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- W2891444002 abstract "2554 Background: Glucocorticoid receptor (GR) expression has been linked with chemotherapy resistance. Nonclinical and clinical studies have suggested that a GR antagonist (GRA) can enhance the efficacy of chemotherapy. Relacorilant (formerly CORT125134), a potent selective GRA, is being evaluated in solid tumors in combination with nab-pac. Methods: This ongoing phase 1/2 study is evaluating the tolerability, anticancer activity, and Phase 2 dose of relacorilant + nab-pac. Nab-pac is administered weekly for 3 of 4 weeks of a 28-day cycle. The study includes assessment of 2 relacorilant dosing schedules: continuous (CON) daily dosing and intermittent (INT) dosing (the day before, of, and after nab-pac). Pts ≥18 y old with advanced solid tumors, up to 3 prior lines of therapy in the advanced setting, ECOG status 0-1, and adequate renal, hepatic, and marrow function are included. Prior treatment with nab-pac is allowed. Results: As of Jan 1, 2018, 25 pts were enrolled; 17 had prior taxane. In CON dosing, 16 pts received 100 mg relacorilant/80 mg/m2 nab-pac and 1 received 100 mg relacorilant/60 mg/m2 nab-pac. In INT dosing, 4 pts received 200 mg relacorilant/150 mg/m2 nab-pac and 4 received 150 mg relacorilant/100 mg/m2 nab-pac. Grade ≥3 AEs included neutropenia (40%), anemia (12%), pneumonia (8%), mucosal inflammation (8%), and leukopenia (8%). Dose-limiting toxicity included neutropenia; GCSF support was added to regimens subsequently. Among pts treated to date, 1 unconfirmed CR (ovarian CA), 2 confirmed PRs (pancreatic CA, vulvar CA), and 5 SDs (2 ovarian CA, 2 pancreatic CA, 1 carcinoid) were observed. Pancreatic CA pt with confirmed PR has remained on study 48 weeks, despite having progressed within 14 weeks on earlier gemcitabine/nab-pac. For the 6 pts with available tissue, all had GR IHC results with ≥50% staining (range 50%-100%); 4/6 pts were responders; all 4 had ≥60% GR staining. Conclusions: An efficacy signal has been observed in pts with pancreatic and gynecologic CA previously treated with taxane. Neutropenia is manageable with GCSF support and dose modification. Expansions are planned, including pancreatic and ovarian CA cohorts. Clinical trial information: NCT02762981." @default.
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- W2891444002 date "2018-05-20" @default.
- W2891444002 modified "2023-09-23" @default.
- W2891444002 title "A phase 1/2 study of relacorilant + nab-paclitaxel (nab-pac) in patients (pts) with solid tumors: The dose-finding phase." @default.
- W2891444002 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.2554" @default.
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