Trial Summary

Official Title

A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Endometrial Carcinoma

Status

Recruiting

Condition

Endometrial Cancer

Actual Start Date

June 14, 2017

Estimated Primary Completion Date

January 31, 2021

About the Trial

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

The primary objective of the open-label, multi-center, single-arm, two-period Phase 2 study is to assess the antitumor activity of XBIO-101 in conjunction with progestin therapy as measured by Overall Disease Control Rate in women with recurrent or persistent endometrial carcinoma not amenable to surgical treatment or radiotherapy who have either failed progestin monotherapy or who have been identified as PrR-negative.

Secondary objectives of the study are to assess progression-free survival, time to response, time to progression, duration of overall survival and Overall Disease Control Rate for subjects receiving XBIO-101 and progestin therapy; and to evaluate the safety and tolerability of XBIO-101 in conjunction with progestin therapy, as measured by adverse events, laboratory safety parameters, and cardiac safety assessments. 

The study is expected to enroll a total of 72 women with recurrent or persistent endometrial cancer not amenable to surgical treatment or radiotherapy but suitable to be treated with progestin. All subjects determined to be PrR-negative at screening, as well as those subjects who experience disease progression after at least four weeks of progestin monotherapy, will receive XBIO-101 in combination with continued progestin treatment. Subjects will receive treatment until disease progression as defined according to RECIST 1.1 criteria.

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 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 IHC testing.

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


Study Phase

Phase 2

Estimated Enrollment

72

Estimated Primary Completion Date

January 31, 2021

Study Type

Interventional

Sponsor

Xenetic Biosciences, Inc.

Interventions
  • Drug: Sodium Cridanimod
  • Drug: progestin therapy

Eligibility

Gender

Female

18+

Age

18 years and older

Inclusion Criteria

  • Female patients 18 years of age or older;
  • Histologically confirmed serous carcinoma or endometrioid type of endometrial carcinoma (histological documentation of recurrence is not required);
  • Recurrent or persistent progressive disease which is refractory to curative therapy or established treatments and cannot be treated with surgery or radiotherapy;
  • Measurable disease, as defined by RECIST 1.1 criteria;
  • At least one "target lesion" to be used to assess response, as defined by RECIST 1.1 criteria. Tumors within a previously irradiated field will be designated as "non-target" lesions unless previous progression is documented;
  • Availability of archived tumor tissue sample that can be used for assessment of PrR status by the central laboratory;
  • GOG performance status 0-2 (refer to Appendix A);
  • Calculated Glomerular filtration rate ≥ 50 mL/min;
  • Total bilirubin ≤ 2.5 times upper limit of normal (ULN);
  • AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases);
  • Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases);
  • Albumin ≥ 3.0 mg/dL;
  • Ability to take oral medication;
  • Patients able to understand the nature of the study and who are willing to give written informed consent;
  • And for Treatment Period 2 only: 1) Patients participating in Treatment Period 1 must have had disease progression after receiving at least four weeks of progestin therapy or 2) Patients must be determined as PrR negative status at screening.

Exclusion Criteria

  • Mixed histology of the tumor or evidence of tumor histology other than serous carcinoma or endometrioid type of endometrial carcinoma;
  • Concurrent systemic corticosteroid therapy;
  • Concurrent oral contraceptive use/women of childbearing potential not using highly effective means of contraception;
  • Pregnancy confirmed by pregnancy test/lactating women;
  • Prior therapy with hormonal progestin agents;
  • Patients who are candidates for treatment with standard chemotherapy agents (there is no limit to the number of lines of chemotherapy);
  • History of blood clot;
  • History of known bleeding disorder (i.e. disseminated intravascular coagulation or clotting factor deficiency);
  • Major surgery within four weeks prior to the start of the study;
  • Patients with clinically significant illnesses which, according to the Investigator, could compromise participation in the study;
  • History of other clinically active malignancies within five years, except for carcinoma in situ of the cervix, basal cell carcinoma, or squamous carcinoma of the skin.
  • Known hypersensitivity or idiosyncratic reaction to any of the study drugs (Sodium Cridanimod, megestrol acetate, lidocaine) and excipients;
  • Patients with known brain metastases;
  • Patients currently receiving any other investigational agents;
  • Patients currently receiving any other anticancer therapies;
  • Participation in any other clinical study within the last four weeks prior to the start of the study.

Location

The following cities have XBIO-101 clinical trial sites. Please check back often as locations will be updated.

Providence St. Joseph Medical Center - Gynecology
Burbank, California 91505
United States
Status: Recruiting

University of California - Irvine Healthcare
Irvine, California 92697
United States
Status: Recruiting

UCLA
Los Angeles, California 90024
United States
Status: Recruiting

St. Josephs Heritage Healthcare
Santa Rosa, California 95403
United States
Status: Recruiting

University of Colorado School of Medicine, Division of Gynecologic Oncology
Aurora, Colorado 80045
United States
Status: Recruiting

Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
United States
Status: Recruiting

Florida Hospital Cancer Institute
Orlando, Florida 32804
United States
Status: Recruiting

Sarasota Memorial Health Care System
Sarasota, Florida 34239
United States
Status: Recruiting

Northside Hospital [University Gynecologic Oncology]
Atlanta, Georgia 30342
United States
Status: Recruiting

MUMC - Curtis and Elizabeth Anderson Cancer Institute
Savannah, Georgia 31404
United States
Status: Recruiting

Saint Alphonsus Regional Medical Center
Boise, Idaho 83706
United States
Status: Recruiting

RUSH University Medical Center
Chicago, Illinois 60612
United States
Status: Not yet recruiting

University of Kentucky, Markey Cancer Center
Lexington, Kentucky 40508
United States
Status: Recruiting

Women's Cancer Care [Mary Bird Cancer Center at Tammany Parish Hospital]
Covington, Louisiana 70433
United States
Status: Recruiting

St. Dominic-Jackson Memorial Hospital
Jackson, Mississippi 39216
United States
Status: Recruiting

SUNY Downstate Medical Center
Brooklyn, New York 11203
United States
Status: Recruiting

Columbia University Medical Center
New York, New York 10032
United States
Status: Recruiting

Wake Forest Baptist Health
Winston-Salem, North Carolina 27517
United States
Status: Not yet recruiting

University of Cincinnati Cancer Institute-UC Health Barrett Center
Cincinnati, Ohio 45219
United States
Status: Recruiting

Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma 74146
United States
Status: Recruiting

Magee Women's Hospital (UPMC)
Pittsburgh, Pennsylvania 15213
United States
Status: Recruiting

Rapid City Regional Cancer Care
Rapid City, South Dakota 57701
United States
Status: Recruiting

UT Southwestern
Dallas, Texas 75390
United States
Status: Recruiting

UT Galveston; University of Texas Medical Branch (UTMB)
Galveston, Texas 77555
United States
Status: Recruiting

Seattle Cancer Care Alliance / University of Washington
Seattle, Washington 98109
United States
Status: Recruiting