Study of ONA-XR in Women With PR+ Recurrent Granulosa Cell Tumor of the Ovary
Trial Status:
Enrollment in this Phase 2 study is open.
For More Trial Information:
Please contact info@contextherapeutics.com or visit clinicaltrials.gov.
ClinicalTrials.gov Identifier:
NCT03909152 (Link)
Program (Target):
Onapristone extended release (ONA-XR) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting the binding of progesterone receptor to chromatin, down regulating cancer stem cell mobilization, and blocking immune evasion. [1,2] ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.
Clinical Trial Description:
A multicenter, open-label, Simon 2-stage adaptive Phase 2 trial to evaluate the efficacy and safety of the anticancer agent ONA-XR in combination with the antiestrogen anastrozole in advanced granulosa cell tumors of the ovary that are progesterone receptor positive (PR+). The primary endpoint will assess the overall response rate (ORR), which is the proportion of patients that have either a complete or partial response, obtained with ONA-XR in each of these tumors. The secondary objectives of the study will include endpoints to better characterize the activity of ONA-XR, such as duration of response, clinical benefit, and progression-free survival (PFS). In addition, this study will evaluate the safety and pharmacological profile of ONA-XR in these patients, as well as biomarker analyses to explore predictive factors of drug response.
Trial Sites:
| City | State | Institution |
|---|---|---|
| Basking Ridge | New Jersey | Memorial Sloan Kettering Basking Ridge |
| Montvale | New Jersey | Memorial Sloan Kettering Bergen |
| Middletown | New Jersey | Memorial Sloan Kettering Monmouth |
| Commack | New York | Memorial Sloan Kettering Commack |
| New York | New York | Memorial Sloan Kettering Cancer Center |
| Rockville Centre | New York | Memorial Sloan Kettering Rockville Centre |
| Harrison | New York | Memorial Sloan Kettering Westchester |
[1] Huang, Y, et al. (2018) Inhibiting Nuclear Phospho-Progesterone Receptor Enhances Antitumor Activity of Onapristone in Uterine Cancer. Mol Cancer Ther. 2018 Feb;17(2):464-473. doi: 10.1158/1535-7163.
[2] Cottu PH, et al. (2018) Phase I study of onapristone, a type I antiprogestin, in female patients with previously treated recurrent or metastatic progesterone receptor-expressing cancers. PLoS ONE 13(10): e0204973. https://doi.org/10.1371/journal.pone.0204973