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 |
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.
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.
(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.
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