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Relacorilant with nab-paclitaxel

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment85
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02762981Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid TumorsPHASE1 COMPLETED 85May 23, 2016Sep 12, 2020Dec 6, 20224 United States
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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 — 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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