Study to Evaluate CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors

• Status: Completed
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety of the combination of CORT125134, a novel glucocorticoid receptor (GR) antagonist, and nab- paclitaxel in patients with solid tumors and to determine the preliminary efficacy of the combination of CORT125134 and nab-paclitaxel. The structure for the study is a single arm, non-randomized, open- label, multicenter trial with no control group.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Patients 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.