Endometrial Cancer Clinical Trial
Official title:
A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Endometrial Carcinoma
Verified date | May 2022 |
Source | Xenetic Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 25 |
Est. completion date | July 17, 2020 |
Est. primary completion date | July 17, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 (Gynecologic Oncology Group) 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northside Hospital [University Gynecologic Oncology] | Atlanta | Georgia |
United States | University of Colorado School of Medicine, Division of Gynecologic Oncology | Aurora | Colorado |
United States | Saint Alphonsus Regional Medical Center | Boise | Idaho |
United States | SUNY Downstate Medical Center | Brooklyn | New York |
United States | Providence St. Joseph Medical Center - Gynecology | Burbank | California |
United States | RUSH University Medical Center | Chicago | Illinois |
United States | University of Cincinnati Cancer Institute-UC Health Barrett Center | Cincinnati | Ohio |
United States | Women's Cancer Care [Mary Bird Cancer Center at Tammany Parish Hospital] | Covington | Louisiana |
United States | UT Southwestern | Dallas | Texas |
United States | UT Galveston; University of Texas Medical Branch (UTMB) | Galveston | Texas |
United States | University of California - Irvine Healthcare | Irvine | California |
United States | St. Dominic-Jackson Memorial Hospital | Jackson | Mississippi |
United States | Baptist MD Anderson Cancer Center | Jacksonville | Florida |
United States | University of Kentucky, Markey Cancer Center | Lexington | Kentucky |
United States | UCLA | Los Angeles | California |
United States | Columbia University Medical Center | New York | New York |
United States | Florida Hospital Cancer Institute | Orlando | Florida |
United States | Magee Women's Hospital (UPMC) | Pittsburgh | Pennsylvania |
United States | Rapid City Regional Cancer Care | Rapid City | South Dakota |
United States | St. Josephs Heritage Healthcare | Santa Rosa | California |
United States | Sarasota Memorial Health Care System | Sarasota | Florida |
United States | MUMC - Curtis and Elizabeth Anderson Cancer Institute | Savannah | Georgia |
United States | Seattle Cancer Care Alliance / University of Washington | Seattle | Washington |
United States | Oklahoma Cancer Specialists and Research Institute, LLC | Tulsa | Oklahoma |
United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Xenetic Biosciences, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Disease Control (ODC) as Determined by Radiographic Imaging Measurements | Subjects in the Full Analysis Set (FAS) population will be assessed for ODC. The FAS population includes those subjects all treated in TP2 who either undergo a CT or MRI scan with tumor assessment at 12 weeks (i.e. they have not discontinued treatment prior to 12 weeks) or those who have discontinued TP2 prior to 12 weeks solely due to documented disease progression. Radiographic disease progression and responses will be defined using RECIST 1.1 criteria:
Control Response(CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions. The appearance of new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD |
During TP2 Every 12 weeks, until disease progression up to 24 months | |
Secondary | Objective Response Rate (ORR) | The best overall response was the best response recorded from the start of Treatment Period 2 until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).To be assigned a status of CR or PR, tumor measurements were confirmed by repeat assessment performed at least four weeks after the criteria for response are first met. Best Overall Response (OR) was determined based on the following combinations of repeat assessments: CR + CR = CR, CR + PR= SD, PD or PR, CR + SD =SD, CR+ PD = SD, CR + NEW= SD, PR + CR= PR, PR + PR= PR, PR+ SD= SD, PR + PD= SD, PR+ NEW = SD. | 24 months | |
Secondary | Progression-free Survival (PFS) | Progressive Disease was assessed using RECIST Guideline (version 1.1) whereas at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Progression-free Survival (PFS) was defined as the duration of time from initiation of Treatment Period 2 (Day 0) until disease progression or death from any cause, whichever occurs first. For the purpose of analysis of PFS, subjects with an unknown response were censored. | 24 months | |
Secondary | Duration of Stable Disease | Stable Disease (SD) was assessed using RECIST Guideline (version 1.1) whereas neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Duration of Stable Disease was defined as the duration of time from initiation of Treatment Period 2 (Day 0) until the criteria for disease progression were first met. For the purpose of analysis of Duration of SD, subjects who died before documented progressive disease were censored. | 24 months | |
Secondary | Overall Survival (OS) | Once disease progression was documented in Treatment Period 2, subjects returned for the Safety Follow-up Visit four (4) weeks following the last treatment and continued to be followed for an additional 12-month period for overall survival. Overall Survival (OS) was defined as the duration of time from initiation of Treatment Period 2 (Day 0) until the subject's death from any cause. For the purpose of analysis of OS, if a subject is alive at the date of last contact the subject was censored at that date of contact. | 12 months |
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