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

  • Interventional
  • Not Recruiting
  • NCT02762981
Eligibility Details Visit Clinicaltrials.gov

Phase 1/2 Study of CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors

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.

The study will consist of two segments to evaluate alternative dosing schedules of CORT125134 (Part 1) and a dose expansion which will occur once the development regimen for Segment I and Segment II has been determined (Part 2). Segment I will evaluate a continuous-dosing regimen and Segment II will evaluate an intermittent-dosing regimen. Enrollment in Segment I and Segment II will be mutually exclusive, and the two segments will enroll patients concurrently.

     Segment I, Part 1: dose-escalation cohorts will be enrolled with approximately 62 patients to determine the maximum tolerated dose (MTD) and the development regimen for the continuous-dosing regimen. Treatment will be administered in 28-day cycles.

     A continuous dosing cohort will be explored in patients with pancreatic cancer. Segment I, Part 2: Enrollment in Part 2 of the study (dose expansion) will occur once the development regimen for Segment I has been determined.

     Segment II, Part 1: dose-escalation cohorts will be enrolled with approximately 24 patients to determine the MTD and the development regimen for the intermittent-dosing regimen. Treatment on Segment II Part I will be administered in 28-day cycles.

     Segment II, Part 2: Enrollment in Part 2 of the study (dose expansion) will occur once the development regimen for Segment II has been determined.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.
  • Solid Tumors

At a Glance

National Government IDNCT02762981

IRB#IRB16-0046

Lead SponsorCorcept Therapeutics

Lead PhysicianGini Fleming

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting