Trial reportInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society2025
Basket study of oral progesterone antagonist onapristone extended-release in combination with anastrozole in progesterone receptor-positive recurrent adult-type granulosa cell tumor of the ovary.
Trial report in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- A phase II study of androgen receptor inhibition by darolutamide in combination with leuprolide acetate and exemestane in recurrent adult-type ovarian granulosa cell tumor.Gynecologic oncology · 2026Trial
- Phase II clinical trial of nirogacestat in patients with relapsed ovarian granulosa cell tumours.Clinical and translational medicine · 2026Trial
Corrections and comments
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Authors and funding
20 authors.
Funding
Abstract
objectiveWe sought to determine the safety and efficacy of the oral progesterone antagonist onapristone in combination with anastrozole in patients with recurrent progesterone receptor-positive adult-type granulosa cell tumor of the ovary.
methodsThis was a single-institution phase II study of patients with progesterone receptor-positive adult-type granulosa cell tumor who received at least 1 prior line of chemotherapy. Patients were enrolled from November 2021 to August 2022 and tissue was evaluated for progesterone receptor status via immunohistochemistry. Eligible patients had progesterone receptor expression ≥1% on tissue collected within 3 years of enrollment. Patients received 50 mg of onapristone extended-release twice daily and 1 mg of anastrozole by mouth daily until progression of disease or discontinuation of treatment. Adverse events were graded by Common Terminology Criteria for Adverse Events version 5.0. The primary end point was the overall response rate by Response Evaluation Criteria in Solid Tumors version 1.1. Secondary end points were response duration, clinical benefit rate, progression-free survival, and safety.
resultsFourteen patients with adult-type granulosa cell tumor enrolled and completed stage 1 accrual. There were no objective responses seen during the study period. The study was closed when further development of onapristone extended-release was discontinued. All 14 patients were evaluable, with median progression-free survival of 3.6 months (range; 1.7-7.1), a 6-month progression-free survival rate of 28.6% (range; 8.8%-52.4%), a 12-month progression-free survival rate of 10.7% (range; 0.8%-35.4%), and a clinical benefit rate of 42.9% (range; 17.7%-71.7%).
conclusionThe study did not meet its primary end point. Although the combination of onapristone extended-release and anastrozole was well-tolerated, there were no objective responses in patients with progesterone receptor-positive adult-type granulosa cell tumor.
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