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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 an investigational small molecule being studied for the treatment of refractory endometrial adenocarcinoma, a type of endometrial cancer. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Onapristone is a small molecule that targets the progesterone receptor. By blocking this receptor, it may inhibit the growth of hormone receptor positive endometrial cancer cells. It is being studied in combination with anastrozole for refractory endometrial cancer.
Onapristone is being developed by Context Therapeutics Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol CNTX.
Onapristone is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is active but not recruiting participants.
Onapristone is being studied in a Phase 2 clinical trial with the identifier NCT04719273. The trial is testing onapristone in combination with anastrozole for the treatment of refractory hormone receptor positive endometrial cancer, with an enrollment of 14 participants in the United States.
Yes, Onapristone is also known as extended-release Onapristone. This formulation is being studied in clinical trials for the treatment of refractory endometrial adenocarcinoma.