Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors
Phase 1/2 Study of CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors
1 other identifier
interventional
85
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2016
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedStudy Start
First participant enrolled
May 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2020
CompletedResults Posted
Study results publicly available
December 6, 2022
CompletedDecember 6, 2022
November 1, 2022
4 years
April 11, 2016
July 28, 2022
November 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Dose-limiting Toxicity
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.
Up to completion of Cycle 1 (up to 28 days)
Secondary Outcomes (1)
Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant
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)
Other Outcomes (10)
Objective Response Rate
Up to 512 days
Clinical Benefit Rate
Up to 512 days
Duration of Response
From the time of response up to the last disease assessment (up to 512 days)
- +7 more other outcomes
Study Arms (1)
Relacorilant with nab-paclitaxel
EXPERIMENTALParticipants 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.
Interventions
Relacorilant is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
038
Scottsdale, Arizona, 85258, United States
014
San Francisco, California, 94143, United States
001
Chicago, Illinois, 60637, United States
013
Ogden, Utah, 84403, United States
Related Publications (1)
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.
PMID: 35058882DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Corcept Therapeutics
Study Officials
- STUDY DIRECTOR
Medical Monitor
Corcept Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2016
First Posted
May 5, 2016
Study Start
May 23, 2016
Primary Completion
May 12, 2020
Study Completion
September 12, 2020
Last Updated
December 6, 2022
Results First Posted
December 6, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share