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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:May 2016
End Date:June 2020
Contact:550 Study Team
Email:corceptstudy550@corcept.com

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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.

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.
We found this trial at
4
sites
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Ogden, Utah 84403
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San Francisco, California 94143
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Scottsdale, Arizona 85258
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