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Also known as Extended-release Onapristone
Onapristone · 1 trial · 7 indications
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...
Onapristone is being studied for the treatment of refractory endometrial adenocarcinoma, a type of endometrial cancer that has not responded to prior therapy. It is an investigational small molecule being developed in oncology for patients with hormone receptor positive disease that has progressed after earlier treatment.
Onapristone targets the progesterone receptor, or PGR, and acts as an antagonist. By blocking this receptor, the drug is designed to interfere with progesterone-driven signaling that can support the growth of hormone-sensitive tumors such as endometrial adenocarcinoma.
Onapristone is being developed by Context Therapeutics Inc., which trades under the ticker CNTX. The company is advancing the drug as an extended-release small molecule for refractory endometrial adenocarcinoma and related endometrial cancer subtypes.
Onapristone is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. The ongoing study is evaluating the drug in patients with refractory endometrial adenocarcinoma, and no completed trials of Onapristone have been recorded.
Onapristone is being evaluated in the Phase 2 trial NCT04719273, titled Onapristone and Anastrozole for the Treatment of Refractory Hormone Receptor Positive Endometrial Cancer. The trial is active but not recruiting, is enrolling 14 female participants aged 18 years and older, and is being conducted in the United States.
Yes, extended-release Onapristone is another name for Onapristone. Both refer to the same investigational small molecule developed by Context Therapeutics Inc. for refractory endometrial adenocarcinoma, so searches using either name point to the same drug candidate.