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



Status:Active, not recruiting
Conditions:Cervical Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/23/2018
Start Date:June 14, 2017
End Date:January 31, 2021

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

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.

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.

Inclusion Criteria:

1. Female patients 18 years of age or older;

2. Histologically confirmed serous carcinoma or endometrioid type of endometrial
carcinoma (histological documentation of recurrence is not required);

3. Recurrent or persistent progressive disease which is refractory to curative therapy or
established treatments and cannot be treated with surgery or radiotherapy;

4. Measurable disease, as defined by RECIST 1.1 criteria;

5. 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;

6. Availability of archived tumor tissue sample that can be used for assessment of PrR
status by the central laboratory;

7. GOG performance status 0-2 (refer to Appendix A);

8. Calculated Glomerular filtration rate ≥ 50 mL/min;

9. Total bilirubin ≤ 2.5 times upper limit of normal (ULN);

10. AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases);

11. Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver
metastases);

12. Albumin ≥ 3.0 mg/dL;

13. Ability to take oral medication;

14. Patients able to understand the nature of the study and who are willing to give
written informed consent;

15. And for Treatment Period 2 only: 1) Patients participating in Treatment Period 1 must
have had disease progression after receiving at least 4 weeks of progestin therapy or
2) Patients must be determined as PrR negative status at Screening.

Exclusion Criteria:

1. Mixed histology of the tumor or evidence of tumor histology other than serous
carcinoma or endometrioid type of endometrial carcinoma;

2. Concurrent systemic corticosteroid therapy;

3. Concurrent oral contraceptive use / Women of childbearing potential not using highly
effective means of contraception;

4. Pregnancy confirmed by pregnancy test / Lactating women;

5. Prior therapy with hormonal progestin agents;

6. Patients who are candidates for treatment with standard chemotherapy agents (there is
no limit to the number of lines of chemotherapy);

7. History of blood clot;

8. History of known bleeding disorder (i.e. disseminated intravascular coagulation or
clotting factor deficiency);

9. Major surgery within 4 weeks prior to the start of the study;

10. Patients with clinically significant illnesses which, according to the Investigator,
could compromise participation in the study;

11. History of other clinically active malignancies within 5 years, except for carcinoma
in situ of the cervix, basal cell carcinoma, or squamous carcinoma of the skin.

12. Known hypersensitivity or idiosyncratic reaction to any of the study drugs (Sodium
Cridanimod, megestrol acetate, lidocaine) and excipients;

13. Patients with known brain metastases;

14. Patients currently receiving any other investigational agents;

15. Patients currently receiving any other anticancer therapies;

16. Participation in any other clinical study within the last 4 weeks prior to the start
of the study
We found this trial at
25
sites
Savannah, Georgia 31404
Principal Investigator: James Burke, MD
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
Principal Investigator: Yi-Chun Lee, MD
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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Brooklyn, NY
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960 Johnson Ferry Road
Atlanta, Georgia 30342
Principal Investigator: Meaghan Tenney, MD
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Atlanta, GA
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1665 Aurora Court
Aurora, Colorado 80045
Principal Investigator: Bradley Corr, MD
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Aurora, CO
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1055 N Curtis Rd
Boise, Idaho 83706
(208) 367-2121
Principal Investigator: Alan Langerak, MD
Saint Alphonsus Regional Medical Center Saint Alphonsus Health System is a four-hospital regional, faith-based Catholic...
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Boise, ID
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501 South Buena Vista Street
Burbank, California 91505
Principal Investigator: Raul R. Mena, MD
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Burbank, CA
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Summer Dewdney, MD
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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234 Goodman Street
Cincinnati, Ohio 45219
Principal Investigator: Thomas Herzog, MD
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Cincinnati, OH
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1203 South Tyler Street
Covington, Louisiana 70433
Principal Investigator: Patricia Braly, MD
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Covington, LA
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Dallas, Texas 75390
Principal Investigator: David Miller, MD
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Dallas, TX
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301 University Boulevard
Galveston, Texas 77555
Principal Investigator: Gwyn Richardson, MD
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Galveston, TX
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Irvine, California 92697
Principal Investigator: Krishnansu Tewari, MD
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Irvine, CA
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Jackson, Mississippi 32916
Principal Investigator: Paul Seago, MD
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Jackson, MS
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Jacksonville, Florida 32207
Principal Investigator: Paul W. Nowicki, MD
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Jacksonville, FL
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Lexington, Kentucky
Principal Investigator: Lauren Baldwin, MD
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Lexington, KY
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Gottfried Konecny, MD
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Los Angeles, CA
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: June Hou, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Orlando, Florida 32804
Principal Investigator: James Kendrick, MD
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Orlando, FL
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Principal Investigator: Alexander Olawaiye, MD
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Pittsburgh, PA
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353 Fairmont Boulevard
Rapid City, South Dakota 57701
Principal Investigator: Helen Frederickson, MD
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Rapid City, SD
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1165 Montgomery Drive
Santa Rosa, California 95403
Principal Investigator: Sara Keck, MD
Phone: 707-521-3830
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Santa Rosa, CA
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Sarasota, Florida 34239
Principal Investigator: James Fiorica, MD
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Sarasota, FL
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Seattle, Washington 98109
Principal Investigator: Heidi Gray, MD
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Seattle, WA
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Tulsa, Oklahoma 74146
Principal Investigator: Michael Gold, MD
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Tulsa, OK
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Winston-Salem, North Carolina 27157
Principal Investigator: Samuel Lentz, MD
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Winston-Salem, NC
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