Clinical trial · Interventional
An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer
A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Endometrial Carcinoma
NCT03077698CI-TRIAL-00058936terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was discontinued due to a change in development strategy and not due safety concern.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| progestin therapy | Drug | — | UNRESOLVED |
| Sodium Cridanimod | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sodium Cridanimod & progestin therapy
- description
- Sodium Cridanimod and progestin therapy (megestrol acetate) combination
- interventionNames
- Drug: Sodium Cridanimod
- Drug: progestin therapy
Primary outcomes (1)
- measure
- Overall Disease Control (ODC) as Determined by Radiographic Imaging Measurements
- timeFrame
- During TP2 Every 12 weeks, until disease progression up to 24 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.