Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04719273 | Onapristone and Anastrozole for the Treatment of Refractory Hormone Receptor Positive Endometrial Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 14 | — | — | Jan 28, 2021 | Dec 31, 2025 | Jan 8, 2025 | 2 | United States |
Defined by the percentage of patients with tumor response (complete response \[CR\] or partial response \[PR\]) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
4 month PFS is defined as a binary endpoint, from first dose of onapristone and anastrozole to 4 months of therapy as "confirmed progression-free" or "not progression-free" (including cancer progression or censored subjects). Will use the date of first documented disease progression or recurrence, as assessed by using RECIST 1.1 criteria, or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Treatment (onapristone, anastrozole) | EXPERIMENTAL | Patients receive onapristone PO BID and anastrozole PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles (24 months) until November 30, 2023 or in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Extended-release Onapristone | DRUG | Given PO |
| Anastrozole | DRUG | Given PO |
| Quality-of-Life Assessment | OTHER | Ancillary studies |
| Questionnaire Administration | OTHER | Ancillary studies |
| Estrogen Receptor Positive (Positive Estrogen Receptor; ESR Positive; ESR1 Positive; ER Positive; Estrogen Receptor Alpha Positive) | DIAGNOSTIC_TEST | Immunohistochemistry (IHC):Integral : Tissue |
| Progesterone Receptor Positive ( PGR Positive; PR Positive) | DIAGNOSTIC_TEST | Immunohistochemistry (IHC) |
Inclusion Criteria: * Age greater than or equal to 18 years old * Histologically confirmed diagnosis of endometrial cancer with ER and/or PR expression \>= 1% by IHC on archival tissue taken within the prior 3 years or new biopsy if no archival tissue is available. IHC results do not have to be fro...