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Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors

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ClinicalTrials.gov Identifier: NCT02762981
Recruitment Status : Completed
First Posted : May 5, 2016
Results First Posted : December 6, 2022
Last Update Posted : December 6, 2022
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

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

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: Relacorilant with nab-paclitaxel Phase 1 Phase 2

Detailed Description:

The study consisted of two segments to evaluate alternative dosing schedules of relacorilant administered at escalating dose levels. Segment I was to evaluate a continuous-dosing regimen and Segment II was to evaluate an intermittent-dosing regimen. Enrollment in Segment I and Segment II were mutually exclusive, and the two segments enrolled participants concurrently.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors
Actual Study Start Date : May 23, 2016
Actual Primary Completion Date : May 12, 2020
Actual Study Completion Date : September 12, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Relacorilant with nab-paclitaxel
Relacorilant is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion.
Other Names:
  • Abraxane
  • Nanoparticle albumin-bound paclitaxel
  • CORT125134


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Dose-limiting Toxicity [ Time Frame: Up to completion of Cycle 1 (up to 28 days) ]
    The Maximum Tolerated Dose and the development regimen of relacorilant with nab-paclitaxel was determined by the number of participants with dose-limiting toxicities as defined in the protocol.


Secondary Outcome Measures :
  1. Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant [ Time Frame: Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years) ]
    Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.


Other Outcome Measures:
  1. Objective Response Rate [ Time Frame: Up to 512 days ]
    Objective response rate is defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as best response of complete response (CR) or partial response (PR) from the start of relacorilant or nab-paclitaxel, whichever is earliest, across all time points during study observation period (including both confirmed and unconfirmed responses).

  2. Clinical Benefit Rate [ Time Frame: Up to 512 days ]
    Clinical benefit rate is defined as the participants who have achieved CR or PR (including both confirmed and unconfirmed responses), or stable disease for 16 weeks or greater.

  3. Duration of Response [ Time Frame: From the time of response up to the last disease assessment (up to 512 days) ]
    Duration of response (DOR) is defined as the date that criteria are met for CR or PR until the first date that progressive disease or death is objectively documented, whichever occurs first. Participants with no documentation of disease progression or death on-study are censored at the date of last available tumor assessment

  4. Progression-free Survival [ Time Frame: Up to 512 days ]
    Progression-free survival is defined as the time from date of first dose of relacorilant or nab-paclitaxel, whichever is earliest, to the date of documented disease progression per RECIST v1.1 or death for any cause, whichever occurs first. Participants with no documentation of disease progression or death on-study are censored at the date of last available tumor assessment.

  5. Overall Survival [ Time Frame: Up to 512 days ]
    Overall survival is defined as the time from date of the first dose of relacorilant or nab paclitaxel, whichever is earliest, to the date of death for any cause. Participants with no documentation of death on-study are censored at the date at which they are last known to be alive.

  6. Best Response Rate in Participants With Tumor Glucocorticoid Receptor (GR) Above or Below the Median Overall Level [ Time Frame: Up to 512 days ]
    Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of relacorilant or nab-paclitaxel, whichever is earliest, across all time points during study observation period (including both confirmed and unconfirmed responses).

  7. Pharmacokinetics: Area Under the Concentration-time Curve From Zero to 24 Hours (AUC0-24) of Plasma Relacorilant [ Time Frame: Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 ]
  8. Pharmacokinetics: AUC0-24 of Plasma Nab-Paclitaxel [ Time Frame: Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 ]
  9. Pharmacokinetics: Maximum Concentration (Cmax) of Plasma Relacorilant [ Time Frame: Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 ]
  10. Pharmacokinetics: Cmax of Plasma Nab-Paclitaxel [ Time Frame: Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762981


Locations
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United States, Arizona
038
Scottsdale, Arizona, United States, 85258
United States, California
014
San Francisco, California, United States, 94143
United States, Illinois
001
Chicago, Illinois, United States, 60637
United States, Utah
013
Ogden, Utah, United States, 84403
Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Medical Monitor Corcept Therapeutics
  Study Documents (Full-Text)

Documents provided by Corcept Therapeutics:
Study Protocol  [PDF] January 13, 2020
Statistical Analysis Plan  [PDF] October 14, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT02762981    
Other Study ID Numbers: CORT125134-550
First Posted: May 5, 2016    Key Record Dates
Results First Posted: December 6, 2022
Last Update Posted: December 6, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corcept Therapeutics:
CORT125134
nab-paclitaxel
Triple-Negative Breast Cancer
Ovarian Epithelial Cancer
GR Antagonist
 Glucocorticoid Receptor Antagonist
Pancreatic Cancer
Solid Tumors
Relacorilant
Abraxane
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action