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Relacorilant with nab-paclitaxel

Phase 1

Solid Tumors | Small molecule | Oncology |Corcept Therapeutics Incorporated|Last Updated: Dec 6, 2022

Target and mechanism

Molecular targetNR3C1
Target classAntagonist
ModalitySmall molecule

Also known as relacorilant, Relacorilant

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

Relacorilant with nab-paclitaxel · 1 trial · 1 indication

Phase 1 1
NCT02762981Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid TumorsSolid Tumors
COMPLETED85 Analytics
PHASE1COMPLETED
Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Dose-limiting Toxicity
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 Endpoints

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)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Relacorilant with nab-paclitaxelEXPERIMENTALParticipants 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

NameTypeDescription
Relacorilant with nab-paclitaxelDRUGRelacorilant is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 myelosup...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about Relacorilant with nab-paclitaxel

What is Relacorilant used for?

Relacorilant is an investigational small molecule being studied for use in Cushing syndrome, solid tumors, recurrent ovarian cancer, adenocarcinoma, and hepatic impairment. It is being developed by Corcept Therapeutics Incorporated (CORT) and is currently in Phase 2 clinical development for these indications.

What does Relacorilant target?

Relacorilant is a selective glucocorticoid receptor modulator. It works by binding to the glucocorticoid receptor, which is involved in regulating various physiological processes. This mechanism is being studied for its potential effects in oncology and endocrine conditions like Cushing syndrome.

Who makes Relacorilant?

Relacorilant is being developed by Corcept Therapeutics Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker symbol CORT. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.

What phase is Relacorilant in?

Relacorilant is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, with one active Phase 2 study currently recruiting participants. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is Relacorilant in?

Relacorilant has been studied in several clinical trials. NCT02762981 evaluated it with nab-paclitaxel in solid tumors, NCT03604198 is an extension study in Cushing syndrome, NCT05347979 assessed its effect on drug interactions, and NCT07259317 is an ongoing Phase 2 trial in metastatic pancreatic adenocarcinoma.

Is Relacorilant the same as CORT125134?

Yes, Relacorilant is also known as CORT125134. The clinical trial NCT02762981, which studied the drug in combination with nab-paclitaxel in solid tumors, explicitly refers to Relacorilant as CORT125134 in its title.