Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Corcept Therapeutics
- Study ID
- NCT02762981
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Relacorilant with nab-paclitaxel — DRUGRelacorilant is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion.
Study Details
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 Dates
- First listed
- May 5, 2016
- Start date
- May 23, 2016
- Status verified
- Nov 2022
- Primary completion
- May 12, 2020
- Completion
- Sep 12, 2020
Study Design
- Enrollment
- 85 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Relacorilant with nab-paclitaxelParticipants will be treated with relacorilant in combination with nab-paclitaxel at escalating dose levels in either a Continuous-Dosing Regimen or an Intermittent-Dosing Regimen.
Primary Outcome Measure
Number of Participants With Dose-limiting Toxicity [ Time Frame: Up to completion of Cycle 1 (up to 28 days) ]
Locations (4)
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