Trial ID # | NCT03776812 |
Phase | II |
Drug Class | Hormonal Therapy: GR |
Drug Name | Relacorilant |
Alternate Drug Names | RELA, CORT125134 |
Drugs in Trial | nab-Paclitaxel, Relacorilant |
Eligible Participant | Platinum resistant and refractory ovarian cancer |
Patients Enrolled | 178 |
Therapy Setting | Recurrence |
Study Design | Open-Label, Randomized |
Endpoints | ORR, DoR, PFS, OS, evaluated per RECIST |
Efficacy | Intermittent Rel+Nab (n=60) vs Nab (n=60): ORR: 35.7 vs 35.8% High tumor GR: GR IHC H-score ≥100 (65%, 82/129):
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Clinically Significant Adverse Events | Intermittent Rel+Nab vs Nab: |
Conclusion | Intermittent relacorilant+nab-paclitaxel improves PFS and DoR and has a favorable safety profile in recurrent platinum resistant and/or platinum refractory ovarian cancer patients |
Reference | Lorusso D et al. Relacorilant, a selective glucocorticoid receptor modulator, in combination with nab-paclitaxel improves progression-free survival in patients with recurrent platinum-resistant ovarian cancer: A 3-arm, randomized, open-label, phase II study. Annals Oncol (2021) 32 (suppl_5): abstract 721O Colombo N et al. Overall survival data from a 3-arm, randomized, open-label, phase 2 study of relacorilant, a selective glucocorticoid receptor modulator, combined with nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer. J Clin Oncol 40, 2022 (suppl 17; abstr LBA5503) Colombo N et al. Slide from presentation Lorusso D et al. Glucocorticoid receptor expression and activity in a phase II ovarian cancer trial of the glucocorticoid receptor modulator relacorilant in combination with nab-paclitaxel. ESMO (2022) Abstract 524MO |