Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors
NCT ID: NCT02762981
Last Updated: 2022-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
85 participants
INTERVENTIONAL
2016-05-23
2020-09-12
Brief Summary
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Detailed Description
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In Segment I continuous-dosing cohorts, participants received a single nab-paclitaxel lead-in infusion on Day 1 of Week -2 before Cycle 1, and oral relacorilant lead-in once-daily of Week -1 before Cycle 1. After the Data Review Committee review of data for 2 dose levels, the nab-paclitaxel lead-in was discontinued. The lead-in period was followed by oral relacorilant administered continuously once daily, in combination with nab-paclitaxel infusions on Days 1, 8, and 15 of each 28-day cycle. Segment 1 enrolled a total of 64 participants.
In Segment II intermittent-dosing cohorts, participants received a single relacorilant lead-in dose on Day -1 before Cycle 1, followed by oral relacorilant, administered intermittently the day before, the day of, and the day after nab-paclitaxel infusions on Days 1, 8, and 15 of each 28-day cycle. Segment II enrolled a total of 21 participants.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Relacorilant with nab-paclitaxel
Participants will be treated with relacorilant in combination with nab-paclitaxel at escalating dose levels in either a Continuous-Dosing Regimen or an Intermittent-Dosing Regimen.
Relacorilant with nab-paclitaxel
Relacorilant is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion.
Interventions
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Relacorilant with nab-paclitaxel
Relacorilant is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Some protocol specified treatments prior to the first dose of study drug.
18 Years
ALL
No
Sponsors
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Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
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038
Scottsdale, Arizona, United States
014
San Francisco, California, United States
001
Chicago, Illinois, United States
013
Ogden, Utah, United States
Countries
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References
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Pivonello R, Munster PN, Terzolo M, Ferrigno R, Simeoli C, Puglisi S, Bali U, Moraitis AG. Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant. Front Endocrinol (Lausanne). 2022 Jan 4;12:793262. doi: 10.3389/fendo.2021.793262. eCollection 2021.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A phase 1/2 study of relacorilant + nab-paclitaxel (nab-pac) in patients (pts) with solid tumors: The dose-finding phase
Relacorilant (RELA) with nab-paclitaxel (NP): Safety and activity in patients with pancreatic ductal adenocarcinoma (PDAC) and ovarian cancer (OvCA)
Other Identifiers
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CORT125134-550
Identifier Type: -
Identifier Source: org_study_id
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