Phase 2
Completed N=85
Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors
Source: ClinicalTrials.gov NCT02762981 ↗Enrolled (actual)
85
Serious AEs
54.8%
Results posted
Dec 2022
Primary outcomePrimary: Number of Participants With Dose-limiting Toxicity — 0; 8; 2; 2 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-limiting Toxicity |
0; 8; 2; 2; 3 | — |
| SECONDARY Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant |
13; 24; 5; 13; 5 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02762981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.