Trials / Completed
CompletedNCT03909152
A Study of Onapristone ER Alone Or In Combination With Anastrozole in Gynecologic Cancers That Respond to Progesterone
Basket Study of the Oral Progesterone Antagonist Onapristone ER (Apristor), Alone or In Combination With Anastrozole in Women With Progesterone Receptor Positive (PR+) Recurrent Granulosa Cell Tumor, Low Grade Serous Ovarian Cancer or Endometrioid Endometrial Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test any good and bad effect of the study drug, onapristone extended-release (ER) alone and in combination with anastrozole.
Conditions
- Granulosa Cell Ovarian Cancer
- Low Grade Serous Ovarian/ Primary Peritoneal Cancer
- Endometrioid Endometrial Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Onapristone ER | 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent. |
| DRUG | Onapristone ER + Anastrozole | Onapristone ER Patients will take 50 PO BID in the form of two 20 mg tablets and one 10 mg tablet taken with food and water twice daily. Patients will be prescribed anastrozole 1mg PO QD. Anastrozole will be taken once daily in the AM with patients morning dose of onapristone ER. |
Timeline
- Start date
- 2019-05-02
- Primary completion
- 2024-09-03
- Completion
- 2024-09-03
- First posted
- 2019-04-09
- Last updated
- 2025-07-28
- Results posted
- 2025-07-28
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03909152. Inclusion in this directory is not an endorsement.