance / University of Washington, Seattle, Washington, United States
Contact Details
Name: Curtis Lockshin, PhD
Affiliation: Xenetic Biosciences, Inc.
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
