Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors
Completed · Phase 1/Phase 2
Conditions studied: Solid Tumors
In brief
The purpose of this study was to assess the safety of the combination of relacorilant (CORT125134), a novel glucocorticoid receptor (GR) antagonist, and nab- paclitaxel in participants with solid tumors and to determine the preliminary efficacy of the combination of relacorilant and nab-paclitaxel. The structure for the study was a single arm, non-randomized, open- label, multicenter trial with no control group.
Key facts
- Study ID
- NCT02762981
- Run by
- Corcept Therapeutics
- People needed
- 85
- Starts
- 2016-05-23
- Expected to finish
- 2020-09-12
- Last updated by the study team
- 2022-12-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants with advanced or metastatic solid tumors who have disease progression after treatment with available therapies and for whom nab-paclitaxel treatment is appropriate.
- Measurable or evaluable disease.
- Up to 3 prior cytotoxic chemotherapeutics regimens or myelosuppressive therapies in the advanced setting.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- For Part 2 Only: Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer, or Triple Negative Breast Cancer with measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in at least 1 lesion, that in the opinion of the Investigator is appropriate to treat with nab-paclitaxel.
You may not qualify if…
- Any major surgery within 4 weeks prior to the first dose of study drug.
- Some protocol specified treatments prior to the first dose of study drug.
Where it is running
- 038 — Scottsdale, Arizona, United States
- 014 — San Francisco, California, United States
- 001 — Chicago, Illinois, United States
- 013 — Ogden, Utah, United States
Full record on ClinicalTrials.gov
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